Johnson & Johnson Verdict Will Harm Chronic Pain Patients

By Barby Ingle, PNN Columnist

This week an Oklahoma judge ruled that Johnson & Johnson helped fuel the state’s opioid crisis and ordered the company to pay $572 million in damages.

I watched the entire 7 weeks of the Oklahoma trial and hoped that Judge Thad Balkman would get this right. I do not believe that he did. Johnson & Johnson may have the funds available to pay such a big penalty, but what about the healthcare providers, pharmacies, insurers, FDA, DEA and drug abusers who also played a role in causing the crisis?

This verdict shows that pain patients in America are once again being overlooked for the lives of drug addicts. Both problems need to be addressed: addiction and chronic pain.

I am a chronic pain patient who has been mistreated, undertreated, overtreated and misdiagnosed over the years. Do I think the $572 million is going to make a difference in my care or other pain patients? No, I don’t. We have already seen patients commit suicide because they were taken off opioid medications that were helping them cope with life and manage their pain.

The insurance companies won’t cover the other treatments and for some patients who have tried those treatments and failed, opioids were the only thing giving them quality of life.

Now we see a rise in the suicide rate and overdoses are still high. And where is the problem really coming from? Street drugs.

How is a manufacturer of opioids held liable, but people who chose to abuse drugs are not held accountable? Is it because they can’t make money off poor people?

The Oklahoma verdict is not holding the right people accountable by any reasonable standard. It distorts the public nuisance law beyond recognition and will take away more options and choices from pain patients. This is only the start. Nearly 2,000 other opioid lawsuits are awaiting trial.

Why force these pharmaceutical companies into settlements? Why force an industry that saves millions of lives to do this? We need the industry to keep working on treatments. Less than 5% of the 7,000 rare diseases have any treatment options available. Are these lives less valuable than addicts’ lives? We need to stop forsaking one life for another.

I for one hope that Johnson & Johnson appeals for the sake of the pain community and for the sake of all who need pain medications -- be it for an acute situation such as kidney stones, a shattered pelvis or a chronic illness such as Reflex Sympathetic Dystrophy, arachnoiditis, sickle cell or lupus.

I don’t believe that the pharmaceutical industry started, fueled or conspired to create the largest public health crisis of our time. I don’t believe there is an opioid epidemic. Addiction does affect millions of people but in many cases the help they need has not been provided. Billions of dollars in federal funding, including grants from President Trump’s opioid initiatives, haven’t been fully set up or spent to make a difference.

I believe it's up to the providers and pharmacists to tell us about the risks associated with opioids. They do in most cases. We as chronic pain patients want to have all options on the table. It's going to take a multi-modal approach that will have to start with human behavior and people being responsible for their own actions.

Insurance companies are already using tactics such as step therapy, prior authorization and stall tactics to prevent people from getting proper treatment. This is being done to both the addiction and chronic pain communities. It saves insurers millions of dollars, yet they are not being held accountable for care that is being denied.

For those in pain it's important to have opioids available and it’s not a simple matter of pharmaceutical companies being all bad and responsible for everything that happens to society.

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.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study: Cannabis Flowers Rich in THC More Effective for Pain Relief

By Pat Anson, PNN Editor

Another study by researchers at the University of New Mexico suggests that tetrahydrocannabinol (THC) -- the psychoactive ingredient in marijuana – should not be ignored as a treatment for chronic pain.

In an unconventional survey of nearly 3,000 cannabis users, researchers found that those who used whole cannabis flowers or buds rich in THC reduced their pain levels an average of three points on a 0 to 10 pain score. Those who ingested cannabidiol (CBD) did not experience similar pain relief.

The researchers relied on information collected from the Releaf App, a mobile software program they created that allows cannabis users to self-report their experiences using different cannabis products, including flowers, edibles, tinctures and ointments.. Their findings are published in the journal Complementary Therapies in Medicine.

"Perhaps the most surprising result is just how widespread relief was with symptom relief reported in about 95 percent of cannabis administration sessions and across a wide variety of different types of pain," said Xiaoxue Li, PhD, an assistant professor of economics at UNM.

"Cannabis likely has numerous constituents that possess analgesic properties beyond THC, including terpenes and flavonoids, which likely act synergistically for people that use whole dried cannabis flower," added Jacob Miguel Vigil, PhD, a professor in UNM’s Department of Psychology. "Cannabis offers the average patient an effective alternative to using opioids for general use in the treatment of pain with very minimal negative side effects for most people."

The authors caution that cannabis use does carry the risk of addiction and short-term impairment in cognitive and behavioral functioning.

“Cannabis with high THC also causes mood elevation and adjusts attentional demands, likely distracting patients from the aversive sensations that people refer to (as) pain," explains Vigil.

Previous studies using data from the Releaf app found that cannabis also provides relief from insomnia, seizures, depression, anxiety and fatigue. Despite conventional wisdom, THC was found to be more important than CBD in generating therapeutic benefits.

A significant weakness of the app is that it relies on cannabis users to subjectively self-report their experiences outside of a clinical setting. There is also no way to measure the quality or quantity of the cannabis they are ingesting.   

Two-Thirds of Americans Accept Cannabis as Pain Treatment   

Another new survey – conducted by the American Society of Anesthesiologists (ASA) – found wide acceptance of cannabis as a possible treatment for pain. The online survey 1,005 adults was conducted earlier this month.

More than two-thirds of those surveyed said they have used or would consider using cannabis to manage pain. Nearly three-quarters of millennials fall in that category. Two-thirds of Gen Xers and baby boomers expressed interest in cannabis, with 25% of Gen Xers and 18% of baby boomers saying they have used cannabis for pain.

Most of those who expressed interest in using cannabis products believe they are safer or have fewer side effects than opioids or other medications.

Other key findings:

• 57% believe more cannabis research is needed

• 34% don't feel a need to discuss cannabis use with their doctor

• 13% believe no other type of pain management works for them

• 40% wrongly believe CBD products sold at grocery stores, truck stops, health food stores and dispensaries are approved by the FDA.

The ASA recently endorsed two bills that seek to expand research on CBD and marijuana: the Medical Cannabis Research Act and the Cannabidiol and Marihuana Research Expansion Act. The bipartisan bills would increase the number of manufacturers allowed to grow cannabis for research purposes and streamline the application process.

“As experts in managing pain, physician anesthesiologists are concerned about the lack of research regarding the safety and effectiveness of marijuana and cannabinoids," said ASA President Linda Mason, MD.

Oklahoma Judge Orders J&J to Pay $572 Million in Damages

By Pat Anson, PNN Editor

In a precedent setting case, an Oklahoma judge has ruled that Johnson & Johnson is partly responsible for fueling Oklahoma’s opioid crisis and ordered the health care giant to pay $572 million in damages.

“The opioid crisis has ravaged the state of Oklahoma and must be abated immediately,” said Cleveland County District Judge Thad Balkman, reading his decision aloud from the bench.

Balkman said J&J concocted a ‘marketing scheme” for opioid pain medication that overstated the drugs’ effectiveness and underplayed their risks. The company’s subsidiary, Janssen Pharmaceutical, produced less than one percent of the opioids prescribed in Oklahoma, but supplied 60% of the ingredients in painkillers sold by other companies.  

“They developed and carried out a plan to directly influence and convince doctors to prescribe more and more opioids, despite the fact that defendants knew increasing the supply of opioids would lead to abuse, addiction, misuse, death and crime,” the judge said.

Oklahoma had asked for $17.5 billion from J&J to pay for addiction treatment, emergency care, law enforcement and other services needed to address the opioid crisis. J&J said it would appeal the judges “flawed” ruling.

"Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome," Michael Ullmann, Executive Vice President and General Counsel for J&J, said in a statement. “This judgment is a misapplication of public nuisance law that has already been rejected by judges in other states.

"The unprecedented award for the State's 'abatement plan' has sweeping ramifications for many industries and bears no relation to the Company's medicines or conduct." 

Balkman’s ruling is not legally binding on any other court, but as the first opioid case to go to trial, it is expected to have a significant impact on negotiations to resolve nearly 2,000 lawsuits filed by states, cities and counties against opioid makers, distributors and pharmacies. Many of those cases have been consolidated before a federal judge in Ohio.

Oklahoma previously reached a $270 million out-of-court settlement with Oxycontin-maker Purdue Pharma and an $85 million deal with Teva Pharmaceutical. Endo International and Allergan recently agreed to pay $10 million and $5 million respectively to two Ohio counties to avoid going to trial.

Compared to the cost and bad publicity that J&J went through defending itself in Oklahoma, those settlements look prescient.

As PNN has reported, three law firms that acted as lead outside counsel for Oklahoma stand to collect 25% of the damages and penalties awarded to the state. Oklahoma’s star witness, anti-opioid activist Dr. Andrew Kolodny, testified that he was paid $500,000 for his services at a rate of $725 an hour.

Cost of MS Drugs Soars Despite Competition

By Pat Anson, PNN Editor

The cost of multiple sclerosis drugs has soared over the past decade for Medicare patients to nearly $76,000 per patient annually, according to a new study published in JAMA Neurology.

"We're not talking about patients without health insurance here," said senior author Inmaculada Hernandez, PharmD, assistant professor of pharmacy at the University of Pittsburgh. "We're talking about insured patients, under Medicare. Still, they are paying much more for multiple sclerosis drugs than they were 10 years ago."

Hernandez and her colleagues looked at Medicare Part D claims data from 2006 to 2016 for disease modifying therapies (DMTs) that reduce the frequency and severity of multiple sclerosis (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.

Some of the most widely used DMTs for treating MS are Copaxone, Tecfidera and Avonex. Although there’s a fair amount of competition between the drugs -- the FDA has approved 19 DMTs for MS – prices have risen in tandem for nearly all of them.

The annual list prices of the drugs more than quadrupled over the 2006-2016 study period, far outpacing inflation.

Not only did the researchers find steep increases in list prices -- the starting point before rebates, coupons or insurance kicks in -- but also in the ultimate costs to both Medicare and its beneficiaries.

"We wanted to see how increases in list prices translated to increases in out-of-pocket spending, and we discovered that actual price increases do get passed down to patients, and that can negatively affect access," said Hernandez.

Alvaro San-Juan-Rodriguez

When it was first introduced by Biogen in 1996, Avonex had an annual list price of about $8,700. Two decades later, Avonex costs nearly $76,000 per patient per year.

“The pharmaceutical and biotechnology industries claim that the high prices reflect the expense of research and development and need to incentivize continued innovation. These claims are never backed up with transparent data,” said Daniel Hartung, PharmD, and Dennis Bourdette, MD, in an editorial in JAMA Neurology. “These drugs have long since recouped any cost of drug development, yet their prices have continued to rise.

“What is driving this increase is uncertain. However, the simplest explanation is that pharmaceutical and biotechnology companies increase prices because they can, they do it to increase their profit margins, and there are few limits on what they can charge.”

Hartung and Bourdette say neurologists who prescribe DMTs should be more aware of their cost. A generic DMT made by Mylan, for example, sells for about $2,000 a month, compared to a branded version that sells for about $6,000.  

Chronic Pain Patients Are Collateral Damage of the Opioid Crisis

By Diana Franklin, Guest Columnist

I have been watching the news a lot lately. It seems like much of the coverage is devoted to the opioid crisis, and rightfully so. But I feel it’s a little one-sided.

I fully understand the issue with illegal drugs, doctors overprescribing, pharmaceutical companies flooding markets with powerful pills, and how all of that is a very big problem. I hate that so many are addicted and something needs to be done to stop it.

However, I also know that there are law abiding citizens in serious, legitimate pain that are getting swept up in the chaos and suffering because of it. These people feel like they're being punished and forgotten about. I know this, because I am one of them.

I had severe scoliosis as a kid. When I was 12, I was told it was progressing so quickly that I could end up bedridden or possibly dead by the age of 21. I had to have surgery to straighten and fuse a large portion of my spine with metal rods. Luckily, the surgery was a success.

When I was in my 30’s, one of the discs that hadn't been fused in my lower back slipped. A doctor did two laminectomies, where they shaved down the back side of the vertebrae. A year later, I had another surgery on the cervical spine in my neck.

These surgeries may have fixed the problem with the discs, but unfortunately the damage was done and I was left with severe nerve damage and in constant pain.

DIANA FRANKLIN

I saw a pain management specialist and tried several different pain medications until I found something that helped. I was still very limited in what I could do, but I was at least able to get out of the house on occasion, though I was unable to work and had to go on disability.

While battling these health issues, I lost my husband and had to find a way to survive with my two sons. This was made even more difficult when my pain started getting worse. I got an MRI which revealed that I also have degenerative disc disease. There is very little space between the few discs in my lower back that aren't fused, meaning that bone is rubbing on bone, crushing the nerves and causing tremendous pain.

With oxycodone, I was still in a great deal of pain, but as long as I didn't get up and do too much, I could push through the day. I always took less than needed and tried hard to manage the pain any other way before I took my pills. I had regular drug tests, per my doctor’s protocol, to ensure that I wasn't taking too much.

I have seen this doctor for 20 years and he always went above and beyond, with all of his patients, to ensure that he only gave them what they need to control their pain without becoming addicted.

Recently, the government stopped allowing my doctor to prescribe any opioids, leaving many of his patients, including myself, without any pain medication at all. Due to the pain and nerve damage, I have trouble walking, my hands and arms will hurt and swell up, and my back feels like it's being crushed. I have severe migraines and often end up crying due to the pain.

I can hardly get up to go across the room without help and every step causes extreme pain. I can't think straight and wind up exhausted because every ounce of energy I have goes to fighting the pain.

Because there is so much damage to my spine, managing the pain is my only real option. The few other options I have aren't covered by insurance and there’s no guarantee that they will help. They could possibly make my situation worse.

My life has gone from enjoying my kids and young grandkids to being essentially trapped in my recliner, not knowing how much longer I can live with the pain.

I have been strongly against illegal drugs all my life. I believe that the government should do what it can to make sure criminals aren't getting their hands on these medications and crackdown on doctors that overprescribe them.

However, by taking pain medication away from everyone, they have made me collateral damage. Patients like me, even those with cancer, are being left without any pain medication at all. Some have committed suicide because they just can't handle the pain.

I am trying hard to fight against thoughts like that, but it is difficult when every moment is spent in excruciating pain. Something has to be done to allow doctors to prescribe pain medicine to those who truly need it, without fear of government prosecution. Put in strict regulations, drug testing and criteria that people have to meet, so that those in legitimate pain can still be given the lifesaving pain relief that they desperately need.

I don't have all the answers, but I know that something needs to be done and we need to be heard. Please, don't sit by as so many suffer. People like me fight our battles every day just to survive, but it gets harder every second that we're in blinding, unthinkable pain.

People talk all the time about the people who die in overdoses. That is indeed a tragedy, but what no one wants to talk about are the people dying simply because they can't cope with the amount of pain that they're in. We need a solution and we need it now! More than anything, we need a loud voice to be heard above all the other shouting that seems to be surrounding this issue.

Please help me get the word out, not just about my story, but so many other stories out there of people in pain. I want as many people as possible, especially lawmakers, to see this and understand what we go through. Please like and share with everyone you can.

Diana Franklin lives in Texas.

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

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Online Censorship of Health Information Is Authoritarianism

By A. Rahman Ford, PNN columnist

Critics of stem cell therapy have taken their censorship campaign to another frightening and paternalistic step up the authoritarian ladder. Not only does it threaten freedom of speech, freedom of association and freedom of health, but now it’s targeting poor people.

The campaign to stop people from accessing stem cell therapy (SCT) has been building for some time. First there was fearmongering to scare patients away from SCT, followed by a push to have regulatory agencies increase enforcement.  Then came a call for social media platforms like YouTube to censor patient testimonials about the benefits of SCT.

Now, in a disturbing turn, critics are pressuring fundraising platforms like GoFundMe to purge campaigns that seek to raise funds for SCT.

In a recent op/ed in the BBC’s Future, London-based neurologist Dr. Jules Montague argues that crowdfunding sites like GoFundMe need to crackdown on patients seeking to raise money for stem cell treatments. Montague says their testimonials omit the “unfounded hype” and potential risks associated with SCT. These “bad actors,” according to Montague, should be banned to “halt the spread of misinformation.”

To propose that crowdfunding sites be tasked with choosing winners and losers in the marketplace of ideas, and to impose quasi-criminal sanctions on poor patients is to enter a decidedly dictatorial dimension. “Bad actor” is a legal term of art, and should be left to the jurisdiction of a court of law or other legislatively-authorized tribunal. That’s how things work in a democracy.

On the other hand, authoritarian regimes censor whatever speech they see fit, arbitrarily and without explanation. As it pertains to crowdfunding sites, what we absolutely do not need is unelected and unappointed “experts’” selling misplaced fears.

The question that should be asked is why do the SCT critics fear the agency of the people? Is the notion that people can make their own medical decisions – and accept the risks of those decisions – without “expert” stewardship, consultation or approval such a terrifying prospect?

Ultimately, this “purge and censor” line of argument represents a slippery slope that is distinctly anti-democratic. And at the bottom of the slope, are piled the bodies of the sick, whose desperation is fueled by the abject failures of mainstream medicine.

Equally disturbing is the fact that stem cell censorship on fundraising platforms would be a clear and unmistakable attack on the poor. Poor people are the ones who need to raise money, not the wealthy. The average person doesn’t have the finances of a star athlete like Max Scherzer or a celebrity actress like Selma Blair to get stem cell treatment. Instead, they have to rely on the generosity of others, a generosity that crowdfunding sites facilitate. To censor SCT fundraising is to not only censor a voice, but a livelihood, and maybe even a life itself. Poor people should not be punished for being poor.

Does Dr. Montague really expect GoFundMe and other sites to establish their own internal ethics boards and become the online sentinels of poor people’s health? There is no defensible or rational justification for preventing chronically ill poor people from raising the money they need to save their own lives.

Online Censorship Increasing

Unfortunately, online censorship of alternative health information is not new. In fact, it’s increasing. Facebook recently deleted dozens of alternative health pages without any notice or explanation. Some, such as Natural Cures Not Medicine and Just Natural Medicine, had millions of followers.

GreenMedInfo was kicked off Pinterest for violating its “misinformation policy” which bans “false cures” for chronic illnesses. And who helps Pinterest determine what health advice is false?

“We rely on information from nationally and internationally recognized institutions, including the CDC and WHO, to help us determine if content violates these guidelines,” Pinterest explained in an email.

Recent changes to Google’s Broad Core Algorithms have also suppressed search results for alternative medical information. As a consequence, hundreds of health websites have experienced drastic drops in traffic, including Pain News Network. One website, owned by alternative health advocate Dr. Joseph Mercola, lost about 99% of its traffic.

“Big Tech has joined the movement, bringing in a global concentration of wealth to eliminate competition and critical voices,” Mercola warned. “This year, we’ve seen an unprecedented push to implement censorship across all online platforms, making it increasingly difficult to obtain and share crucial information about health topics.”

“We’ve seen an unprecedented push to implement censorship across all online platforms, making it increasingly difficult to obtain and share crucial information about health topics.”

— Dr. Joseph Mercola

Even Wikipedia, which relies on open source editing for its content, has succumbed to the “deletionism” of alternative health information.

“We believe that organised skeptic groups are actively targeting Wikipedia articles that promote natural, non-drug therapies with which they disagree,” says the Alliance for Natural Health. “The new trick of these editors is to rewrite or entirely remove pertinent information from such articles or, worse still, delete entire articles altogether.”

It now appears that stem cell therapy is the next hooded subject to be escorted into the Star Chamber of deletionism. The call for fundraising censorship is distinctly ant-human, and denies the most essential and primordial of human instincts – to assist a fellow human being in their time of need.

It is not the place of GoFundMe or any other fundraising site to police people’s medical choices. GoFundMe, your core principles are turning “compassion into action” and the sharing of people’s stories “far and wide.” Please do not capitulate to the SCT bullies.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Government Grown Cannabis May Be Harming Research

By Roger Chriss, PNN Columnist

Physician researcher Sue Sisley, MD, has filed suit against the federal government over the quality of cannabis provided for her study on post-traumatic stress disorder. Sisley claims that the cannabis supplied by the DEA-sanctioned facility at the University of Mississippi is “suboptimal.”

Sisley told Green Entrepreneur that the DEA provided "standardized green powder that is just cannabis ground up.” She also said that the plants were moldy and contained sticks and seeds. 

Sisley is not the first researcher to say government cannabis intended for research is not the same as the cannabis available in dispensaries. This of course poses a key question: What is research cannabis?

Cannabis is a plant. Specifically, cannabis is the genus of a plant that includes the species C. sativa, C. indica, and C. ruderalis. There is still dispute if C. ruderalis should be included with C. sativa, or if all three species should be considered a single species, C. sativa. 

There is no precise pharmacological definition of medical cannabis. There is no agreed-upon level of THC, CBD, or other cannabinoids, and no accepted terpene profile. In dispensaries, cannabis comes in a large variety of strains used in a wide range of products. 

There is poor consistency among strains. Leafly recently attempted to measure the reliability of cannabis strains and found that even the most reliable ones were far from consistent at the levels necessary for clinical research.

Moreover, cannabis is a moving target. Because it is a commercial product often intended for nonmedical use, it is subject to a variety of market forces involving its various psychogenic effects. And new strains are introduced regularly. 

Further, cannabis products are consumed in many different ways, such as smoking, vaporizing, ingesting and through the skin . The bioavailability of cannabis varies significantly by route of consumption because of different absorption levels and metabolism. So whatever research cannabis is used would have to be specified by strain, amount and route of administration. 

For research purposes, that requires precise information. But as Genetic Engineering & Biotechnology News reported, medical cannabis comes in so many forms and has so many different uses that it presents a "unique challenge to cannabis testing laboratories." No existing test provides a good model on how to proceed.

In other words, there is no clear definition of research cannabis and there is no practical way to reliably test commercial strains with a consistency adequate for clinical studies. 

This means the definition of research cannabis is arbitrary. Researchers and advocates keep adjusting the definition or questioning the quality to explain away poor outcomes. According to Microscopes and Machines, when Dr. Sisley's PTSD study concluded, she unblinded the data and quickly came to realize the quality of cannabis provided by the University of Mississippi "had negatively affected the study’s efficacy data.”

But we cannot define research cannabis as the form of cannabis that only gives the results we were hoping for. This would be circular and self-justifying. It would also be self-defeating since we’d never know what, if anything, cannabis has to offer. 

Cannabis is a plant, not a laboratory-synthesized chemical being turned into a USP-grade pharmaceutical. As Jonathan Stea wrote in Scientific American,“it is best to conceptualize cannabis as a chemical soup with over 500 ingredients that can be served in countless different ways.”

This means that researchers will need to define their cannabis before starting a study. And the U.S. government will need to provide such cannabis. Fortunately, the National Institutes of Health is responding by producing more varieties of cannabis.

A more favorable legal landscape would also help. There may not be any “research cannabis” per se, but cannabis is certainly worth researching. 

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.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Don’t Add to My Pain

By Mia Maysack, PNN Columnist

This month I celebrate the anniversary of finally getting a fibromyalgia diagnosis, after years of fighting to “earn” it. To my lifelong course of chronic migraine was added a heaping side dish of a nerve disorder.

Intractable pain is a constant state of being for me, whether I use essential oils, think positive, drink pickle juice for 40 days and nights, or even if someone belittles, disbelieves, mocks or minimizes it.    

People often say things like "I wouldn't be able to make it” if their head hurt like mine does every day. For many, there's no possible way to imagine what it is like, but I'm finding that those who cannot relate at all often have the most opinions about it.

Others wonder how I've been able to accomplish what I have while under the persistent weight of brain discomfort. The answer is simple: Because I've had no other choice!

When not entirely incapacitated, head pain for me has been managed with a grateful attitude and a mind over matter approach. Unfortunately, when navigating matters of the physical body, more restrictions apply.  Neither deep breaths nor the tapping of my ruby red slippers will get me up or down the stairs when I'm unable to walk. 

Many around me have taken all of this personally, because the extent of the hardships I face have left me trapped behind closed doors more than ever. 

Instead of stopping by or reaching out to check in, entire relationships have changed -- primarily because my ailments have yet to be acknowledged, let alone respected.

Only recently did others finally begin to grasp the concept of my migraine and cluster headaches.

But wrapping their minds around something else? Especially when I lack the energy and desire to continually attempt to justify or explain? Forget about it. 

One thing about me is that I rarely ever complain. I'm known to seek out silver linings and hand the light I find over to the next person in need. I count my blessings on a regular basis and never lose sight as to how much worse things could be or how they can change in the blink of an eye.

So, when attempting to bare my soul while being met with judgment, doubt, questioning or just flat out disregarded, I wonder if those who respond that way ever stop to reflect. Shifting blame toward me or my conditions for our lack of fellowship or communication doesn’t help the relationship.   

Not long ago I was out at a dinner, constantly having to shift in the chair or get up to stand, while repeatedly being reminded what we're conversing about due to brain fog. All the while my head is banging and I can barely eat because the nausea from attempting to ignore everything else was heightening.   

The dear one I'm out with mentions another friend who endures similar circumstances. He proceeds to explain how he's had to carry this person out of places and into their home due to the extent of their fatigue. Hearing this tears me up because I can literally feel for them.  

But instead of using this opportunity to bond, my emotion was met with ridicule: "You are SO sensitive! I cannot talk about ANYTHING with you!"  

It felt like insult to injury, that they'd demonstrate compassion for another but then put me down.   

Before that, someone else I love labeled my chronic pain as a "placebo effect." More recently, even after discussing my disability hearing, a friend wondered if I had a gym membership because they didn’t want to work out alone.  

Not that it is blasphemous to bring up the topic of exercise, but it showed a lack of empathy. If I am in need of using a cane, not always able to drive, experience muscle failure and soreness to the touch, what about that signifies my readiness to lift weights or hop on a treadmill?

I used to go out dancing regularly, but the last time was about 24 months ago for an ex co-worker's bachelorette party -- whose actual wedding I ended up missing because of all this. Another homie of mine hasn't replied to me since I'd been forced to cancel attending her kid’s birthday party at the last minute.  

Quite honestly, if I keep in contact with just about anyone, it's because I initiate the connection. Many have flat out stopped talking to me altogether because my consistent need for self-care is an inconvenience for them.  

What they don't know is that all of this is so real. The other day, I purposefully went outside in the rain to pre-shower, because with Mother Nature's help the chore felt slightly less daunting. 

Having been dealt this hand and then being left to cope on your own has a way of demonstrating the extent of one’s strength they may not have realized they had. I am thankful for everything that broke me because that’s what I am made of.

I now declare unapologetically that all of this has forced me to change. Nothing is welcome in my life that adds more hurt or disrupts my peace. My hope is that everyone reading this reaches the same conclusion and thereby a level of freedom.    

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

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Are You Paying Too Much for Pregabalin?

By Pat Anson, PNN Editor

It didn’t take long for cheaper generic versions of pregabalin to take a bite out of Pfizer’s monopoly of Lyrica, a drug widely used to treat fibromyalgia, diabetic neuropathy and other types of chronic pain.

Last month the U.S. Food and Drug Administration gave approval to rival drug makers to begin selling generic pregabalin after Pfizer’s patent on Lyrica expired. According to FiercePharma, Pfizer lost about a third of the market for pregabalin to 16 competitors by the end of July.  

It’s not hard to see why. According to Healthcare Bluebook, a 60-day supply of 75mg Lyrica sells for a “fair price” of $472. That compares to generic versions that sell for about $28.

“The price that most patients pay is set by insurers. The cost difference for patients between brand-name Lyrica and generic pregabalin may vary depending on the patients’ insurance plan, the state in which their prescription is filled, or the pharmacy where they pick up their prescription,” said Steven Danehy, a Pfizer spokesman.

As of August 9, Lyrica still had about 43% of the market for pregabalin, but that’s likely to change as patients, doctors and insurers became more aware of the significant difference in price.

Pregabalin is approved by the FDA for the treatment of pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy. It is also commonly prescribed "off label" for other types of chronic pain.

Pregabalin is a Schedule V controlled substance, which means it has a low potential for abuse. In recent years, however, there is growing concern that pregabalin and its sister drug gabapentin (Neurontin) are being abused and overprescribed.

The drugs, which belong to a class of nerve medication called gabapentinoids, were originally developed to treat epilepsy, not pain. Prescriptions for gabapentinoids have tripled over the past 15 years as more doctors prescribed them as “safer” alternatives to opioids.

Deaths involving gabapentinoids have increased in the UK, Australia and Canada, where some addicts have learned the drugs can heighten the euphoric effect of heroin and other opioids. The drugs were recently classified as controlled substances in the UK.

Study: Virtual Reality Can Relieve Severe Chronic Pain

By Pat Anson, PNN Editor

Therapeutic virtual reality (VR) may finally be on the verge of going mainstream. For the first time, research has shown that VR can help relieve a variety of pain conditions and is most effective for severe chronic pain.

 "I believe that one day soon VR will be part of every doctor's tool kit for pain management," says Brennan Spiegel, MD, director of Health Service Research at Cedars-Sinai Medical Center in Los Angeles.

Spiegel is lead author of a new study published in PLOS ONE, which looked at the effectiveness of VR in 120 hospitalized adult patients suffering from neurological, orthopedic, gastrointestinal or cancer pain. All of the patients were being treated with opioid medication and had a pain score of at least three on a 1 to 10 pain scale.

“There’s been decades of research testing VR in highly controlled environments — university laboratories, the psychology department and so on,” Brennan told MobiHealthNews. “This study is really letting VR free and seeing what happens. What I mean by that is it’s a pragmatic study where we didn’t want to control every single element of the study, but literally just see [what would happen] if we were to give it to a broad range of people in the hospital with pain; how would it do compared to a control condition already available in the hospital?”

Half of the patients were given VR goggles with a variety of relaxing and meditative experiences to choose from. They were advised to use the headsets three times a day for 10 minutes — and as needed for breakthrough pain – for three days.

The other participants were instructed to tune their hospital room TVs to a health and wellness channel that offered programs on guided-relaxation, yoga and meditation.

Several times a day, nurses asked all the patients to rate their pain on the pain scale.

The study found that on-demand use of VR resulted in a small but statistically significant improvement in pain scores compared to the TV group, with patients in the VR group averaging 1.7 points lower on the pain scale. VR patients with the most severe baseline pain of 7 or more reduced their pain scores three points lower than the TV group.

"This is our largest and most ambitious VR study to date," Spiegel said. "Our results support previous research that VR can meaningfully reduce pain using a nonaddictive, drug-free treatment for people experience a range of different pain conditions."

In the previous study, patients who watched a 15-minute nature video had a 13% drop in their pain scores, while patients who played an animated game had a 24% decline.

Spiegel says the current study showed that VR can do more than just distract the mind from pain, but may even block pain signals from reaching the brain by overwhelming the brain with visual and audio stimulation.  

Several patients found VR so helpful in managing their pain that they now use it regularly at home. One of them is 70-year old Joseph Norris, a retired Air Force lieutenant colonel, who suffers from chronic pain in his spine, back and hips. Norris started using VR six months ago, and today uses his VR headset once a week to help relax and distract. 

"VR is a tool I use to successfully divert attention away from my pain, and it helps me reinforce my breathing pattern," he said.

There remains a great deal of skepticism about VR, particularly among older patients. Spiegel and his colleagues evaluated nearly 600 patients for the study, but many chose not to participate.

“Patients expressed varying degrees of skepticism, fear, sense of vulnerability, concern regarding psychological consequences, or simply not wanting to be bothered by using the equipment. We believe it is important for the digital health community to recognize that despite the great promise of health technology, clinical realities can undermine expectations,” he wrote.    

Spiegel and his research team are currently involved in a study following patients using VR in their homes for 60 days.

Is Ketamine an Opioid?

By Pat Anson, PNN Editor

A drug used to treat depression and pain is being touted as possible solution to the opioid crisis.

This week a South Carolina drug maker said it would partner with a medical device company to sell ketamine in take home medication bags that can be administered by an ambulatory pain pump. The idea is to give patients recovering from surgery a safer alternative to opioids.

“We are proud to partner with InfuTronix Solutions to deliver opioid-free pain medication to patients across the country,” Nephron Pharmaceuticals CEO Lou Kennedy said in a statement. “The overuse of opioids is a crisis in America. Non-narcotic pain management is a cost-saving way that companies like ours can help save lives.”

Non-narcotic? Opioid-free?

That’s not what a team of researchers at Stanford University concluded last year after studying how ketamine works in the brain. In a small clinical study, they gave a dozen patients diagnosed with depression a combination of ketamine and naltrexone – an opioid-receptor blocker. To their surprise, naltrexone stopped ketamine from working as an antidepressant.

In effect, the researchers discovered that ketamine works just like oxycodone, hydrocodone and other painkillers – by activating opioid receptors in the brain. 

“Everything that I was taught, and everything that I’ve always taught my students — all of the evidence supports the fact that ketamine is not an opioid,” said lead author Boris Heifets, MD, a clinical assistant professor of anesthesiology, perioperative and pain medicine. “I was really surprised at the results.”

“And the results were so clear that we ended the study early to avoid exposing additional patients to the ineffective combination treatment,” said co-lead author Nolan Williams, MD, a clinical assistant professor of psychiatry and behavioral science.

The Stanford research, published in The American Journal of Psychiatry, caught psychiatrists and pain management experts by surprise. Some urged caution about the long-term use of ketamine until more can be learned about potential side effects such as addiction. Some depressed patients taken off ketamine have shown signs of withdrawal and became suicidal.

“Given the rapid relapse and potential suicide risk, it is hard to know what to recommend to clinicians. Should they really continue to use the agent beyond an acute course? For how long? In whom?” Alan Schatzberg, MD, a Stanford professor of psychiatry and behavioral sciences, warned in a commentary. “The drug’s opioid properties need to be considered when considering how best to use it.”

‘A Black Eye to Ketamine’

Talk like that has given ketamine a bad rap, according to experts at Johns Hopkins University School of Medicine. They’ve published a commentary of their own, defending the use of ketamine as a necessary treatment for depression that doesn’t respond to typical antidepressants.

“A (Stanford) study done late last year delivered a black eye to ketamine, and as a result of the coverage, there was a wholesale acceptance by both potential patients and physicians that ketamine is an opioid,” says Adam Kaplin, MD, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins.

“This is most worrisome if people continue to think this way, particularly in the wake of the opioid epidemic; clinicians won’t refer patients for a treatment, despite that it has been shown to be incredibly effective for many patients with treatment-resistant depression.”

Kaplin says there is ample evidence that ketamine sticks to NMDA receptors in the brain that are involved in learning and memory. Because these NMDA receptors are found together with opioid receptors, Kaplin says it’s no surprise that the can meddle with one another, like interference picked up on a phone call or static on the radio.

“This interference and cross-talk does not mean that ketamine is an opioid, and to wrongly label it as such could eventually keep patients from essential antidepressant medications that could make a huge difference in their quality of life,” said Kaplin, who plans on opening a ketamine clinic.

The debate over whether ketamine is an opioid comes at a time when its use is expanding.  Ketamine was approved by the FDA in 1970 solely as a surgical anesthetic to be taken intravenously or by injection. But a growing number of clinics now offer off-label infusions of ketamine to treat depression, post-traumatic stress disorder and difficult chronic pain conditions such as Complex Regional Pain Syndrome (CRPS).

Demand has grown so much there are reports of ketamine shortages. Although ketamine itself is inexpensive, the infusions can cost several hundred dollars and are not covered by insurance.

Ketamine Nasal Spray

Not until this year did the Food and Drug Administration approve the use of ketamine to treat depression, when it okayed a nasal spray (Spravato) made by Janssen Pharmaceuticals that contains a ketamine compound.

The FDA approved Spravato even though 2 out of 3 short term trials failed to prove its effectiveness. The spray was effective in a longer trial, but only when taken with a conventional antidepressant.

Because of the risk of abuse and side effects, Spravato can only be administered in a doctor’s office, where patients can be observed for two hours after taking a dose. A single dose will cost about $900.

The FDA has called the herbal supplement kratom an opioid because it acts on opioid receptors, but the agency has not taken that step with ketamine. Given current attitudes about opioids, it’s fair to say the FDA would have never approved Spravato if it was considered an opiate.

In addition to its medical uses, ketamine is used as a recreational party drug – known as “Special K” -- because it can cause hallucinations and intense dream-like states.

Whether taken to get high or to treat pain and depression, it’s clear that ketamine is a potent drug that has both harms and benefits. And experts say it needs to be viewed with caution until we know with more certainty how it works.

“Unfortunately, when one approaches ketamine as another antidepressant rather than a drug of abuse, this type of trap is easy to fall into, and in the end, such mistakes can be catastrophic,” Schatzberg said in his commentary. “We have witnessed four decades of supposedly new and safer opioids that have turned out often to be, if anything, even more abusable and lethal."

Some Pharmacies Won’t Sell Suboxone, But Street Dealers Do

By Nina Feldman, WHYY

Louis Morano knew what he needed, and he knew where to get it.

He made his way to a mobile medical clinic parked on a corner of Philadelphia’s Kensington neighborhood, in the geographical heart of the city’s overdose crisis. People call it “the bupe bus.”

Buprenorphine is a drug that curbs cravings and treats the symptoms of withdrawal from opioid addiction. One of the common brand name drugs that contains it, Suboxone, blends buprenorphine with naloxone. Combined with cognitive behavioral therapy, it is one of the three FDA-approved medicines considered the gold standard for opioid-addiction treatment.

Morano had tried Suboxone before — he had purchased some from a street dealer and had used it to get through his workday, when he couldn’t use heroin. It kept the misery of withdrawal sickness at bay.

Morano, 29, has done seven stints in rehab for opioid addiction in the past 15 years. So he had a sense of how the drug would make him feel. He’d always sort of thought of it as a crutch. But after a slip following his latest stint in rehab, he said, he committed to recovery.

“I can’t do this anymore, and I need something,” Morano said.

The bupe bus — a project of Prevention Point Philadelphia, the city’s only syringe exchange program — is part of Philadelphia’s efforts to expand access to this particular form of medication-assisted treatment, known as MAT, for opioid addiction.

Morano was first in line at the mobile clinic. When the doors of the bus heaved open, Dr. Ben Cocchiaro waved Morano inside, where they squeezed into a tiny exam room.

Cocchiaro and Morano discussed how buprenorphine might help Morano’s recovery succeed this time, and whether he’d be open to seeing a therapist. Cocchiaro gave Morano instructions on how to take the medication, and then called a pharmacy to authorize a prescription.

Barriers to Treatment

To date, much of the research on barriers to buprenorphine access has focused on the fact that too few medical providers are certified to write the prescriptions. According to federal law, doctors must apply for a special waiver from the Substance Abuse and Mental Health Services Administration, or SAMHSA, to prescribe buprenorphine. To get the waiver, a doctor must undergo eight hours of training — and can prescribe the drug to a maximum of 30 patients at a time, to start. Given these constraints, many doctors don’t bother.

But pharmacists are also a part of the problem. Because they fill the prescriptions, pharmacists are the gatekeepers for the drug, and not all of them are willing to take on that role. Increasing pharmacists’ involvement in distributing buprenorphine might be just as important as persuading more doctors to prescribe it, according to Dan Ventricelli of the Philadelphia College of Pharmacy.

“We can write a bunch of prescriptions for people,” he said. “But if they don’t have a pharmacy and a pharmacist that’s willing to fill that medication for them, fill it consistently and have an open conversation with that patient throughout that treatment process, then we may end up with a bottleneck at the community pharmacy.”

Just a few blocks from the bupe bus in Kensington, Richard Ost owns an independent pharmacy. He said his store was one of the first in the neighborhood to stock buprenorphine. But after a while, Ost started noticing that people were not using the medication as directed — they were selling it instead.

Buprenorphine acts as a partial opioid agonist, which means it’s a low-grade opioid. When taken in pill or tablet form, it’s unlikely to cause the same feelings of euphoria as heroin would, but it might if it were dissolved and injected. Many people buy it on the street for the same reason Morano did: to keep from going into withdrawal between injecting heroin or fentanyl. Others buy it to try to quit using on their own.

“We started seeing people do it in our store in front of us,” said Ost. He said it’s unethical to dispense a prescription if a patient turns around and sells it illegally, rather than use it. “Once we saw that with a patient, we terminated them as a patient.”

Ost explained that the illegal market for Suboxone also meant customers trying to stay sober were being continually targeted and tempted.

“So if we were having a lot of people in recovery coming out of our stores, the people who were dealing illicit drugs knew that, and they would be there to talk to them and they would say, ‘Well, I’ll give you this’ or ‘I’ll give you that,’ or ‘I’ll buy your Suboxone’ or ‘I’ll trade you for this.’”

Ost said that eventually his staff didn’t feel safe, and that neither did the customers. He understands the value of bupe but said it just wasn’t worth it. He mostly has stopped carrying it.

Even those pharmacies that aim to stock buprenorphine can run into problems. Limits set by wholesalers require pharmacies to order the drug in small, frequent batches. Though pharmacies can apply for exemptions to order more at a time, or to have a higher percentage of their total stock consist of controlled substances, doing so invites a higher level of scrutiny from the wholesaler and, in turn, the Drug Enforcement Administration.

Another issue is that doctors and pharmacists receive different education about how long buprenorphine should be prescribed before tapering a patient off it. Many medical providers might prescribe the drug for long-term treatment, based on recent SAMHSA guidelines, while pharmacists may view longer courses of treatment as posing the risk of long-term dependency.

“It’s not even that they’re on different pages,” said Ventricelli of the College of Pharmacy. “It’s that they’re reading completely different books.”

If a patient going through withdrawal can’t get buprenorphine quickly, the stakes are high. Silvana Mazzella, associate executive director at Prevention Point, said that when it’s not available, patients are more likely to turn back to heroin or fentanyl.

“We’re in a situation where if you are in withdrawal, you’re sick, you need to get well, you want help today, and if you can’t get it through medication-assisted treatment, unfortunately you will find it a block away, very quickly, and very cheaply,” she said.

Doctors with Prevention Point have found a pharmacy near the bupe bus that will reliably dispense buprenorphine to their Philadelphia patients. It’s a neighborhood branch of a local chain, called the Pharmacy of America.

The head pharmacist, Anthony Shirley, said he’s comfortable filling the scripts because he trusts that the doctors at Prevention Point will write prescriptions only for patients who need the medication. He has heard firsthand from patients who say buprenorphine saved their lives.

“That’s something you can’t really put a price tag on,” Shirley said. For him, the calculation is simple: His store is in an area where many people need buprenorphine. That means it’s his job to get it to them.

This story is part of a partnership that includes WHYY, NPR and Kaiser Health News. KHN is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Surgeons Reduce Rx Opioids Without Increasing Pain

By Pat Anson, PNN Editor

Surgeons in Michigan have reduced the amount of opioid medication prescribed to patients recovering from common operations by nearly a third -- without causing patients to feel more postoperative pain.

In a new research letter published in the New England Journal of Medicine, a team from the Michigan Opioid Prescribing Engagement Network (OPEN) reported on the results of a statewide effort to get surgical teams to follow prescribing guidelines for postoperative pain.

In just one year, surgeons at 43 Michigan hospitals reduced the number of opioid pills prescribed to patients after nine common operations, from an average of 26 pills per patient to an average of 18.

The surgeries included minor hernia repair, appendix and gallbladder removal, and hysterectomies. Most were minimally invasive laparoscopic surgeries.

The ratings patients gave for their post-surgical pain and satisfaction didn't change from the ratings given by patients treated in the six months before opioids were reduced.

Researchers say patients only took about half the opioids prescribed to them, even as the prescription sizes shrank. They attribute this to improved counseling about pain expectations and non-opioid pain control options.

"The success of the statewide effort suggests an opportunity for other states to build on Michigan's experience, and room for even further reductions in prescription size," said Michael Englesbe, MD, a University of Michigan surgery professor. "At the same time, we need to make sure that patients also know how to safely dispose of any leftover opioids they don't take."

The study involved over 11,700 patients who had operations at hospitals participating in the Michigan Surgical Quality Collaborative. About half of the patients also filled out surveys sent to their homes after their operations, asking about their pain, satisfaction and opioid use after surgery.

The Michigan-OPEN team has been working since 2016 to reduce opioid prescribing and quantify the appropriate number of pills patients should take. Their research led to the the development of new guidelines that were first tested on gallbladder surgery patients before being expanded to other types of surgery.

Some hospitals have stopped giving opioids to surgical patients. Patients at Cleveland Clinic Akron General Hospital get acetaminophen, gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs) to manage their pain before and after colorectal operations – and their surgeons say the treatment results in better patient outcomes

It’s a common misconception that many patients become addicted to opioids after surgery. A 2016 Canadian study, for example, found that long term opioid use after surgery is rare, with less than one percent of older adults still taking opioid pain medication a year after major elective surgery.

Another large study in the British Medical Journal found similar results. Only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Another fallacy is that leftover pain medication is often stolen, sold or given away. The DEA says less than one percent of legally prescribed opioids are diverted.

Panel Recommends All Adults Be Screened for Illicit Drug Use

By Pat Anson, PNN Editor

The next time you visit a doctor, he or she may want to know more than what medications you take or if you consume alcohol.

An influential national panel of health experts is recommending for the first time that U.S. doctors screen all adult patients for illicit drug use, including the nonmedical use of opioids and other prescription drugs. “Nonmedical” means the use of a friend’s or relative’s prescription or buying medications off the street. It can also mean using a legal medication more frequently or in higher doses than prescribed.

The U.S. Preventive Services Task Force concluded with “moderate certainty” that screening for illicit drug use would be beneficial because it would lead to a more accurate diagnosis and treatment for substance abuse.

Screening typically involves questions about drug use and frequency. This can include questions on routine intake forms or asking patients directly when they visit with a healthcare provider. Screening does not include drug testing, although nothing would stop a doctor from ordering such tests.

“Illicit drug use can have a devastating impact on individuals and families,” said task force co-vice chair Karina Davidson, PhD, a professor of behavioral medicine at the Zucker School of Medicine at Hofstra University. “Clinicians can help by screening their adult patients and connecting people who use illicit drugs to the care they need to get better.”

About 11.5% of Americans age 18 years or older reported using cannabis or illicit drugs in a national survey. Illicit drug use is more common in young adults ages 18 to 25 years (24.2%) than in older adults (9.5%).  About one in five illicit drug users reported the nonmedical use of psychotherapeutic drugs, including opioids, pain relievers, or other medications. Less than 8% reported using cocaine, hallucinogens, or inhalants.

Although illicit drug use is relatively common among adolescents (7.9%) aged 12 to 17, the task force said there was not enough evidence to support screening for Americans under the age of 18.

“We want to help prevent illicit drug use in teens, so we’re calling for more research on the benefits of screening,” said task force member Carol Mangione, MD, chief of general internal medicine at the David Geffen School of Medicine at UCLA. “Clinicians should continue to use their professional judgement to determine what’s best for their teen patients.”

The task force’s draft report is available for public comment through September 9. After the task force reviews the comments, it will issue a final report. The panel’s recommendations are not mandatory for healthcare providers, but like many federal guidelines – such as the 2016 CDC opioid guideline -- they could be adopted as a “standard of care” by medical associations and healthcare systems.  Some already recommend that providers routinely screen their patients about illicit drug use.

AG’s Call for Weakening of HIPAA Laws

Federal laws that have long protected the privacy of patients undergoing addiction treatment may also be changing. The National Association of Attorneys General wants Congress to end regulations that prevent doctors from sharing information about their patients’ addiction treatment histories.

In a letter recently sent to congressional leaders, 39 state attorneys general called on Congress to “replace the cumbersome, out-of-date, privacy rules” contained in the Health Insurance Portability and Accountability Act (HIPAA). One section of the law – known as 42 CFR Part 2 – sets strict rules about disclosing patient records for substance abuse treatment.

“These privacy rules were created more than 40 years ago in a time of intense stigma surrounding substance use disorder treatment. They were created to assure patients that they would not face adverse legal or civil consequences when seeking treatment by protecting confidentiality of substance use disorder patient records,” the AG’s said.

“Unfortunately, they now serve to perpetuate that stigma, as the principle underlying these rules is that substance use disorder treatment is shameful and records of it should be withheld from other treatment providers in ways that we do not withhold records of treatment of other chronic diseases. While maintaining confidentiality is imperative to encouraging individuals to seek and obtain treatment, the inability to share records among providers can burden coordination of care, potentially resulting in harm to the patient.”

Two bills under consideration in Congress, the Overdose Prevention and Patient Safety Act and the Protecting Jessica Grubb’s Legacy Act would amend 42 CFR Part 2 to allow for addiction treatment records to be shared. The bills have been endorsed by over 40 national healthcare organizations, including the American Hospital Association, the American Psychiatric Association, and the American Society of Addiction Medicine.

Study: Prescription Drug Databases Overestimate Opioid Misuse

By Pat Anson, PNN Editor

Prescription drug monitoring has long been seen as the gold standard for tracking the opioid crisis. Patients who fill an opioid prescription for more than three months are considered long-term users with a higher risk of misuse, addiction and overdose. Many pharmacy chains assign a “risk score” to these patients and their doctors could even get a warning letter from the government.

But in a small study of emergency room patients, Canadian researchers found the risk of opioid misuse by long-term users is small and one out of five patients who fill opioid prescriptions don’t even use them. Their findings suggest that prescription databases alone are a poor way to measure opioid misuse.

“The rate of long‐term opioid use reported by filled prescription database studies should not be used as a surrogate for opioid misuse,” said lead author Raoul Daoust, MD, a professor and researcher in the Department of Family Medicine and Emergency Medicine at the University of Montreal.

Daoust and his colleagues surveyed 524 patients who were discharged from a hospital emergency department (ED) with an opioid prescription for acute pain. Instead of just relying on a database to track their prescriptions, the researchers asked the patients about their opioid use.

Three months after discharge, only 47 patients – about 9 percent – said they were still using opioids. Of those, 72% said they used opioids to treat their initial pain and 19% were using the drugs to treat a new pain condition.

The remaining four patients said they used opioids for another reason, suggesting possible misuse. That’s less than one percent (0.8%) of the original 524 patients.

“Within the limit of our study, our results suggest that the risk of long‐term opioid use for reasons other than pain is low for ED discharged patients with an opioid prescription treating an acute pain condition,” Daoust reported in the journal Academic Emergency Medicine.

Daoust’s findings are controversial because they throw into question the widely accepted theory that all opioid prescribing is risky, whether it’s for chronic or acute pain. The methodology used in his study was questioned by one critic.

"Emergency physicians should not be reassured by the authors' findings. The lack of a denominator, poor response rate (56%), and applied definition of misuse are significant limitations,” said Gail D'Onofrio, MD, a professor of emergency medicine and chair in the department of emergency medicine at Yale University.

D'Onofrio cites a 2017 CDC study, which found that the probability of long-term opioid use increases sharply after the first few days of treatment.

“Transitions from acute to long-term therapy can begin to occur quickly: the chances of chronic use begin to increase after the third day supplied and rise rapidly thereafter,” CDC researchers warned.

But that analysis is based solely on the number of opioid prescriptions – not actual opioid use. And Daoust found that studies like that are a poor way to measure risk.

“These studies used filled prescriptions databases that could overestimate opioid use since not all patients filling an opioid prescription consumed them. As a case in point, in this study, 21% of patients who filled their opioid prescription after the initial ED visit did not consume them,” Daoust reported.

What is the risk of long-term opioid use after an emergency room visit? In a large 2017 study by the Mayo Clinic, only about 1 percent of ER patients given an opioid prescription progressed to long term use – similar to what Daoust found.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

A 2018 study also questioned the value of prescription drug monitoring programs (PDMPs) which have long been promoted as critical tools in the fight against opioid abuse. The study found little evidence that PDMPs are reducing overdoses and that they may lead to unintended consequences such as patients turning to street drugs for pain relief.