New Non-Opioid Drug Effective in Treating Low Back Pain

By Pat Anson, PNN Editor

Pfizer and Eli Lilly have announced positive results from a large Phase 3 study evaluating an experimental non-opioid pain reliever as a treatment for chronic low back pain.

Patients receiving 10 mg injections of tanezumab showed statistically significant improvement in back pain at 16 weeks compared to placebo. A lower dose of tanezumab 5 mg was not as effective. Over 1,800 people with chronic low back pain in North America, Europe and Asia participated in the study.

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

"This study demonstrates the potential of tanezumab to treat individuals suffering from moderate-to-severe chronic low back pain who have been unable to achieve relief with currently available medicines," said Ken Verburg, Pfizer’s tanezumab development team leader.

“This is one of the longest studies conducted to date in chronic low back pain. We look forward to further analyzing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain."

Pizer and Eli Lilly have also reported positive findings in evaluating tanezumab for the treatment of osteoarthritis. The Food and Drug Administration granted “fast track” designation to tanezumab in 2017 to help speed its development.

Tanezumab has a history of safety concerns. Clinical studies were halted in 2010 after Pfizer reported some osteoarthritis patients receiving the drug had worse symptoms and needed joint replacement surgery. Another safety issue arose in 2012 when tanezumab caused adverse changes in the nervous system of animals.  Most clinical studies of tanezumab did not resume until 2015.

In the current study, rapidly progressive osteoarthritis (RPOA) was observed in 1.4 percent of patients receiving tanezumab and 0.1 percent of patients in the other treatment groups. Joint fractures and total joint replacements were experienced in 0.4 percent and 0.7 percent of tanezumab-treated patients, respectively, while none were observed in the other treatment groups.

In addition to back pain, the ongoing Phase 3 program for tanezumab includes studies in osteoarthritis pain and cancer pain due to bone metastases.

A New Psychological Treatment for Chronic Pain

By Ann Marie Gaudon, PNN Columnist

Cognitive behavioural therapy (CBT) has dominated the field of psychological treatment for chronic pain for the last three decades. Studies have shown that it is effective, yet some researchers say CBT also has its limits and could be improved upon.

As CBT treatment approaches continue to evolve, what is noteworthy is a departure from the logic of everyday thinking. “Suffering” is not seen as pathology, but rather as inherent in the human condition. We don’t want it and we don’t like it, but suffering is inescapable.

Following this principle, the utility of “normal thinking, analyzing, and problem-solving” is called into question. Our brains have evolved into powerful problem-solvers that serve very well with things are external to us. For example:

Problem: your car malfunctions and no longer starts. If you have the knowledge and skills, you find the problem and repair the car. Problem solved. If you do not have the skills, you find someone who does and repairs it for you. Problem solved.

But chronic pain is an internal problem that cannot be easily solved. No matter the effort from our powerful problem-solving brains, doctors and patients often cannot work it out. For a sufferer to spend a lifetime attempting to analyze and logically think their way to being pain-free can be a lifetime spent in futility.

Acceptance and Commitment Therapy

Newer psychological approaches such as Acceptance and Commitment Therapy (ACT) are guided by the premise that we cannot change the pain we’re left with, so let’s change our response to that pain. ACT was outlined in a 2014 article in the journal American Psychologist.

ACT differs notably from traditional CBT in method. Rather than challenging and changing thoughts, ACT seeks to reduce their influence over our behaviour. This core treatment process is called “psychological flexibility,” which is the ability to contact the present moment fully and consciously, based on what the situation affords.

In other words, we act on our long-term values rather than short term impulses, thoughts and feelings. I have a personal example of this:

“Knowing that I love to dine out and see live theatre, my partner reserved an evening of these as a surprise birthday present for me. After the reservations were made, I endured a serious back injury, which makes sitting for long periods particularly painful. He offered to cancel immediately, but I stopped him.

My thoughts told me, ‘Don’t go! You’ll be in more pain. Stay home and protect yourself!’

I applied a few of the many skills I have learned through ACT and was able to hold these thoughts lightly, and essentially not buy into them. I committed to continue with the dinner and theatre plans, and accept the pain in the service of my value of nurturing a social life. Result: my pain was not in charge -- I was.”

Why would one choose these strategies? It’s because thoughts and emotions tend to be unreliable indicators of long-term value. They ebb and flow constantly and we have little control over them. If we act based solely on them, we can lose out on experiences that bring true meaning and vitality to our lives.

In my case, I could have held onto my thoughts tightly and isolated myself at home with my pain, but instead I chose not to buy into those thoughts, to be willing to have the pain (acceptance), and commit to an experience which brought richness to my life. I knew my evening out would not reduce or eliminate my pain. I chose to do something of value to me -- the pain came along for the ride.

The catch is that unhelpful thoughts and emotions can dominate without a person even being aware of them. This results in “psychological inflexibility,” which leads to rigid, ineffective behaviour. If I let my thoughts run the show, the result would have been that I isolated myself at home with my pain and likely more suffering. Other positive behaviours and experiences would have been essentially blocked from me. No thank you.

Evidence to support ACT for chronic pain continues to grow, and its efficacy is about the same as CBT at this point. This is no small feat, considering CBT has been the gold standard for decades.

There are at least six randomized controlled trials which support the use of ACT for chronic pain. Most show ACT increases the acceptance of pain, along with improvements in anxiety, depression, and reductions in disability. This psychological flexibility significantly improves life satisfaction, disability, emotional distress and fear of movement.

It will be interesting to see future studies as ACT continues to advance and helps us find new and different ways “to act successfully in the world.”

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

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.

Should the CDC Opioid Guideline Be Revised?

By Pat Anson, PNN Editor

Carol Levy’s recent column (see “Guideline Paranoia”) drew quite a response from PNN readers, many of them offended by Carol’s contention that pain sufferers complain too often about the CDC’s 2016 opioid prescribing guideline.

“Maybe if we did not take any and all new guidelines as a frontal attack on us, maybe we would not be seen and referenced so often as a major component and cause of the opioid epidemic,” Carol wrote.

Those were fighting words to many pain sufferers who’ve been cutoff from opioid medication or had their dose reduced since the guideline came out. Dozens of patients commented on Carol’s column.

“Sounds a bit like blaming the victim for getting upset,” said Jen Saeger. “We ARE being targeted and having our medication taken away because these CDC guidelines have been taken as law. This isn’t overreacting, this is happening all over the country.”

“This woman needs to be educated about what is actually happening. We aren't overacting,” said Teresa. “Does she not know pain patients are being tapered or have completely lost their pain meds? Has she not heard of the suicides that are occurring in the chronic pain community?”

“Once these guidelines were released my pain doctor cut my medications by nearly 50% as well as many of his other chronic pain patients. He also showed me a letter from the CDC exclaiming that he was writing too many prescriptions for narcotic pain killers,” said Joe Allio. “So when they say this was a suggested guideline and not a mandate, IT'S A BIG FAT LIE!!!!! What I saw in this letter was nothing short of a threat!”

“The policymakers are the ones that need to be reminded that these are just guidelines,” wrote Vickie Tway. “You might especially want to let the DEA know this as they are running roughshod over physicians and causing those who DO want to help intractable pain patients to give up their profession for fear of being raided and facing criminal charges for doing their jobs.”

“The problem is that (doctors), pharmacies and insurance companies are using those said guidelines against chronic pain patients. Whether that's who they were intended for or not. CPP are having their meds cut back or cut off because of this hysteria and the new guidelines,” said Tracey Morales. “Until the CDC makes a statement to set this right people are going to continue suffering.”

CDC ‘Committed to Evaluating the Guideline’

PNN readers are better informed and more knowledgeable about the CDC guideline than most Americans. And they’re right when they say that the guideline was only supposed to promote a dialogue between primary care physicians and patients about the risks of opioid therapy.  The recommendations were never meant to be mandatory rules for everyone to follow, yet they’ve been widely adopted by other federal agencies, states, insurers, pharmacies and throughout the U.S. healthcare system.

Within months of the guideline’s release, CDC was warned by its own public relations consultants that “some doctors are following these guidelines as strict law” and that “pain patients who have relied on these drugs for years are now left with little to no pain management.”

In a joint letter to the CDC last year, over 200 healthcare providers warned the agency that many patients were being abandoned or forcibly tapered off opioids, and some were turning to suicide or illegal drugs to escape from their pain.

“Within a year of Guideline publication, there was evidence of widespread misapplication of some of the Guideline recommendations,” the letter warns. “These actions have led many health care providers to perceive a significant category of vulnerable patients as institutional and professional liabilities to be contained or eliminated, rather than as people needing care.”

The CDC pledged three years ago to “revisit this guideline as new evidence becomes available.”

“CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

Will the CDC keep its pledge? The agency did not immediately respond to a request for comment on what it was doing to assess the impact of guideline or whether it would be revised.

(Update: On February 28th — 9 days after we asked — the CDC sent PNN a brief statement indicating it has “several studies underway with external researchers” evaluating the impact of the guideline on opioid prescribing and patient outcomes.

“CDC is commissioning a chronic pain systematic review by the Agency for Healthcare Research & Quality (AHRQ) to determine what new scientific evidence has been released since the CDC Guideline was released in March 2016. The chronic pain systematic review is underway now,” said CDC spokesperson Courtney Lenard.

“The review will evaluate the effectiveness and comparative effectiveness of non-opioid pharmacologic therapy and pharmacologic (opioid and non-opioid) therapy for chronic pain, considering the effects on pain, function, quality of life, and adverse events.”

The statement gave no indication when the review and other studies would be completed.)

How has the guideline affected you and should it be revised? If you’re a patient or healthcare provider, you can help shape the debate by taking our survey. Either click here or on the banner above.

We’ll release the survey results on March 15th, the third anniversary of the guideline’s release.   

CDC: Opioid Prescriptions Drop in 3 of 4 U.S. Counties

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has released another study documenting how prescriptions for opioid medication have fallen dramatically in recent years. The study partially credits the CDC’s own guideline for the drop in opioid prescribing, but makes no mention of the suffering and suicides of pain patients who’ve been cut off from opioid medication.

Researchers at the CDC’s National Center for Injury Prevention and Control – which developed the agency’s controversial 2016 guideline -- looked at opioid prescribing trends nationally from 2015 to 2017.

They found significant declines in high dose opioid prescribing and in the average daily dose, which fell from 48.1 MME (morphine milligram equivalent) to 45.2 MME, a 6% decline. The guideline recommends that doses not exceed 90 MME except in rare instances.

Nearly 3 out of 4 counties experienced a reduction of 10% or more in the amount of opioids prescribed – the counties colored green in the map below. Relatively few counties, primarily in the Midwest and northern Rockies, had a 10% or more increase in opioid prescribing – counties that are marked in orange.

JAMA INTERNAL MEDICINE

“The reduction in opioid prescribing that began in 2012 has accelerated in the United States. The amount of opioids prescribed decreased an average of 10.0% annually with reductions in 74.7% of counties from 2015 to 2017,” CDC researchers reported in JAMA Internal Medicine.

“Recent reductions could be related to policies and strategies aimed at reducing inappropriate prescribing, increased awareness of the risks associated with opioids, and release of the CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. Despite reductions in prescribing, opioid overdose rates continue to increase and are driven largely by illicitly manufactured fentayl.”

A similar CDC study in 2018 also documented a decline in prescriptions, but made no effort to measure the guideline’s impact on patients and whether it had improved the quality of their pain care or worsened it.  There is only a brief acknowledgement that both studies are limited by “the inability to determine the appropriateness of opioid prescriptions” -- a belated and backhanded admission by the CDC that its guideline is built on the false premise that it knows what an appropriate dose is.

Had the CDC looked in its own Twitter feed touting the latest study, it could have found insight from patients on the guideline’s effect on the quality of pain care.

“Yea this is why my wife has been bedridden for over 2 YEARS now as her doctor does NOT BELIEVE in pain medication.  And when we call all the other practices in the area its more of the same response. Either we don't prescribe opioids or we don't take pain patients,” one poster wrote.

“Let's not forget skyrocketing suicide and patients turning to the streets for relief. Good job you now have a #OpioidCrisis of your own making,” another poster wrote.

“When the numbers of a drug are more meaningful than the human lives they help. So caught up in numerical reduction people who once had managed pain are forced to suffer or #SuicideDueToPain. I guess this makes you folks very proud, to kill off the disabled,” said another.

“And here we see the CDC touting what they think is a great thing. Ironically of course they are likely NOT tracking how many patients committed suicides after being forcibly tapered for no medical reason,” said Dave Wieland, a pain patient and advocate.

“And you can bet they are NOT tracking how many patients who had been able to work on their stable medication dosage, have now been forced to apply for disability after having their medication also taken away for no medical reason. Oh yea that's right the CDC doesn't care about those things.”

When the CDC released its guideline nearly 3 years ago, it pledged to “revisit this guideline as new evidence becomes available" and to evaluate its impact on doctors and patients.

How has the CDC guideline affected you? As the third anniversary of the guideline approaches, PNN is conducting a new survey of patients and healthcare providers. Is the guideline working as intended?

Click here to take the survey, which should only take a few minutes.

CBD Is Now Regulated and That May Be a Good Thing

By Roger Chriss, PNN Columnist

The legal status of cannabidiol (CBD) is changing. Once classified exclusively as a Schedule I drug under the Controlled Substances Act, CBD is now legal under federal law. And this means regulation.

The 2018 Farm Bill removed hemp from Schedule I. Hemp is a strain of marijuana with very low levels of THC, but high amounts of CBD.  This has opened the door to a legal market for CBD products, including food and supplements. But there’s a catch. The FDA has strict regulations about CBD being used in dietary supplements or promoted as medical treatments.

“It’s unlawful under the FD&C Act (Federal Food, Drug, and Cosmetic Act) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived,” FDA commissioner Scott Gottlieb, MD, said in a December 2018 statement.

“Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use.”

 The FDA has a FAQ page about cannabis that answers some basic questions:

"Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements? A. No."

"Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added? A. No."

The FDA has reason to be concerned. Product quality for CBD products is iffy at best. An investigation by the NBC affiliate in Miami (see “Patients Are Being Duped”) found that 20 of 35 CBD products tested had less than half the amount of CBD advertised on the label. Some samples had no CBD at all.

Other recent analyses have found THC, pesticides, synthetic cannabinoids and toxic solvents in CBD products.

Moreover, a lack of regulatory oversight has led to an abundance of false, misleading or unsubstantiated claims. A recent review of CBD in the Journal of Clinical Pharmacology found that “CBD has been touted for many ailments for which it has not been studied, and in those diseases with evaluable human data, it generally has weak or very weak evidence.”

There is a lot of research on CBD going back years. The FDA’s approval of the CBD-based drug Epidiolex for rare childhood seizure disorders and a 2018 review that found potential for treating multiple sclerosis symptoms are important indicators of CBD’s medical value. At the same time, researchers have found no benefit in treating spinal cord injury, Crohn’s disease and osteoarthritis.

Yet CBD is now being widely promoted as a wellness product, and added to everything from coffee and pastries to bath oils and mascara. So it is not surprising that the FDA is concerned that people may be duped or put at risk.

The FDA is not alone in this. The New York City Department of Health has banned CBD products from being sold in bars and restaurants. Maine, New York, and Ohio are also banning CBD edibles.

For medically complicated people with chronic illness, regulation could be beneficial. At present these patients face significant risks with CBD products. Tainted CBD may cause unexpected allergic reactions or drug interactions. And contaminated CBD could trigger a positive result on a urine drug test, a common part of pain management amid the opioid crisis. Regulatory oversight could help reduce these risks. 

The legal and regulatory landscape surrounding CBD is shifting quickly. The FDA and state government agencies are watching closely and starting to intervene. This may flush out bad actors in the CBD marketplace and improve product quality and reliability. A stable marketplace with reliable products may be a net gain for the people who stand to benefit the most from CBD.

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.

Advocating for Migraine and Headache Research

By Mia Maysack, PNN Columnist

This week I had the privilege of attending the 12th annual “Headache on the Hill” lobbying event in Washington, DC, which is organized by the Alliance for Headache Disorders Advocacy (AHDA). This was my second time being involved and I plan to attend for as many years as possible.

Headache on the Hill is a two-day engagement that began with a briefing for over 160 advocates who traveled to Washington from around the country. This is when we heard from experts and learned how to strategize, focus on what we want to achieve, and get an opportunity to engage and ask questions.  

Early the next morning we had a headache policy forum breakfast and heard from Rep. Andy Harris, MD (R-Maryland), who lives with cluster headaches and is passionate about our cause.

“If we have to drag the federal government kicking and screaming into a modern age on treatment of pain syndromes, including headache pain syndromes, migraine, cluster headaches - we'll do it and I'll be there with you every step of the way," Harris said.

After breakfast, we all joined together to venture as a group to Congress to meet with our representatives and shares our stories on the struggles we face as migraine and headache sufferers.

ALLIANCE FOR HEADACHE DISORDERS ADVOCACY

Most important is the need of more funding for research on headache disorders. Only through research do we possess a chance at ever understanding all the layers of this complex medical problem.

Headache disorders affect more than 90% of Americans and cost the economy $31 billion every year in lost productivity, yet less than 1% of the budget for the National Institutes of Health (NIH) is spent on headache and migraine research.

We are not attempting to suggest that our cause is more worthwhile than others. We're merely pointing out that we are on severely unequal ground. How is it that so many millions of Americans are enduring migraines and headaches, yet it is the least funded field of medical research? 

We know that chronic migraine is the second leading cause of global disability and cluster headache has the deserved reputation of being "the most severe pain that humans can experience." I have endured both in some form every day for almost 20 years straight.

Is there a logical reason why 59% of Americans impacted by chronic migraine who seek refuge in emergency departments receive opioid medication? Opioids can worsen the severity and frequency of migraines. Meanwhile, we have to fight for other treatments such as oxygen therapy, which has been proven to assist in decreasing cerebral blood flow and lessen the pain of cluster headaches. Oxygen is natural, has no side-effects and is non-habit forming, which are the approaches the NIH should be investing in.

Breath work and mindfulness meditation have also changed the game for me personally and I am grateful to declare that discipline in those practices has led to an overall heightened sense of awareness, which actually helps me with coping.

We've recently been fortunate enough to have several injections introduced as preventative treatments for migraine. That’s a great start -- though many of us are unable to gain proper access to these expensive treatments due to our circumstances.

The bottom line is that by showing up in D.C. and by advocating every chance we get in regular everyday life, we can make progress in raising awareness and funding for more research. Our efforts during Headache on the Hill were well received. Advocates from over 40 states attended, our meetings were empowering and there was empathy for our stories.

I am extraordinarily grateful to the members of Congress that made time to meet with us, the advocates who were alongside me for this adventure, and everyone who has or will participate in Headache of the Hill. 

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook support group, and Peace & Love Enterprises, a wellness coaching practice focused on holistic health.

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.

Health Is the Wealth We Need

By Barby Ingle, PNN Columnist

I recently came across an interesting quote on Instagram about the four types of wealth. The quote goes like this:

“There are 4 types of wealth:

1. Financial wealth (money)

2. Social wealth (status)

3. Time wealth (freedom)

4. Physical wealth (health)

Be wary of jobs that lure you in with 1 and 2, but rob you of 3 and 4.”

The quote is meant as advice for people looking for employment and the types of jobs they should seek. But I look at it from the health perspective, since that is my biggest challenge in life.  I want health wealth. Financial, social and time wealth are often dependent on our health wealth. Without health we are limited in what we can do.  

People planning to have a child wish for a healthy baby. We also wish for long and healthy lives. We don’t always get to choose our health or even learn how to achieve it. I believe one way to help this would be putting more emphasis on health education in school.

It is hard to have good social wealth when your health is poor. You can’t participate in as many social outings or events, and you may have a poorer attitude about your living situation if you have a chronic pain condition. Belonging to a social group, maintaining friendships, being actively engaged in a positive productive way, and even being married all raise your social wealth.

Maintaining financial wealth is more straightforward. You either have money or you don’t. But even when you have money, you are often working on making, getting or winning more. Most of us would love to be millionaires, but even on relatively modest incomes of $75,000, studies show that people are happier.

Now take the average income of someone disabled by pain. Our households typically bring in less than $30,000 and many single disabled people are living on less than $15,000 a year. It is difficult to climb out of a financial rut with poor health and medical bills needing to be paid.

I know chronic pain patients who work, but due to poor health they are not able to take jobs that are high paying or sustainable long-term. Missing work due to illness, brain fog due to pain, depression, anxiety and painsomnia all affect our ability to be productive in a standard work environment. And it is often more difficult for a company hire you due to extra liability or disability costs made to accommodate you.

Even when your own health is good and you are taking care of someone who is disabled, it affects your finances through the type of jobs you take, health insurance, medical bills and supporting the rest of the family.

My husband has lost multiple jobs because my health care and insurance costs were too high for his employers. They found or invented reasons to let him go, such as missing too much work because he had to take time off to drive me to appointments. One company fired him for entering the parking lot without scanning his badge at the guard gate on the way in, a common practice in the mornings when the line to enter the lot was long.

For all of the reasons above, I believe that health wealth is the most important when it comes to living life to the fullest. It takes the most effort and action of all four types of wealth.

We strive to improve our health wealth so that we can live better lives. We don’t have the luxury of waiting for retirement to enjoy ourselves, so we must find and create moments when we can use our time and social wealth. They are the two most easily obtainable when living with chronic illness and striving for health wealth.

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.

‘Mexican Oxy’ Flooding U.S. Black Market

By Pat Anson, PNN Editor

New York City police and DEA agents have announced the seizure of 20,000 counterfeit oxycodone pills made with illicit fentanyl. The pills, which have an estimated street value of $600,000, are blue in color and stamped “M” on one side and “30” on the other, making them virtually indistinguishable from prescription oxycodone.

The fentanyl pills are believed to have originated in Mexico. Known on the street as “Mexican Oxy,” the highly potent counterfeit pills are often cheaper and easier to obtain than pharmaceutical-grade oxycodone. Black market 30 mg oxycodone pills sell on the street for $9 to $30 each and are surfacing around the country.

“If you take prescription pills that did not come directly from a pharmacy, you are risking your life,” said New York City Special Narcotics Prosecutor Bridget Brennan. “Throughout New York City, we have seen a spate of cases involving tens of thousands of potentially lethal fentanyl pills masquerading as oxycodone.

“Just because black market pills have the same color and design as legitimate pills, it does not mean they are safe. The ingredients and potency are all unknown, and minuscule amounts of fentanyl can cause overdose or death. Consuming a counterfeit pill is akin to playing Russian Roulette.”

Overdose deaths in New York City are at record-high levels and fentanyl is involved in over half of them. Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. A customer accustomed to taking oxycodone would not necessarily have the tolerance to ingest illicit fentanyl without suffering an overdose.

DEA PHOTO

Fentanyl powder is typically produced by illicit labs in China and then smuggled into the U.S. through Mexico. The powder is transformed into tablets by pill presses purchased online and then sold by drug traffickers. Four arrests in New York were made in connection with the latest seizure.

“These arrests highlight a growing trend in illicit street drugs which increases the risk of drug overdose,” said DEA Special Agent in Charge Ray Donovan. “Traffickers are mass producing pseudo-pharmaceutical pills made of heroin, fentanyl and other illicit drugs in makeshift laboratories throughout New York City. These pills attract users because they are more convenient and less conspicuous; but users should beware because they are unregulated and lethal.”

Fentanyl Seizures at Mexican Border

Mexican Oxy is also blamed for a rash of overdoses in Arizona, where fentanyl deaths have tripled in recent years.

“It’s the worst I’ve seen in 30 years, this toll that it’s taken on families,” Doug Coleman, DEA Special Agent in Charge of Arizona told the Associated Press. “The crack (cocaine) crisis was not as bad.”  

Last month, the U.S. Border Patrol announced its biggest fentanyl seizure ever — over 250 pounds were found in a truckload of cucumbers at a border crossing in Nogales, Arizona.

Most of the fentanyl was in powder form and over two pounds were made up of pills. Together, they had the potential to kill millions of people.  

“Just because black market pills have the same color and design as legitimate pills, it does not mean they are safe.”

— Bridget Brennan, NYC Narcotics Prosecutor

Most of the fentanyl seized by law enforcement is found hidden inside vehicles at official border crossings around Nogales and San Diego, according to the AP. Smaller shipments of fentanyl are sent directly to the U.S. from China through the mail. The Postal Service’s Inspector General recently reported that over 90 percent of illegal online pharmacies use the mail to ship illicit drugs.

The Postal Service is prohibited from opening packages without a search warrant and is obligated to accept inbound international mail. This makes it more difficult for postal inspectors to identify and track packages suspected of containing illicit drugs. By comparison, private carriers are able to open and inspect packages and can track shipments from beginning to end.

The Inspector General recommended that Congress pass legislation that would give postal inspectors authorization to open and inspect domestic packages suspected of carrying illicit drugs.

Study Finds Vagus Nerve Stimulation Delays Pain Signals

By Pat Anson, PNN Editor

Neuromodulation devices that stimulate a key nerve in the neck – the vagus nerve --- have shown potential in treating a variety of chronic pain conditions, including migraines and autoimmune diseases. A new study helps us understand how the devices work.

Researchers studying post-traumatic stress disorder (PTSD) found that vagus nerve stimulation appears to dampen and delay how the brain responds to pain signals.

"It's thought that people with certain differences in how their bodies -- their autonomic and sympathetic nervous systems -- process pain may be more susceptible to PTSD," said Imanuel Lerman, MD, a pain management specialist and associate professor at the University of California San Diego School of Medicine. “And so we wanted to know if we might be able to re-write this 'misfiring' as a means to manage pain, especially for people with PTSD."

UC SAN DIEGO HEALTH

Lerman and his colleagues at Veterans Affairs San Diego Healthcare System used functional magnetic resonance imaging (fMRI) to get a look at the brains of 30 healthy volunteers after a painful heat stimulus was applied to their legs.

Half were treated with vagus nerve stimulation (VNS) for two minutes -- via electrodes placed on the neck – before the heat stimulus. The other half received a mock stimulation.

Researchers found that VNS delayed the response to heat stimulus in several areas of the brain known to be important for sensory and emotional pain processing. These pain-related brain regions were activated ten seconds later than participants who received sham stimulation. Volunteers who received VNS also sweated less in response to the heat.

“Not everyone is the same -- some people may need more vagus nerve stimulation than others to achieve the same outcomes and the necessary frequencies might change over time -- so we'll need to personalize this approach," said Lerman, who reported his findings in the journal PLOS ONE.  "But we are hopeful and looking forward to the next steps in moving this approach toward the clinic."

The next step for researchers is to conduct a clinical study of VNS on military veterans in the San Diego area. They want to determine if at-home vagus nerve stimulation can reduce emotional pain and neural inflammation associated with PTSD. People with PTSD often have intrusive memories, negative thoughts, anxiety and chronic pain. It is usually treated with psychotherapy, anti-depressants and anti-anxiety medications.

The Food and Drug Administration has approved VNS for the treatment of pain caused by cluster headache and migraine. A handheld device – called gammaCore –  is currently available by prescription for $600 to treat those conditions. 

The Feinstein Institute for Medical Research recently reported that VNS significantly reduced pain and fatigue associated with lupus, an autoimmune disease that damages joints, skin and internal organs. In a small pilot study, lupus patients who were treated with VNS for five minutes daily had a significant decrease in pain and fatigue after just five days.

An implanted vagus nerve stimulator is also being tested for the treatment of rheumatoid arthritis.

FDA Warns Drug Distributor

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has sent a warning letter to a wholesale drug distributor rebuking the company for its handling of several tampering cases involving oxycodone and other medications.

The letter to the CEO of the McKesson Corporation involves incidents in 2016 when pharmacies notified the company about the tampering and theft of medications it had supplied them with.    

In one such case, a Rite Aid pharmacy in Michigan found that the seal to a bottle labeled as containing 100 tablets of oxycodone had been broken. Inside the bottle a pharmacist found 15 tablets of Aleve, a non-steroidal anti-inflammatory pain reliever.  Two other Rite Aid pharmacies also reported to the company that oxycodone bottles had been tampered with. McKesson investigated the reports and determined the tampering and thefts likely occurred while the bottles were in its possession.  

Similar tampering incidents involved drugs used to treat bipolar disorder, high blood pressure and HIV.

According to the FDA, McKesson did little to identify and quarantine other products in its distribution system that also may have been tampered with and failed to warn other pharmacies that illegitimate products were in the supply chain.

"This is simply unacceptable. A distributor’s failure to have systems in place to investigate and quarantine suspect and illegitimate products within their control is a violation of the law," said FDA commissioner Scott Gottlieb, MD, in a statement.

"But this is even more concerning given that we’re in the midst of a widespread opioid crisis. Opioids that leave the legitimate supply chain could end up being sold illegally, or a patient who was appropriately prescribed these drugs to treat pain may not get the treatment they need or may unknowingly take a medication that’s not meant for them."

The FDA did not say why it waited so long to send the warning letter or notify the public about the 2016 tampering incidents. McKesson is the first company to receive a warning letter under the Drug Supply Chain Security Act (DSCSA), which was enacted by Congress in 2013.

McKesson is one of the largest wholesale drug distributors in the country. It is being sued by dozens of states, cities and counties for its role in the opioid crisis. In 2017, McKesson was fined $150 million for failing to report suspicious orders for oxycodone, hydrocodone and other controlled substances. In 2008, the company agreed to pay $13.25 million in penalties for similar violations.

Guideline Paranoia

By Carol Levy, PNN Columnist

I recently posted an article to an online chronic pain support group about the CDC’s opioid prescribing guideline.

“For treating acute pain, the guideline recommends a quantity no greater than what is needed for the expected duration of pain severe enough to require opioids, specifying that three days or less will often be sufficient and more than seven days will rarely be needed,” the guideline states.

It makes sense to me. And I assumed that would be the response my post would get. The recommendation is only for treating acute pain and acute pain shouldn’t need chronic, long term opioid treatment.

Instead, the replies were quick, angry and knee jerk:

“How dare they decide what and how many we need? This will hurt chronic pain patients.”

“They always come after us. These may be for acute pain patients, but you just know more draconian guidelines are just around the corner for chronic pain patients.”

The CDC guideline does not say, “And no one, even if their acute pain continues longer than 3 or 7 days, will be able to get the pain meds they need.” But that was how it was interpreted.

And then the people replying went one step further: “Soon they will be writing guidelines that even those in chronic pain can only have opioids for a specified period of time and a specific dosage, and not one grain more or one day longer.”

I see this common response and reaction as a major issue. When any new guideline is proposed (and people forget these are guidelines, not absolutes), it is a major catastrophe: “They are coming after us.”

Too often we act in a way that appears akin to addictive behavior. We have to have our opioid medications. And any restriction, even when it is not related to chronic pain, is one restriction too many: “They are going to take away my drugs. Then what will I do?”

We seem to have lost the concept of consideration. No time is taken to think through the new suggestions. Instead it is an immediate jump to: “This will hurt me. I won't be able to get the meds I need.”

For many of us, opioid medication is all that is left or the only option. The idea that someone, especially the government, may rip them from us is truly terrifying.

But I wonder. Maybe if we did not take any and all new guidelines as a frontal attack on us, maybe we would not be seen and referenced so often as a major component and cause of the “opioid epidemic.”

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 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.

Ambroxol: A Potential New Treatment for Chronic Pain

By A Rahman Ford, PNN Columnist

Researchers say a drug long used in cough syrup and cold medicines shows potential for treating some types of neuropathic pain.

A small study recently published in the journal Headache found that topical administration of ambroxol in a cream could significantly decrease pain in patients with trigeminal neuralgia, a chronic facial condition that can make even routine tasks such as brushing one’s teeth excruciatingly painful. 

In their review of the medical records of five trigeminal neuralgia patients, German researchers reported that all five patients experienced pain reduction with ambroxol 20% cream being applied within 30 minutes of a pain flare, with pain relief lasting from 4 to 6 hours.  In one case, pain was eliminated completely in one week.  

The results were similar to those of previous German studies and were so significant that researchers recommended that ambroxol “should be investigated further as a matter of urgency.”

Similarly, a recent study in the journal Pain Management found that application of topical ambroxol reduced spontaneous pain in several patients with complex regional pain syndrome (CRPS), a little understood nerve condition that causes chronic pain after a significant injury or surgery.  Notably, ambroxol therapy improved several other neuropathy-related conditions in CRPS patients, including edema, allodynia, hyperalgesia, skin reddening, motor dysfunction and skin temperature.

An Old Drug with a New Purpose

With a pharmacological history that can be traced back to Indian ayurvedic medicine, ambroxol was initially approved in 1978 as a medication to break down mucus and make it easier to eliminate by coughing.  It is generally administered in tablet or syrup form. 

Ambroxol is also used to treat a sore throat associated with pharyngitis, thus its potential role as a potent local anesthetic.  The drug’s anesthetic properties stem from its ability to block sodium and calcium channels that transmit pain signals.

Although the idea that ambroxol can treat a sore throat is widely accepted, its application to other forms of pain is more recent.  

Previous studies using animal models of neuropathic pain have been promising.  In a 2005 study, researchers effectively reduced – and in some cases eliminated – chronic neuropathic and inflammatory pain in rats. Indian researchers also found ambroxol effective in treating neuropathic pain in rats, attributing its success to its antioxidative and anti-inflammatory properties.  Unfortunately, human studies are few at this point.

Ambroxol and Fibromyalgia

A 2017 Clinical Rheumatology study showed that ambroxol can play a key role in treating chronic pain associated with fibromyalgia.  As reported by Fibromyalgia News Today, researchers from Mexico added ambroxol to the treatment regimens of 25 fibromyalgia patients, three times a day for one month.  At the end of the study, pain scores decreased significantly and there was also noticeable improvement in sleep disturbances, stiffness and autonomic nervous system dysfunction.  No major adverse events were reported. 

Another 2017 study supported these findings, with the authors concluding that “fibromyalgia treatment with ambroxol should be systematically investigated” because the drug “is the only treatment option used thus far that has the potential to address not just individual but all of the aforementioned aspects of pain.”

Although data on its effectiveness in humans are limited, ambroxol shows great potential in treating painful conditions for which there are currently few safe and effective options.  It is particularly attractive because it has few significant side effects, is not addictive and can be administered topically in some instances.

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.

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.

‘Cannabis Tourism’ Linked to More Fatal Accidents

By Pat Anson, PNN Editor

Has marijuana legalization made driving more dangerous?  There have been conflicting claims over the years that states where cannabis is legal have more car crashes. And one recent study found that over half of medical cannabis users drive while impaired.

A new study adds a little more clarity to the issue.

Researchers at Monash University in Australia looked at traffic fatalities in three U.S. states where recreational cannabis was legalized (Colorado, Washington and Oregon), and in eight neighboring states and British Columbia.

They found there was an average of one additional traffic fatality for every million residents. That may not sound like much, but when you consider there were 27 million people in the affected areas, it adds up to 170 additional deaths in the first six months after legalization.

Many of the additional deaths were attributed to “cannabis tourism” in which people in neighboring states and provinces purchased recreational cannabis in legalized states and then drove home while under the influence.

"The results suggest that legalizing the sale of cannabis for recreational use can lead to a temporary increase in traffic fatalities in legalizing states. This spills over into neighboring jurisdictions through cross-border sales, trafficking, or cannabis tourists driving back to their state of residence while impaired,” says lead author Tyler Lane, PhD, a postdoctoral research Fellow at Monash.

"Our findings suggest that policymakers should consult with neighboring jurisdictions when liberalizing cannabis policy to mitigate any deleterious effects."

Because the increase in fatalities was temporary, Lane believes it could be due to an initial “celebratory response to legalization” that contributes to cannabis tourism. His study was published in the journal Addiction.

Fatalities Drop in Medical Cannabis States

While fatalities rose in states with recreational cannabis, Lane notes that previous research has found a decrease in traffic fatalities in states that legalized medical marijuana. That may be because patients may be substituting cannabis for alcohol and other controlled substances used to relieve symptoms.

“There seem to be differences between medicinal and recreational user consumption patterns. Medicinal users have a tendency to substitute, but recreational users are more likely to treat alcohol and cannabis as complements and use them together,” Lane said in an email to PNN. 

“Because marijuana on its own is less impairing than alcohol, and combined used is much more impairing than either in isolation, it suggests that when people substitute alcohol for cannabis (in the medicinal use context), they will still be impaired, but to a much lower degree than if they were still using alcohol.” 

This “harm reduction role” of medical cannabis was noted in a 2016 Canadian study that found patients reduced their use of alcohol, illicit drugs and prescription drugs when cannabis was taken for medical reasons. 

Medical marijuana is currently legal in 33 states and Washington DC, and ten states allow its recreational use.

Are Most Retired NFL Players Really Addicts?

By Lynn Webster, MD, PNN Columnist

Many of us watched the Super Bowl on Sunday. It was a great defensive game, which means there was a lot of hard-hitting contact. Physical trauma can bring about long-term consequences and that is the subject of a recent New York Times column, "For NFL Retirees, Opioids Bring More Pain" by Ken Belson.

Belson suggests that many retired NFL players become addicted to opioid medication. I don’t know how many former players become addicted, but the summation of players he describes as addicted doesn’t quite add up.

The column cites a recent study published in the Clinical Journal of Sport Medicine that found about 26 percent of retired football players used opioid medication during the past 30 days. Belson suggests that percentage is excessive.

Of course, the players were not addicted just because they used an opioid. Moreover, 26 percent does not seem to be an unreasonable number, given that this is a population with a history of tremendous physical trauma. In fact, it seems like a surprisingly low number given that most former football players experienced enormous physical trauma for years.

Whatever the actual data may be, we can probably attribute the use or misuse of opioids to the fact that these retired players were trying to mitigate severe pain.  

What is Misuse?

The accepted definition of opioid "misuse" is taking an opioid contrary to how it was prescribed, even if it is taken to treat pain. For example, let's say a person is told they can use one hydrocodone three times a day. If that person uses one pill six times a day so they can function (and not to get high), that is considered misusing. However, that is not a sign of addiction. It only reflects the person's desire to escape pain and the therapeutic inadequacy of the prescribed medication. 

Misuse of opioids in the general population is relatively rare, according to a large new study published in the journal Pharmacoepidemiology & Drug Safety. Over 31,000 adults were surveyed about their opioid use, and only 4.4% admitted taking a larger dose or a dose more frequently than prescribed.  

The figure below helps explain the relationships of misuse, abuse and addiction. Some retired football players may misuse their medication, but few will abuse them and even fewer will become addicted. All people with addiction abuse their medication. But people who misuse their medication may not be abusing or addicted to it.  

In his column, Belson cites a 2011 survey by researchers at the Washington University School of Medicine that found over half of former NFL players used opioids during their playing careers and 71 percent misused them.

The same study found that many of these retired players who misused opioids were heavy drinkers. But in his column, Belson reported that "players who abused opioids” were likely to be heavy drinkers.  

Belson uses the words “misuse” and “abuse” interchangeably, as if they have the same meaning. They do not. If Belson means that retired players took opioids in excess of what their doctors prescribed due to uncontrolled pain, that would not be abuse. It would be misuse. If the players were using opioids to get high, that would be abuse. 

Belson mentions one retired player using the same amount of pain medicine as a stage 4 cancer patient and suggests that is an excessive amount. However, the player's need for that amount of opioids should not surprise us. Cancer pain is not more painful than non-cancer pain. People with painful diseases and physical injuries may have pain just as debilitating as a patient dying from cancer.

It is unfortunate, but not shocking, that a retired football player would have as much pain as someone dying of cancer. When someone who does not have cancer uses excessive medication to relieve pain, we are more likely to label that as "abuse." We show more compassion to patients with cancer pain than we do toward anyone else who requires treatment for chronic pain.  

Why We Need Clarity About Our Terms 

Belson writes, "Now, a growing number (of players) are saying the easy access to pills turned them into addicts." That is another statement that gravely concerns me. It is misleading and consistent with the common misunderstanding of what causes addiction or even what addiction is.  

Becoming dependent on opioids, becoming tolerant to opioids, requiring more opioids over time to achieve the same level of pain relief, and experiencing withdrawal if the opioids are suddenly stopped are not necessarily signs of addiction, any more than they would be if the same consequences resulted from taking a blood pressure medication or a sleep aid.  

People frequently write and talk about misuse, abuse and addiction, but many of them don't know what the terms mean.  This has troubling implications for the pain and addiction communities. Mislabeling and misdiagnosing people with addiction leads to harmful policies that adversely affect treatment. It even has legal implications that prevent people in pain or with addiction from accessing appropriate clinical care.  

Severe chronic pain and addiction can devastate lives. But we need to know the differences between misuse of, abuse of, and addiction to medications for the appropriate policies to be implemented. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

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.

Heart Transplants Surge as Overdoses Increase

By Pat Anson, PNN Editor

One of the more ghoulish and yet beneficial aspects of the overdose crisis is that it has led to a surge in organ transplants. In 2000, only about 1 percent of organ donors were overdose victims. By 2017, when over 70,000 Americans died from drug overdoses, over 13 percent of organ donors were overdose victims.

A new study by researchers at Brigham and Women’s Hospital has documented how the number of hearts available for transplant has increased dramatically, particularly in states like Pennsylvania that have been hard hit by the overdose crisis.  

"In the U.S., the drug crisis is clearly not uniform, and neither is the rate of recovered hearts from drug-intoxication-related deaths," said lead author Mandeep Mehra, MD, the medical director of Brigham's Heart and Vascular Center.

Mehra and his colleagues analyzed CDC data on overdose deaths and from the Organ Procurement and Transplantation Network, and reported their findings in The New England Journal of Medicine.

They found major increases in drug-related deaths and organ harvesting in Pennsylvania, New York, Ohio and other Northeast states, and in Florida and Texas. Overall, the team estimated that 6.24 hearts were recovered for every 1,000 lives lost due to drug intoxication.

NEW ENGLAND JOURNAL OF MEDICINE

Among the 37,232 donors whose hearts were transplanted from 1999 through 2017, the percentage of those who died from overdoses rose from 1.5% to 17.6 percent. And as the number of hearts available for transplant grew, the waiting list for donated hearts began shrinking in 2016. According to the United Network for Organ Sharing, there are currently 45 people in the U.S. waiting for a heart transplant.

"This is a very important outcome indicating that people are now adopting organs from drug-intoxication-related deaths as a viable source for lifesaving donor organs," said Mehra. "Although we support organ donation recovery from this source, those of us in the transplant community also strongly support effective efforts to combat the drug overdose crisis. We must pursue ways to target the crisis while simultaneously looking for new ways to increase the availability of viable donor organs."

There has long been a stigma against using donated organs from overdose victims because the organs may be damaged due to reduced oxygen supply and because drug addicts are more likely to be infected with HIV, hepatitis and other communicable diseases. But those risks have been minimized with modern testing.

The United Network for Organ Sharing requires organ recipients to be made aware of the circumstances of higher risk donations, so they can decide whether or not to accept it. There are over 113,000 Americans currently waiting for an organ donation, including many who have been on the waiting list for years.