Stem Cell Therapy for Lower Back Pain Moves Closer

By A. Rahman Ford, PNN Columnist

There’s good news on the horizon for those who suffer from lower back pain due to disc degeneration.

Mesoblast, an Australian biotech company, has partnered with Grunenthal, a large German pharmaceutical company, to commercialize an investigational stem cell product called MPC-06-ID -- a stem cell formula comprised of mesenchymal cells derived from the bone marrow of healthy volunteers. Mesoblast could receive up to $1 billion from Grunenthal if the treatment is successful.

MPC-06-ID is currently in a Phase III placebo-controlled trial in the U.S. In the trial, millions of stem cells grown in a laboratory are injected into the patients’ degenerated discs with the goal of reducing inflammation and causing the discs to regenerate.

In previous trials, 47% of those who received the injection had a significant reduction in pain 12 months later. The results persisted for three years.

The estimated study completion date for the Phase III trial is March 2021. So, unfortunately, there is a bit of a wait. But Mesoblast is hopeful the study findings will result in FDA approval.

The company is also studying a stem cell product for chronic lower back pain. More on Mesoblast’s products and how they treat back pain can be found here.

What does this mean? First and foremost, it’s great news for people suffering from back pain. This is a population that is woefully underserved by conventional medicine. Limited options include analgesics like opioids, which are increasingly difficult to obtain, and spinal surgery that is costly, often ineffective and can even exacerbate the problem. I have previously written about these issues here.

Clinicians around the country have been using stem cell therapy (SCT) for years to treat back pain and even difficult spinal conditions like arachnoiditis. However, these clinics have been operating under the scythe of potential persecution for using products not approved by the FDA.

Not only has this placed them squarely in the crosshairs of regulatory authorities which issue warning letters and file lawsuits, but it has also subjected them to internet censorship by Google and others.

The Mesoblast-Grunenthal partnership is indicative of the fact that major corporate investment in SCT is increasing -- and that can be a great thing for consumer choice. More and more biotech investors are recognizing that SCT is the future of medicine, especially when it comes to treating conditions caused by chronic inflammation. Forbes reports that the market size of the SCT industry was $8.65 billion in 2018, with a projected annual growth rate of 8.8%.

We saw recent evidence of this trend with Bayer’s acquisition of Bluerock Therapeutics’ and its stem cell treatments for Parkinson’s disease and other chronic illnesses. And Boston-based Vertex Pharmaceuticals recently acquired Semma Therapeutics for $950 million in a bet that its SCT products could cure type 1 diabetes.

Why is the SCT market so robust? Transparency Market Research attributes it to a “rise in consumer awareness.” In other words, people are desperate for relief and looking for new treatments. Suffice it to say, any additional treatment option for those suffering from back pain is more than welcome.

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.

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 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.

Fibromyalgia Researchers, It’s Time to Stop Watching the Flowers Grow!

By Donna Gregory Burch

As a fibromyalgia warrior and blogger, I read a lot of articles about new research findings. I continue to be amazed by how much time and money are wasted by researching the obvious or studying the same treatments over and over again.

After all, how many times do we need to prove meditation can reduce fibromyalgia pain? Didn’t we figure that out years ago?

I really thought I’d seen it all until an article entitled, “The Power of Flowers May Ease Fibromyalgia Symptoms,” showed up in my inbox last month.

As I read it, I literally said out loud: “Are you kidding me?”

In case you haven’t read the article, it summarizes a recent Israeli study in which 61 women with fibromyalgia completed a 12-week flower design course presented by a trained florist. At the end of the course, Tel-Aviv University researchers reported “quite amazing” improvements in the women’s fibromyalgia symptoms.

Yep, you read that right: The researchers claim arranging a few daisies and baby’s breath in a vase actually improves fibromyalgia.

Now, I don’t doubt for a minute that flower arranging is relaxing and could have a calming effect on the central nervous system. That, in turn, could lead to a reduction in pain and other fibro symptoms.

But so could watching butterflies or painting rocks.

While I think it’s wonderful researchers are looking at non-pharmaceutical treatments for fibromyalgia, studies like this completely invalidate the seriousness of our condition. These types of studies make it seem like almost anything will fix fibro, and that is just not reality.

Because of the stigma of fibromyalgia, we already struggle to prove to our doctors and loved ones that we’re really sick. What do you think the average person is going to think when they read flower arranging helps fibromyalgia? While I’m sure the researchers had good intentions, this study makes a complete mockery and joke out of an extremely painful, life-sucking condition.

In my mind, I think back to all of those doctors who tried to give me anti-depressants and anti-anxiety medications when I complained about unexplained pain, fatigue, bladder urgency, neuropathy and a long list of other symptoms. The message was clear: “It’s all in your head. You’re just a stressed out, middle-aged woman who needs to chill out.”

What happens when these same doctors read the Israeli study? I can envision them now referring their patients to the nearest community college for classes on cupcake baking and basket-weaving. As if we weren’t frustrated enough with the conventional medical system!

The truth is we don’t need more BS fibromyalgia studies like this one. We need researchers to get serious! We need them to take a deep dive into the minds and bodies of fibromyalgia patients and figure out what causes us to feel like a three-day-old warmed over microwave dinner.

We need real solutions – treatments that get to the root cause of our illness – not a new hobby!

Donna Gregory Burch lives with fibromyalgia and chronic Lyme disease. Donna covers news, treatments, research and practical tips for living with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter.

Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

Kolodny Clarifies His Conflicts of Interest

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has revised his conflict of interest statements for two articles he co-authored in the Journal of the American Medical Association (JAMA) to include his work in malpractice lawsuits involving opioid medication.

Kolodny, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), is a longtime critic of opioid prescribing. He recently testified as the “star witness” for Oklahoma in its opioid negligence lawsuit against Johnson & Johnson, a case the state won with a $572 million judgement against J&J.

“I am writing to provide additional information to clarify conflict of interest disclosures in 2 articles I published in JAMA in 2017 and 2018.  During this time, I received compensation for work as an expert in malpractice litigation involving opioid prescribing,” Kolodny wrote in a Sept. 4 letter to JAMA’s editors.

“When the articles were first published, I did not believe this work could be perceived as a potential conflict of interest. My view has since changed. In the spirit of full transparency, I am requesting a correction to my disclosure statements.”

The two JAMA articles in question, which were co-authored by former CDC director Thomas Frieden, MD, both dealt with the opioid crisis and the federal policy response to it.

JAMA disclosure policy is very clear and requires authors to list “all relevant financial interests, activities, relationships and affiliations,” including payments for employment, consultancies and expert testimony.

During the Oklahoma trial, Kolodny admitted under questioning by J&J lawyers that he was being paid $725 an hour by Nix Patterson & Roach, one of three law firms hired by Oklahoma to handle the case against J&J. Kolodny anticipated being paid up to $500,000 by the end the Oklahoma trial.

“I don’t think it should be a secret that I’m being compensated,” he said.  

Kolodny also acknowledged working for the law firm of Cohen Milstein Sellers & Toll in a similar capacity, also for $725 an hour. Cohen Milstein is heavily involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois. 

Kolodny’s work in opioid litigation was disclosed in the April 2018 JAMA article.

DR. ANDREW KOLODNY

His revised disclosure statement for that article is vague, stating that he worked as “a medical expert for states and counties that have filed suits against opioid manufacturers and as an expert witness in malpractice cases involving opioid prescribing.” It does not identify which states, counties and law firms he worked for or what companies were being sued. 

JAMA policy calls for “complete disclosure of all potential conflicts of interest” covering a three-year period prior to an article being submitted. If an author received funding from the pharmaceutical industry, for example, he or she would be expected to identify the company involved.   

“It is encouraging that Dr. Kolodny has recognized that his very profitable work supporting plaintiffs in opioid lawsuits might constitute a conflict of interest when he writes about opioid policy and clinical practice,” said Bob Twillman, PhD, a healthcare policy consultant and former Executive Director of the Academy of Pain Management. “Of course, these aren't the only two articles Dr. Kolodny has co-authored, and he has done numerous presentations at professional meetings as well, so I wonder if he will seek to correct all the rest of those relevant disclosure statements.

“I think it's also interesting that, when I disclose my conflict, I am always required to specifically name the entity involved, yet Dr. Kolodny names neither the jurisdictions nor the law firms for which he was working. It seems a little like a double standard to me, and I wonder how the editorial boards of the relevant journals feel about that.”

In March 2017, Kolodny co-authored a research letter in JAMA Internal Medicine on a study he designed that looked into funding that patient advocacy groups and professional organizations received from opioid manufacturers. Many of those organizations publicly opposed the CDC’s controversial opioid prescribing guideline, which Kolodny and other PROP members helped draft.

“The CDC did not prompt or require organizations to disclose their financial associations as part of their comments. Disclosure, however, is one means of managing conflicts of interest,” Kolodny and his co-authors wrote. “Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.”

Kolodny’s disclosure statement for the 2017 article states that he was a member of PROP and Chief Medical Officer for the addiction treatment chain Phoenix House (which he has since left). It makes no mention of his work in opioid litigation or malpractice lawsuits, which may have begun at a later date.

Lucrative Sideline

Kolodny is not the only critic of opioid prescribing to develop a lucrative sideline as a medical expert or paid witness. Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University that seeks to expose deceptive healthcare marketing practices, has also been paid handsomely for her testimony.

In August, Fugh-Berman testified in California that she was paid $500 an hour for her work in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case, according to Northern California Record.

Fugh-Berman has written several op/eds claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were part of a “coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline.”

Fugh-Berman discloses on PharmedOUT’s website that she is a paid expert witness, but she won’t say who funds her organization.

“(We) are funded primarily by individual donations, mostly small donations but we have several major donors. We do not provide the names of our individual donors,” she said in an email to PNN.  

Dr. Timothy Munzing, a Kaiser Permanente family practice physician in California, has also stoutly defended the CDC guideline and warned against excessive opioid prescribing.

“Most prescribing physicians feeding the opioid epidemic are well meaning, naïve, or just too busy to recognize the dangers,” he wrote in a physician guide for opioid prescribing published by Kaiser Permanente.

Over the past decade, Munzing has established a profitable career as an expert witness for the Medical Board of California, DEA, FBI and DOJ, working mostly on cases that involve doctors flagged for overprescribing opioids.

According to GovTribe.com, which tracks payments to federal contractors, Munzing has been awarded nearly $1.3 million in DOJ contracts since 2017 and is currently working on over two dozen DEA investigations.

After he left Phoenix House, Kolodny became the co-director of an opioid research program at Brandeis University that is funded with over $8.5 million federal grants, according to GovTribe.com.

There’s More Concern About Animals Suffering Than People

By Debbie Westerman, Guest Columnist

I have Complex Regional Pain Syndrome, as well four herniated discs in my lower back. Because of the “opioid crisis,” I was taken off the only medication that ever helped: fentanyl.

I see a reputable doctor and he is very sympathetic. But as he put it, doctors are no longer just being sued, they are being threatened with jail time.

In addition to my pain and fear, I felt so sorry for him. We’ve tried everything: nerve blocks, injections and I have two spinal cord stimulators.

I was weaned off the fentanyl and only have hydrocodone that I take for breakthrough pain. 

I’ve done everything I’m supposed to. I have an appointment with my doctor every 28 days, along with random drug tests to make sure I’m only taking what he’s prescribing.

My insurance doesn’t pay for the random drug tests. I have to pay $150 each time. I don’t abuse my meds. All of my doctors know what I’m taking. I don’t get any type of pain meds from anyone except my pain management doctor.

DEBBIE WESTERMAN

I have to go to work every day. I’m single and have to take care of myself. I use a walker to get around. It’s been months since I have slept more than 2 to 4 hours a night. I’m constantly turning over, putting the pillow under my legs or between my legs, and the rest of the night I’m in and out of bed trying to walk because the pain is so bad.

What really gets me is that if I were an animal and suffering this bad with this much pain, I would be humanely put down. As a society we’ve become more concerned about our animals than we are about people who are suffering unspeakable, unexplainable amounts of pain.

I’ve never wished my pain on anyone. But I really wish that there was some way that these people who think they know what’s best for me could spend 6 hours in my shoes. I guarantee they would be screaming a different tune.

Debbie Westerman 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 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.

The Visible Few Pain Patients

By Dr. Lynn Webster, PNN Columnist

I receive several emails a week from people who ask for help because their treatment options have been limited or eliminated. They are in terrible pain, and they don’t know what to do.

One such person, Sharon Berenfeld, MD, recently shared an experience she had visiting her doctor.

“Dr. Webster, I came across a publication of yours. It struck a nerve with me. My pain is intractable. I have tried everything,” she wrote. “Before the exam room door even closed, [my doctor] announced to me, ‘If you think I’m just here to refill your pills, you can leave now.'

"I left in tears. I was being judged and punished for having a complication from cancer treatment. I completely understand the opioid crisis. But I feel impotent to do anything."

Who Are the Visible Few?

Earlier this year, Fox News' three-part series, Treating America's Pain: Unintended Victims of the Opioid Crackdown, showed the terrifying circumstances of people in pain and doctors under siege. One individual’s decision to commit suicide as a result of the crackdown on opioid prescribing embodies the struggles of people in pain and their providers' inability to meet their needs.

The visible few are the small number of people whose stories have been heard by journalists, media consumers and government officials. Their stories reflect millions of Americans suffering from chronic pain who live in the shadows and are invisible to most of us. 

The needs of people in pain and the challenges providers face when treating them have been overshadowed by the government's attempts to deal with the opioid crisis. The well-intentioned CDC Guideline for Prescribing Opioids for Chronic Pain has affected 20 million Americans with severe disabling pain.

It also is having consequences for everyone else in the healthcare system. Prescription opioids have been demonized and blamed for our current drug crisis.

Unintended Consequences

The CDC guideline was supposed to be voluntary. However, in practice, the guideline has been treated as a policy with the strength of a law, and it has had severe unintended consequences. Many people are worse off in its wake. Here is a summary of the most substantial effects of the guideline.

• Providers feel pressured to reduce the amount of opioids that they prescribe, regardless of their patients' individual needs. About 70% of physicians have reduced their opioid prescribing or stopped it completely.

• Insurance companies set prescription limits based on the guideline. In some cases, they override physicians' recommendations. That means insurers, rather than doctors, are making decisions about how to treat pain.

• Pharmacy chains are also limiting the amount of opioids they dispense, based on the guideline rather than on doctors' prescriptions..

• The Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services have set dosage limits. Providers advocating for patients who need higher amounts must navigate a complicated appeals process.

• State attorneys general have used the guideline to evaluate whether a doctor is prescribing for a legitimate medical purpose. Deviation from the guideline has been used to accuse doctors of criminal conduct.

• In a desperate search for pain relief, some patients have turned to street drugs.

Where We Are Now

The CDC guideline has left a trail of misunderstanding in its path. Its authors acknowledged misapplication of the guideline in the New England Journal of Medicine, emphasizing that their intention was to provide guidance rather than to establish a mandate.

"Difficulties faced by clinicians in prescribing opioids safely and effectively, growing awareness of opioid-associated risks, and a public health imperative to address opioid overdose underscored the need for the guidance,” they wrote.

In a separate article in the JAMA Network, the guideline's authors said, “The number of people experiencing chronic pain is substantial, with U.S. prevalence estimated at 11.2% of the adult population. Patients should receive appropriate pain treatment based on careful considerations of the benefits and risks of treatment options.”

There are other signs of recognition that the guideline has been misinterpreted. For example, CDC Director Robert Redfield, MD, wrote in a letter to Health Professionals for Patients in Pain (HP3), “The CDC is working diligently to evaluate the impact of the guideline and clarify its recommendations to reduce unintended harm.”

The American Medical Association's House of Delegates passed a series of resolutions on the guideline at an interim meeting in November 2018.

“Physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the morphine milligram level thresholds found in the CDC guidelines for prescribing opioids,” the AMA delegates said.

There is also some light being shined on the issue in a report by The Pain Management Best Practices Inter-Agency Task Force.

“There is no one-size-fits-all approach when treating and managing patients with painful conditions. Individuals who live with pain are suffering and need compassionate, individualized and effective approaches to improving pain and clinical outcomes. This is a roadmap that is desperately needed to treat our nation’s pain crisis,” said Vanila Singh, MD, task force chair and chief medical officer of the HHS Office of the Assistant Secretary for Health.

As the opioid odyssey continues, there are signs that the visible few are beginning to be heard. This is an important step to helping the invisible millions with chronic pain receive the care they deserve.

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

The information in this column 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.

Winning My Disability Case

By Mia Maysack, PNN Columnist

Never had I ever sent a thank you note to a judicial official. Not until I learned, after a four-year long process, that my disability case has been approved.  

So I write this teary-eyed, realizing I can now look into getting an oxygen tank for my cluster headaches, as the ability to obtain one through regular insurance was denied multiple times. I can also implement regular massages into my pain management plan, which might sound luxurious but for me is more a matter of physical functionality.

This decision will give me bits and pieces of my life back. The money will be extraordinarily helpful, a lifesaver really.   

I have chosen to no longer feel anything negative about deciding to pursue my case. Perhaps I don't deserve it as much as the next person or maybe I am too young or able bodied at times to even have filed. 

I pursued my claim only as a last resort, holding onto my identity as a worker and employee for dear life — and for far longer than what was in my best interest.

There's no question that part of what heightened my ailments is the fact that I pushed myself too far for a very long time. But having already been so used to daily head pain, I kept my head up by remaining busy and distracted on other things. That’s how I survived.

I also attempted countless career paths to accommodate my illnesses, including but not limited to working part-time, shortening shifts, changing job titles and even accepting positions I was overqualified for because being a part of the workforce has always been a value of mine.  

I've been fired, had hours cut to the point of being forced to quit, experienced pain induced panic attacks and frequently needed to leave work -- unfortunately not with fair warning or adequate notice to my employer. This resulted in judgement and discrimination, despite never being offered accommodations. Nor were there efforts to follow the detailed instructions of my care team by anyone other than me.

So it made the most sense to represent myself at my disability hearing,  as I am my own best expert.  

Applying for disability is extremely strenuous, tiresome and at times very frustrating. Between jumping through the insurance hoops as they try their best to justify not covering what is needed, maintaining numerous appointments, and balancing all the paperwork on top of being chronically ill and in pain. It is no exaggeration to say the disability process is a full-time job.   

Then there's the potential for added hurt when met with the assumption you could just be lazy, exaggerating or are perhaps flat out lying, because it's undeniable that the system has indeed been used and abused. 

To finally have been granted an opportunity for a face-to-face in-person hearing was a gift. It provided the opportunity for me to make my case real. I felt empowered to fully exercise my rights.

I’m also thankful to have crossed paths with someone who I considered to be a fair judge. They corresponded with a vocational expert, treated me with respect (even after I turned down the final chance to have a lawyer represent me), and took all evidence into thoughtful consideration, including the neurology report and testimony of a witness who accompanied me.  

I share this to serve as an illustration of what it's like to travel down this road. It took a lot of detours and led to quite a few dead ends, but to put a face on the “invisibility” that millions of us live with and have it validated is another small step forward.   

Upon being dismissed, the clerk congratulated me and said something that will stick with me forever: "It's not that you weren't doing or wouldn't continue to do well in past endeavors but your calling is higher."

We can find meaning to our lives despite all the rerouting. Sometimes we're even able to build an entirely new path.

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 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.

Outcomes Matter When Opioids Are Tapered

By Roger Chriss, PNN Columnist

The drug overdose crisis has led to a rethinking of pain management. Prescription opioids are now seen as risky medications with potentially serious side effects, including addiction and overdose. As a result, there is an increasing push to discontinue or taper patients on long-term opioid therapy.

A recent op/ed in the Annals of Internal Medicine by physicians Roger Chou, Jane Ballantyne and Anna Lembke claims there is “little benefit” from long-term opioid use and “many patients” would benefit from tapering. They even suggest that the use of addiction treatment drugs such as Suboxone should be expanded to include pain patients dependent on opioids.

“Evidence indicates that long-term opioid therapy confers little benefit versus nonopioid therapy, particularly for function. Opioid use disorder (OUD) occurs in a subset of patients, and quality of life may be adversely affected despite perceived pain benefits,” they wrote.

“We argue that achieving effective, safe, and compassionate tapers requires implementing and incentivizing tapering protocols, recognizing prescription opioid dependence as a distinct clinical condition necessitating treatment, and expanding the indication for buprenorphine formulations approved for OUD to include prescription opioid dependence.”

It should be noted Chou is one of the co-authors of the CDC’s controversial opioid prescribing guideline, while Ballantyne and Lembke are board members of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). Ballantyne, who is president of PROP, was part of the “core expert group” that advised the CDC when it was drafting its guideline.

What Happens to Tapered Patients?

The goal of improving patient safety is admirable. However, there is relatively little data on what happens to patients during tapering or after opioids are discontinued. The evidence is mixed at best.

A 2018 review in Pain Medicine of 20 studies involving over 2,100 chronic pain patients found that most patients had less pain or the same amount of pain when tapering was completed. But the studies were not controlled and the evidence was of marginal quality, with large amounts of data missing.

A 2019 study in the journal Pain evaluated outcomes in 49 former opioid users with chronic pain. The findings showed that about half the patients reported their pain to be better or the same after stopping opioids, while the other half reported their pain was worse.

There are risks associated with tapering that also need to be considered, such as uncontrolled pain, suicide, overdose and early death. The tapering process itself can be extremely challenging and patient outcomes after discontinuation are not necessarily positive.

A recent study in the Journal of General Internal Medicine looked at what happened to chronic pain patients being treated at a large urban healthcare system in the year after they were tapered.

For about 5 percent of patients, “termination of care” was the primary outcome – a vague category that means there was no record of them seeking further treatment. Some of those patients may have miraculously gotten better and required no healthcare. And some may have died.

“These findings invite caution and demonstrate the need to fully understand the risks and benefits of opioid tapers,” the authors warned.

Another study in the same journal is also concerning. Researchers at the University of Washington followed 572 patients who were treated with opioids at a Seattle pain clinic. About 20 percent of the patients died, a high mortality rate, but the death rate was even higher for patients who were tapered. Seventeen of them died from a definite or possible overdose.

“In this cohort of patients prescribed COT (chronic opioid therapy) for chronic pain, mortality was high. Discontinuation of COT did not reduce risk of death and was associated with increased risk of overdose death,” the authors concluded.

"We are worried by these results, because they suggest that the policy recommendations intended to make opioid prescribing safer are not working as intended," said lead author Jocelyn James, assistant professor of general internal medicine at the University of Washington School of Medicine. "We have to make sure we develop systems to protect patients."

In other words, opioid discontinuation does not necessarily lead to better outcomes, as Chou, Ballantyne and Lembke suggest. The blind push to taper patients at all costs to reduce opioid prescribing can have tragic consequences — which no one seems to be tracking.

“Crucially, today’s opioid prescribing metrics take no count of whether the patient lives or dies. Data from two recent studies strongly suggest it is time to start counting. The sooner quality standards are revised in favor of genuine patient protection, the better,” says Stefan Kertesz, MD, an Alabama physician and researcher.

Outcomes matter. And they need to be reasonable for the patient. A person with a self-limiting condition like low back pain may well benefit from opioid discontinuation. But some patients with more chronic conditions do not get better, and their needs cannot go ignored.

The Canadian Psychological Association emphasizes caution and patient safety in a recent position paper on the opioid crisis:  “Tapering must always be done gradually under physician or nurse practitioner supervision, with the patient's consent, and with ongoing support and monitoring of pain and functioning, as well as management of withdrawal symptoms."

The use of prescription opioids should always take patient risks and benefits into consideration. It also requires knowing about outcomes when taking patients off opioids. At present there is too much interest in numbers and too little interest in people.

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.

Enough Is Enough!

By David Eaton, Guest Columnist

Back in 2007, when my back pain became so severe that it was affecting my ability to work, I wrote an email to my boss using the subject line, "Enough is Enough!"

My pain level was hindering my ability to concentrate so much that, despite having a college education, I had to ask a friend how to spell the word "place." I could not figure out why "plase" sounded right but looked so wrong.  

The previous night, I could not even read a lesson to the teenagers at my church, despite the fact that I had taught the exact same lesson twice before -- and I was the one who wrote it.

Pain medication and procedures such as epidural nerve blocks and RFA treatments kept my pain under control for most of the past decade, until the CDC introduced its opioid prescribing guideline. As a result, I have been bedridden for most of the past month.

My pain issues began 40 years ago in my senior year of high school, when I was in a motor vehicle accident which resulted in me being thrown through the rear window of the car and landing 35 feet away on my head. The impact caused a compression fracture at the base of my neck and damage to multiple discs as well.

Within a few years, it became necessary for a neurosurgeon to cut a section out of both of the occipital nerves going up the back of my neck and into my scalp as a long-term treatment for the massive headaches I was having.

Unfortunately, the nerves grew back together after 35 years and the migraine headaches have returned --- along with nerve related pain caused by disc degeneration and arthritis.

DAVID EATON

Another auto accident 25 years ago caused my knees to slam into the hard dash of my minivan. During the ambulance ride to the hospital, the paramedics told me that I would likely be using a cane within 5 years and in a wheelchair within a decade. They were not far off. I managed to go 13 years before the pain in my knees became so severe that I could no longer climb in and out of my car or walk into the office.

Now, after being on disability for a decade, I am unable to straighten my legs. Attempting to stand, much less walk a step or two, is both excruciating and impossible.

And, if you order right now, we will include a free congenital birth defect that resulted in severe stenosis in my lower back. This was only magnified when I suffered a slipped disc 12 years ago.

It was at that time that I was referred to a pain clinic, which used a combination of medications and procedures to control my pain. Those treatments were very successful. While they did not eliminate the pain, they were at least able to keep it at a manageable level until the CDC stuck their nose between my doctor and myself.

Their guideline has resulted in some pain clinics not prescribing anything stronger than what you can get over the counter. While I am sure that part of the clinics’ decision making included the fact that they make profits off of additional office visits, as well as surgical procedures, the end result is the same: Patients are left hurting and becoming depressed to the point of suicide.  

My doctors regularly question me about suicidal thoughts, as well as a list of other mandatory questions any time I even hint at being depressed. The truth is that I am depressed and have been for quite some time, but even more so now that the pain is so much more severe.

The CDC guideline, a knee-jerk reaction to the opioid epidemic, has resulted in my daily use of extended release opioids to be cut in half. This led to a doubling of not just the amount, but the severity of my pain.

To make matters worse, a change in insurance coverage resulted in me having to be treated by a different pain clinic. The new doctor took me completely off anti-inflammatory medication for the arthritis in my back, neck and knees. The resulting pain wakes me up at the slightest movement. The pain in my knees is so excruciating when I attempt to get from my bed or recliner and into my power chair for a trip to the restroom, that that I put it off as long as I can. 

In addition, the sensory nerves in my legs are now so inflamed that I feel as if someone is stabbing me to the bone or trying to pry off one of my toenails.  I feel as if someone has poured boiling hot coffee down my legs, giving me severe burns on my thighs.

Like I said, enough is enough! I have more pain than I can handle. Something has to give and I am praying that it is a relaxation of the CDC guideline. Maybe it would help if I could get a medical transport van to carry me to the CDC so I could pour a pot of hot coffee down some guy's pants and then check the severity of his burns by repeatedly stabbing him with a meat thermometer.

David Eaton resides outside of Atlanta, GA with his wife of 36 years. He has 2 grown sons, both married, and 4 beautiful grandkids. Prior to becoming disabled, David worked in the IT field. He was also heavily involved in his church, where he taught Sunday school and served as Youth Minister.

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

The information in this column 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.

An Old Disease Returns in Modern Times

By Pat Anson, PNN Editor

Dr. Forest Tennant may no longer be practicing medicine, but he continues his groundbreaking research into the causes and treatment of adhesive arachnoiditis (AA), a chronic, progressive and painful inflammation of spinal nerves.

Once a rare disease linked in the 19th century to infections such as syphilis and tuberculosis, arachnoiditis is re-appearing in surprising numbers and for completely different reasons. Tennant believes millions of Americans may have developed AA, which is often misdiagnosed as “failed back syndrome” – chronic back pain that fails to respond or grows worse after invasive spinal procedures.

“I think it’s now the number one cause of really severe pain in the country. I don’t think there’s any question about that,” says Tennant. “When I closed my clinic, about 70% of the people in there who had to take high dose opioids had an issue with arachnoiditis.”

Tennant and co-author Ingrid Hollis have written a new book -- “Adhesive Arachnoiditis: An Old Disease Re-Emerges in Modern Times” -- to help doctors and patients recognize the symptoms of AA and to offer hope for treating a disease long thought to be incurable.

Why is AA re-emerging?  Tennant says a “perfect storm” began to appear around the year 2000, when longer lifespans, obesity and sedentary lifestyles contributed to more cases. Lack of exercise has long been associated with chronic back pain.

Arthritis, accidents, repetitive stress injuries and even Lyme disease can also cause degenerative spinal conditions that lead to AA.

“But the real factor contributing is probably sedentary lifestyles. Look at the number of people spending 6 to 8 hours a day in front of a computer or TV screen,” says Tennant. “I’m really trying to bring attention to the fact that people need to be aware that this is something that can happen because of our lifestyles.”

As more Americans sought treatment for back pain, millions were given “interventional” procedures such as epidural steroid injections and spinal surgeries – a trend that appears to have increased as opioids fell out of favor. While most interventional procedures do not result in complications, all it takes is a single misplaced needle or scalpel to damage the spinal cord and trigger a lifetime sentence of AA.

“Everybody wants to blame the epidurals and the surgeries for these problems, but they were only doing these things when there were medical indications for them. And if they do the surgeries and the epidurals, a certain percentage of them are going to get arachnoiditis,” Tennant told PNN.

“There is a risk/benefit to these procedures. If you start going in and operating on the spine or you have half a dozen epidural injections, you start increasing your risk for developing adhesive arachnoiditis. One of the points I want to make is that it is the underlining spinal conditions that are causing the problems. The interventions and the surgeries may accelerate it, but the condition was already set.”

For many years, Tennant was one of the few doctors in the U.S. willing to treat AA patients with high doses of opioids. Intractable pain patients from around the country traveled to California to see Tennant – which led to his home and office being raided by the DEA in 2017. No charges were ever filed against Tennant, but the stress of being investigated led to his retirement from clinical practice.

Tennant now consults with other doctors and is developing new protocols for treating AA with hormones and drugs that reduce pain and inflammation while stimulating nerve growth. His book includes a self-screening test for patients and a list of AA symptoms.

Most essential in any AA diagnosis is a good MRI of the spine. Tennant has a library of over 300 MRI’s sent to him by patients and doctors in dozens of countries — a testament to how AA is re-emerging worldwide.

(Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.)  

Americans More Likely To Get Opioid Prescriptions After Surgery

By Julie Appleby, Kaiser Health News

Americans and Canadians are seven times more likely to fill a prescription for opioid pain pills in the week after surgery than Swedes, says a study published Wednesday, one of the first to quantify international differences.

More than 75% of patients in the U.S. and Canada filled a prescription for opioids following four common surgeries, compared with 11% of Swedes, researchers report in JAMA Network Open. Americans also received the highest doses of opioids.

So, are Americans and Canadians wimpier than Swedes when it comes to pain, or is something else going on?

“There are a lot of tough people in lots of places,” demurred Mark Neuman, an associate professor of anesthesiology at the University of Pennsylvania Perelman School of Medicine and a co-author of the study.

He pointed to a host of other potential factors, from cultural differences to variations in marketing, regulation and long-standing, ingrained prescribing habits.

“It’s possible that in the U.S. people think about opioids as pain relief in a drastically different way than in other places,” he said.

Researchers examined four types of surgeries — minimally invasive types of appendectomy and gallbladder removal, as well as arthroscopic surgery to repair a torn meniscus in the knee and breast tumor removal. All the surgeries occurred from 2013 to March 2016, a time of growing concern about opioid dependence in the United States but before more recent guidelines suggesting that fewer pills are needed following many common surgeries.

Even so, “for the same exact surgery, the same exact tissue trauma, we have seven times more people in the U.S. getting opioids,” said Neuman.

On average, patients in the U.S. filled prescriptions for about 33 pills, each equivalent to 5 milligrams of oxycodone, he said, although the type of drug varied. Swedes who filled prescriptions had an average of 26 pills, while Canadians had 22.

Canadians and Swedes were also far more likely to get codeine or tramadol — painkillers that rely on a different mechanism in the body and are considered weaker types of opioids. Americans were far more likely to get hydrocodone or oxycodone, some of which were heavily marketed to physicians by drugmakers. States and cities are currently suing manufacturers, alleging they misrepresented the drugs’ risks and didn’t properly monitor suspiciously large sales, contributing to the opioid crisis.

The study does not comment on the marketing aspect but did note two factors that might account for some of the difference in the types of drugs prescribed. One is that, during the research period, low-dose codeine was available over the counter in Canada. Tramadol is still not classified as a controlled substance there, although it has been a controlled substance in Sweden since 2007 and in the U.S. since 2014.

“While prescribers may view these so-called weak opioids as safer alternatives, data suggests that both codeine and tramadol have the potential for misuse and life-threatening adverse effects,” the study says.

The U.S. and Canada were chosen because they have the highest per capita consumption rate of opioids in the world. Sweden was picked as a European counterpoint because researchers could obtain detailed prescription information from databases there.

While the study was large — following about 129,000 patients in the U.S. with job-based insurance, 84,600 in Canada’s Ontario province and 9,800 in Sweden — it did have limitations. For one, researchers could not track how many pills patients actually took of those prescribed, or the number of patients who didn’t fill prescriptions they were given. Secondly, they don’t have data on how well patients felt their pain was controlled following surgery.

“It’s possible that in Sweden everyone’s pain treatment is less than in the U.S., although I think that is unlikely,” said Neuman, noting that other studies have shown that patients in the U.S. often do not take all the pills they’ve been prescribed following surgeries.

Fewer Pills Being Prescribed

In addition, for certain types of surgeries, patients do not report greater dissatisfaction when prescribed fewer pills after surgery. Researchers in Michigan, for example, recently reported on what happened after dozens of hospitals recommended new prescribing guidelines — drawn up after studying how many pills patients actually took — following certain surgeries. While recommendations were often for far fewer than 30 tablets, researchers found no increase in reported pain.

Like the group in Michigan, some academic medical centers and other experts have recently issued guidelines calling for fewer pills following many procedures. Those grew out of concern that patients with what is called acute pain — the kind following surgical procedures, for example — were given far too many pills.

An analysis of Medicare data by Kaiser Health News with researchers at Johns Hopkins Bloomberg School of Public Health, for example, found prescribing from 2011 to 2016 exceeded levels now recommended by organizations like Johns Hopkins. For example, Medicare patients took home 48 pills in the week following coronary artery bypass, 31 following laparoscopic gallbladder removal, 28 after a lumpectomy and 34 after minimally invasive hysterectomies.

According to postsurgical guidelines spearheaded by Johns Hopkins last year, those surgeries should require at most 30 pills for a bypass, and 10 pills for minimally invasive gallbladder removal, lumpectomy and minimally invasive hysterectomy.

Postsurgical opioid use can lead to long-term dependency in a small but significant percentage of patients, studies have shown, but unused pills can also be a danger. Those tablets can make their way to the street or fall into the hands of other family members.

Researcher Dr. Chad Brummett, who worked on the guidelines in Michigan, said he thinks prescribing amounts in the U.S. and Canada have likely dipped in recent years, given the increased attention. Still, he cautioned that the amounts likely remain too high in both countries and that the new study illustrates the wide disparity between North America and at least one European country.

“We know that marketing in the U.S. has affected prescribing in all domains, including surgery,” said Brummett. “This study and others show that [surgeons] in the U.S. and Canada can drastically reduce prescribing standards without adversely affecting patient care.”

Kaiser Health News 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.

A Pained Life: Stop Terrorizing Doctors

By Carol Levy, PNN Columnist

When I visit chronic pain support groups online, it is almost astounding how often posters turn to talking about the “opioid crisis,” no matter the subject of the initial post. One person wrote that she lives in a town where there is not one doctor who will prescribe opioids, no matter what the diagnosis.

I see comments like, “My doctor won't prescribe them for me anymore even though they were helping,” or “My doctor reduced what I was taking without any effort to ask how I was doing.”

Often they’ll add, “My doctor said he has changed his prescribing practices because of the CDC guidelines.”

Human Rights Watch recommended last year that the CDC guideline be revised because too many doctors were using it as an excuse to abruptly cutoff or taper patients.

“Even when medical providers understood that the Guideline was voluntary, they believed they risked punishment or unwanted attention from law enforcement agencies or state medical boards if they maintained patients at high doses,” Human Rights Watch found.

How does this fear, engendered by political institutions like the CDC and DEA, not fall under the definition of terrorism? This is how Miriam-Webster defines terrorism: 

“The unlawful use or threat of violence especially against the state or the public as a politically motivated means of attack or coercion.”

Granted, the guidelines are not unlawful, but they have had the exact effect of being coercive on many in the medical community. I would also contend that the threat of being arrested and going to prison is a threat of violence.

The guidelines were engendered by the public outcry and governmental concern over the level of opioid overdoses and deaths. The CDC said the guidelines are voluntary, but to many doctors, pharmacies and insurance companies they are enshrined in stone as commandments. They were promulgated as a political response. They were not based on the medical model or the realities of patients in pain.

The point of terrorism is to instill fear. Terrorize one and others will fall in line. The guidelines have had exactly that effect. Accuse one doctor of overprescribing or running a pill mill – even if no charges are actually filed -- and other doctors will change their practices by reducing or refusing to prescribe opioids out of fear of being falsely accused, even when they know doing so will hurt their patients.

And how are patients hurt? Attorney Mark Rothstein, Director of the Institute for Bioethics at the University of Louisville School of Medicine, answers that question.

“Many physicians who previously prescribed opioids now have reduced or discontinued such prescriptions, even for established patients with chronic pain. In some cases, the change in policy was adopted literally overnight,” Rothstein wrote in the American Journal of Public Health.

“With no alternatives for pain control... and the physical and mental pressure of unremitting pain, many patients turned to illicit drugs, especially heroin. The result has been greater addiction, more deaths from overdoses, and an increase in cases of HIV/AIDS and hepatitis from contaminated syringes.”

It is long past time to end what has been interpreted as policy, a policy that hurts patients and the community. It’s time for the terrorism to stop.

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.

Does Chronic Pain Affect Memory?

By Ann Marie Gaudon, PNN Columnist

Pain is a complex experience. It not only affects us biologically, but we also experience it cognitively and emotionally. Does it affect our memory? You bet it does.

Chronic pain patients often complain of memory problems and there are numerous studies which confirm these challenges are indeed a reality.

Twenty-four studies evaluating working memory (WM) and/or long-term memory (LTM) in chronic pain groups and control groups were reviewed last year by French researchers. WM was defined as the processing and manipulation of information within a short period of time (a few seconds), while LTM involved the “storage” of knowledge and memories over a long period of time.

Concentration and memory deficits on a daily basis were the most frequently reported cognitive difficulties. Memory complaints included forgetfulness and problems performing everyday tasks and conversations.

Emotional distress common to pain patients, such as depression, anxiety and rumination (the inability to divert attention away from pain), was also found to play an important role in memory difficulties.

One study compared two groups of pain patients who had minor or major memory complaints. Between the two, no significant differences were found with regard to age, gender, education level, marital status, medication use, long-term pain or pain intensity.

However, patients in the major memory complaint group suffered from emotional distress to a significantly greater degree. They also reported a lack of family support and discontent with their social and sexual lives. These were noted as additional daily sources of suffering for this group.

Adding to potential negative effects on memory were comorbidities which many pain syndromes share. Conditions such as depression, anxiety, sleep disturbances, and chronic fatigue could alone or combined affect memory. A major concern expressed was the need to disentangle pain-related cognitive effects from those resulting from these comorbidities.

Medications and Memory

The review really became interesting when it came to medication, because researchers found contradictory results. One European study reported that opioids exerted a negative effect on working memory -- finding a clear association between higher levels of analgesics and perceived memory dysfunction in chronic back pain patients. Some studies confirmed that medication can have a negative effect on memory, but others showed improvements in memory following analgesic treatment. That suggests that effective pain relief may also reverse pain-induced memory impairment.

The researchers concluded it was unclear whether analgesic medications are beneficial or detrimental, because both scenarios were reported.

Age was also identified as an important factor in the relationship between chronic pain and memory, but not in the way you may think. Surprisingly, it was shown that an increase in age did not additionally affect memory performance.

One study reported that gender and age significantly affected memory decline in those suffering from chronic migraine headaches. Cognitive decline in migraineurs was greater among younger individuals, and females showed greater decline during headache intervals than males. It was acknowledged that gender as a factor in pain-related experience is poorly investigated.

Like all reviews, this one has its limitations. There was a “large heterogeneity” of tests within the 24 studies. This diversity of tests did not allow for a suggestion of which memory processes were altered by chronic pain itself. The study populations were also heterogeneous regarding pain etiologies and an assessment of the intensity of pain was not performed.

Studies which included a mix of chronic pain disorders did not provide data on whether specific memory impairments were more frequently observed in specific disorders. The authors suggest there is a need for comparative studies across pain-related disorders in order to determine whether impairments are pain-related or a consequence of other pathophysiological features.

These numerous studies confirmed the memory decline that is often reported by chronic pain patients. Even if these effects are mild, the impact on quality of life could be substantial as they may indeed worsen suffering including depression, anxiety, and limitations on activity.

Researchers suggested that examining memory function should be part of the clinical assessment of chronic pain patients. The spectrum of cognitive difficulties must become acknowledged and understood in order to find ways to overcome them.

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.

How Pain Patients Feel About the Opioid Crisis

By Pat Anson, PNN Editor

We received an overwhelming response from readers to Diana’s Franklin guest column on how the opioid crisis has affected her. Diana has suffered from scoliosis since she was a child and now has degenerative disc disease. For many years oxycodone helped Diana manage her chronic back pain, but she can no longer get it.

Diana considers herself collateral damage of a crisis she had nothing to do with.

“The government stopped allowing my doctor to prescribe any opioids, leaving many of his patients, including myself, without any pain medication at all,” Diana wrote.

“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.”

Diana’s story hit home with hundreds of readers who left comments or sent us emails.

“Just recently my doctor said that he was gonna have to stop prescribing me my opioid pain medication,” wrote Jeffrey Ticich, who suffers from scoliosis, stenosis, a herniated disc, and recently had his right leg amputated.

“When my doctor takes my opioid pain medication away from me, I will start looking for a burial plot. I have suffered most of my life with severe chronic acute pain and I will not suffer anymore. There has got to be a solution for patients that are suffering and not abusing their opiate pain medication.”

“I am a disabled law enforcement officer. I was hurt in a car crash years ago responding to a rape in progress. The only way I've had any quality of life is with the pain medication,” wrote a man who didn’t want his name used. “Life has been really rough since (they) restricted pain medication. Also think of all the injured veterans. What a way to say thanks for your service.”

“I've suffered with neuropathy for almost 15 years. It's very painful, especially in my lower legs. I find it difficult to even walk to the mailbox and back,” said Leslie Rowland, who is 70. “I too am a case of collateral damage when it comes to pain meds. I've loved to fish all my life but had to give it up this year due to the pain. Please, someone with a voice needs to be heard for people like me. All I want is not to be in pain 24/7 and to have a decent quality of life.”

CDC Guideline Unchanged

Many pain patients thought their voices were finally being heard last April, when CDC Director Robert Redfield, MD, acknowledged that many insurers, pharmacies, states and practitioners were implementing the agency’s 2016 opioid guideline as a mandatory policy.

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm. The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy,” said Redfield.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms.”

Five months later, not a word of the CDC guideline has changed. And many doctors, insurers and pharmacies are still reducing opioid dosages or cutting off patients.   

“My pain doctor keeps reducing my pain medicine dose to the point that it's almost ineffective, thanks to our government's unrealistic guidelines. And instead of going after the real culprits of the problem (the dealers), they're putting the blame on the doctors,” wrote Richard Parrish. “Those of us who really need help are paying the price for our inept government's prescribing guidelines. THIS HAS GOT TO STOP!”

“I have been in pain since last October from neck pain that travels to the back of my ear from whiplash,” wrote Lois Henkin. “I have been to all kinds of doctors, had physical therapy, had facet joint shots, cervical steroid shots, etc. with no change in the pain.

“I was put on gabapentin for the pain, with no results. I switched to Tramadol, which works, but now because of the opioid crisis, I am not even given 1 pill a day. This is not fair to people that have severe pain. Just limit the meds to the drug addicts.”

Many readers, like Debra Christian, said they felt abandoned and misunderstood.

“Unless you live in chronic pain, then you don't understand it, nor do you know what it does to a person and how it changes the person they were,” Christian wrote. “We don't have lives. We’re just existing.

“This is a problem. This is a travesty. This is a financial burden. And I am an American who wants to still work, but I can’t. It will be up to me to fight with whatever strength I have left, if I want any quality from my life that I and so many others deserve.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated.

Is Your Pain Medication Effective or Was It Placebo Effect?

By Dr. Lynn Webster, PNN Columnist

Most of us have been prescribed a medicine at some time in our lives. And if we got better, we probably assumed it was because the medication was effective.

However, this may not have been completely true. A positive result following the use of a medication may have little to do with the drug.

If you're a M*A*S*H fan, you may have seen an episode called "Major Topper." In that show, Colonel Potter suggests they treat people in pain with a placebo because there is a morphine shortage — and it works. Did that mean their pain wasn’t real?

Placebos Work So Well They Can Fool Researchers

One of the greatest challenges in evaluating the efficacy of medical treatments is to minimize what is known as the placebo effect. The benefit provided by a treatment during clinical trials may appear to be significant. However, the treatment may fail to be approved by the FDA if the benefits for patients who receive a placebo are too similar to those who receive active treatment.

Drug approval requires that active treatment results are meaningful and differ statistically from placebo results, even though both may provide similar outcomes when compared to a baseline. 

I study drugs for their potential to be abused— what the FDA calls a Human Abuse Potential (HAP) study. People who participate in HAP studies must admit they recreationally use the class of drug which is undergoing evaluation, and must report a strong preference for the drug when compared to a placebo.

Most people would be surprised to learn that as many as 50% of the test subjects who commonly use a drug recreationally cannot adequately differentiate between the active drug and the placebo. Even more surprising is that one in five subjects report a much greater preference or “getting high" experience with the placebo than with the active drug.

There are several reasons for this. It could be that they don’t realize researchers know which drug they received and in what order. They are simply hoping to guess correctly because they want to participate in the study. Or the subjects may be anticipating an effect that they want (to get high) and that anticipation creates the effect in the reward center of their brain without even using an active drug.

This effect is not limited to drugs. As a principal investigator in a study, I surgically implanted wires at the base of the occiput (the skull) to stimulate occipital nerves in an attempt to prevent or treat migraine headaches. Although all subjects underwent the operation and were implanted with the wires, only half received active stimulation. The other half were programmed with a sham pattern of stimulation.

When the study was unblinded, we discovered that almost everyone in both groups (active and placebo) derived remarkable, but similar, relief from the therapy.

We concluded it was their expectation that an invasive procedure would be therapeutic that provided the positive outcome. Unfortunately, the positive results of both treatment and placebo meant the new procedure could not be approved on the basis of our testing.

Placebos Work Even When People Know About Them

Ted Kaptchuk, a Harvard Medical School professor of medicine, is the director of the Program in Placebo Studies at the Beth Israel Deaconess Medical Center. In a recent episode of NPR's "Hidden Brain" podcast, Kaptchuk recounts similar results when testing the placebo effect.

However, his research added a new twist. Kaptchuk wanted to see what would happen if he used "radical honesty" to determine the potential of the placebo effect. Instead of tricking patients into believing they may receive an actual treatment instead of a placebo, Kaptchuk told his subjects they would receive a placebo. In other words, no actual drug would be administered to subjects and they were all aware of that.

Surprisingly, he found that a placebo could still work. "Hidden Brain" host Shankar Vedantam also talked to Linda Bonanno, who participated in Kaptchuk's study. Bonanno explained that Kaptchuk gave her a placebo to treat her irritable bowel syndrome and it eased the agonizing pain she had been living with for years.

The pain did not return until Kaptchuk stopped "prescribing" the placebo. For Bonanno, what seemed to help the most was the trusting relationship she had with Kaptchuk. The warmth and caring of her health care provider may have been enough to mitigate her pain.

As we know, pain isn't just a physical experience. It is a complex emotional experience that has psychological, social and spiritual elements. If a doctor's empathy, warmth, listening and caring can ease a patient's pain, that shouldn’t call into question whether the patient's pain was real. It simply makes the case that a trusting relationship with a healthcare provider is as important for successful treatment as the medication or procedure itself.  

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

Opioid Overdoses Drop, But Fentanyl Crisis ‘Likely to Get Worse’

By Pat Anson, PNN Editor

Opioid overdose deaths fell by nearly 5 percent in 25 U.S. states last year, according to a new analysis from the Centers for Disease Control and Prevention -- one of the first reports to document a significant decrease in opioid overdoses.

The 25 states covered in the report are participating in the CDC’s State Unintentional Drug Overdose Reporting System (SUDORS), which tracks overdose deaths through toxicology, medical examiner and coroner reports. SUDORS is considered more reliable than other databases because it provides more details on the types of drugs involved – both legal and illegal.

Opioid overdoses fell overall by 4.6% in the first six months of 2018, driven in large part by a 6.6% decline in deaths involving prescription opioids. The CDC found that less than a third (28.7%) of the overdoses were linked to opioid pain medication. Most overdoses involve illicit drugs.

“Prescription opioid deaths stabilized nationally from 2016 to 2017, and the number of opioid prescriptions filled has been decreasing for several years, as efforts to reduce high-risk prescribing have increased. Findings from this report suggest these efforts might have fostered decreases in prescription opioid deaths without illicit opioids,” researchers said.

While the data about prescription opioids is encouraging, the report paints a grim picture about the abuse of other substances. Nearly 63% of the opioid overdoses involved a non-opioid drug such as cocaine, methamphetamine or benzodiazepines.

Overdoses linked to illicitly manufactured fentanyl (IMF) rose by 11.1% in 2018, with fentanyl or a fentanyl analog involved in nearly nine out of ten opioid deaths.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. Fentanyl analogs such as carfentanil can be even stronger. Most drug users have no idea what they’re getting, because fentanyl is often added to heroin, cocaine and other drugs to boost their potency, or used in the production of counterfeit medication.

Fentanyl Dominates Black Market

A new report from the RAND corporation, a nonprofit research organization, suggests the fentanyl problem will be hard to eradicate. Researchers looked at synthetic opioid markets in the U.S. and other parts of the world, such as Canada and Estonia — where fentanyl first appeared 20 years ago..

“Once fentanyl gains a foothold, it appears capable of sweeping through a market very quickly,” wrote Bryce Pardo, lead author of the study and an associate policy researcher at RAND. “We know of no instance in which fentanyl attained a dominant position in the marketplace and then lost that position to another less potent opioid. To date, fentanyl’s spread appears to be a one-way ratchet.

“One of the most important — and depressing — insights in this analysis is that however bad the synthetic opioid problem is now, it is likely to get worse before it gets better.” 

RAND researchers say the surge in fentanyl and other synthetic opioids is driven by supply-side factors more than user demand. China's pharmaceutical and chemical industries are poorly regulated, allowing producers to cheaply produce fentanyl and ship it to buyers anywhere in the world. Mexican drug traffickers smuggle most of the fentanyl that enters the U.S., although some of it is shipped in the mail or by commercial delivery services.

DEA IMAGE

Unconventional strategies may be needed to address the fentanyl crisis. The RAND researchers advocate several innovative approaches, such as supervised drug consumption sites, creative supply disruption, drug product testing, and heroin-assisted treatment, which is available in some countries. Sweden has developed an online market with fentanyl analogs sold primarily as nasal sprays.

"It might be that the synthetic opioid problem will eventually be resolved with approaches or technologies that do not currently exist or have yet to be tested," said Beau Kilmer, study co-author and director of the RAND Drug Policy Research Center. "Limiting policy responses to existing approaches will likely be insufficient and may condemn many people to early deaths."

RAND researchers say there is little reason to believe that tougher sentences, including homicide laws for low-level drug dealers and couriers, will make a difference.

Last week the Mexican navy found over 25 tons of powdered fentanyl on a Danish ship docked at a Mexican port, one of the largest fentanyl shipments ever seized. The shipment originated from Shanghai, China.

Chinese officials are pushing back on claims that they’re not doing enough to stop fentanyl exports, saying the U.S. needs to stop blaming other countries for its own drug problems.

“A small group of people produce fentanyl illegally in China and mail them to the U.S. and other regions, driven by the exorbitant profit and at the request of criminals overseas, including those in the U.S. The Chinese government has zero tolerance for this. Once we find clues, we chase them down and spare no one,” Liu Yuejin, deputy head of the China National Narcotics Control Commission, told Bloomberg.

“I think the most important thing for U.S. politicians is to face the reality: What’s the root cause of such large-scale abuse of fentanyl in the U.S.? They need to find out and come up with solutions.”