CDC Study Finds ‘No Significant Change’ in Use of Rx Opioids

By Pat Anson, PNN Editor

A new study by CDC researchers has a surprise finding, concluding that there has been “no significant change in the use of prescription opioids” over the past decade by U.S. adults.

The study is based on the National Health and Nutrition Examination Survey, in which a nationally representative sample of nearly 20,000 adults is asked every two years about their healthcare and nutrition.

Although the number of opioid prescriptions in the U.S. has dropped 43% since their peak in 2011, the survey found that the use of opioid medication hasn’t changed much at all.  

In 2017–2018, the survey found that 5.7% of U.S. adults used one or more prescription opioids in the past 30 days, compared to 6.2% of adults a decade earlier.

“Between 2009–2010 and 2017–2018, no significant trend in the use of prescription opioids was observed; however, an increasing trend in the use of nonopioid prescription pain medications without prescription opioids was seen,” researchers found.

USE OF PRESCRIPTION PAIN MEDICATIONS BY U.S. ADULTS

SOURCE: CDC

In 2017-2018, women (6.4%) were more likely to be prescribed opioids than men (4.9%). The use of opioids increased with age, from 2.8% among young adults aged 20–39 to 8.2% for those aged 60 and over.

The use of opioid prescriptions was highest among whites (6.4%), followed by blacks (5.2%), Hispanics (3.4%) and Asian adults (1.4%).

The survey did not ask respondents about the dose of opioids they were prescribed, which may account for the discrepancy with other prescription drug databases.    

A 2018 study by the health analytics firm IQVIA found a significant decline in the number of high dose opioid prescriptions of 90 MME (morphine milligram equivalent) or more. But low dose prescriptions of 20 MME or less remained relatively stable.

While the percentage of Americans using opioid prescriptions has remained relatively flat over the past decade, according to the survey, there was a notable increase in the use of non-opioid prescription pain relievers, which rose from 4.3% in 2009-2010 to 5.7% in 2017-2018.

Migraine drugs, COX-2 inhibitors, and non-steroidal anti-inflammatory drugs (NSAIDs) were classified in the survey as non-opioid prescription pain relievers, but anti-depressants and anti-convulsants were not – even though they are increasingly used to treat pain. The IQVIA study found 67 million prescriptions for the anti-convulsant medication gabapentin (Neurontin) in 2018 — a fact that is not reflected in the CDC findings.

The CDC is currently preparing an update of its controversial 2016 opioid guideline, which has been widely adopted as policy by other federal agencies, states, insurers, pharmacies and many doctors — who have used it as an excuse to take people off opioids or greatly reduce their doses.

The updated guideline – which is expected in late 2021 -- is likely to expand the CDC’s recommendations to include the use of opioids for treating short-term acute pain.

Can a Cuddly Robot Reduce Pain and Increase Happiness?

By Pat Anson, PNN Editor

A cuddly therapeutic robot – designed to look and act like a baby seal – can improve mood and reduce moderate to severe pain in people, according to a new study.

The PARO robot emits seal-like sounds and moves its head and flippers in response to being touched and spoken to. Since its introduction in Japan in 2005, the PARO has become a virtual pet for thousands of people around the world who live in places where real animals are not allowed, such as nursing homes, elder care centers and hospitals.

Since social contact between humans can alleviate pain, researchers at Israel’s Ben-Gurion University (BGU) designed a study to see if the PARO robot could have similar effects in 83 healthy young volunteers.

It’s important to note that anyone with acute or chronic pain was disqualified from participating in the study. Pain was induced in the volunteers by exposing them to a heat probe.

Those who were allowed to touch and pet the PARO rated their pain levels significantly lower than those who had no physical contact with the robot. They also reported significantly higher levels of happiness.

SCIENTIFIC REPORTS

“Another possible explanation of our finding is that the interaction with PARO distracted the participants away from pain. Changing the focus of attention away from painful stimuli was shown to be efficacious in altering pain perception,” wrote lead author Shelly Levy-Tzedek, PhD, who heads the Cognition, Aging & Rehabilitation Laboratory at the Ben Gurion University.

"These findings offer new strategies for pain management and for improving well-being, which are particularly needed at this time, when social distancing is a crucial factor in public health."

To their surprise, BGU researchers also found lower oxytocin levels in those who interacted with PARO compared to those in a control group who did not meet the robot. Oxytocin is known as the “love hormone" because it is elevated in romantic partners or mothers bonding with their children -- so a lower level of oxytocin wasn't expected.

Researchers speculated in the journal Scientific Reports that oxytocin could also be a stress marker and that lower levels of the hormone may facilitate trust and sociability.

“In summary, this study indicates that social touch with PARO robot alleviates pain, increases happiness state and decreases oxytocin levels. Participants with higher perceived ability to communicate with PARO display greater pain alleviation as well as lower oxytocin levels,” researchers said.

A 2017 study also found that touching can have an analgesic effect. Young healthy couples who held hands while being subjected to mild heat felt less pain than those who were not touching or sitting in separate rooms.  

You Can Get PTSD From Poor Healthcare

By Barby Ingle, PNN Columnist

I thought I would be a cheerleader and coach my whole life... and I will, just not physically.

I had to adapt the mental aspects of cheerleading to living with Reflex Sympathetic Dystrophy (RSD), so I found a way to keep cheering despite my physical disabilities. I also had to deal with post-traumatic stress disorder (PTSD) caused by poor treatment from medical providers.

Most people think of PTSD as something people develop during service in the military or in other stressful jobs. But PTSD can come from other traumatic situations, including chronic illness.

According to McMaster University, up to 60% of patients discharged from an ICU will suffer from PTSD. Symptoms can appear months after being hospitalized and may include anxiety, trouble concentrating, recurring flashbacks and nightmares.

My long-term providers have been great, but if I didn’t learn to get my emotions under control (mostly sadness from what I had lost due to RSD), I would not have gotten the care that I needed. I had to have a plan, stay organized, and on-topic when I went to the doctor.

Those are some of the lessons I’ve learned that help me cope with PTSD. I also get psychological help when I need it, rather than avoid the emotional stress, anger, fear and anxiety. I am not perfect at this. but I do recognize that I have PTSD and knowing it is half the battle.

It is important when setting your expectations as a patient to know if your provider is willing to add new treatments and procedures to their practice, so they can grow with your needs. Many providers will only suggest a single treatment because they make a living on that one option.

If they don’t like an alternative treatment, you may hear them say things like, “There is not enough evidence for that” or “You’ll have to do this before we can do that.”

Don’t get mad if your provider doesn’t offer a specific treatment that you want. Find one who does. Creating a supportive medical care team takes time, respect and trust in all of your providers. It is up to the patient to make their team, be involved with their care, and find the right providers.

The healthcare system in the United States is primarily set up for acute care, so navigating your way through it can be a challenge when living with a chronic or rare condition. Americans are taught as children to trust and believe in the white coats. You break a bone, get a strep throat or need stitches, you go to the doctor, get treated and leave.

I had to learn that's not always true when it comes to chronic conditions. Some ER providers don’t know how to help a chronically ill person in an acute care situation. They’re taught to take care of mental health concerns first, then physical ones.

When I changed how I talked with providers and stayed on track for the reasons I was there, I got better treatment. It took me almost three years to figure that out, but it is always possible to learn the tools and grow.

Here are four tips about going to the ER if you have PTSD from poor medical treatment.

1. Set good expectations for yourself and have a flexible plan in place. If they don’t provide the treatment you need, go to another hospital without a fight or confrontation.

2. Become aware of what they're saying and doing around you. Make a video or audio recording if that is allowed in your state. You can use it for documentation and to review later.

3. Improve your sense of self by knowing as much as you can about your chronic condition. Providers will notice if you are knowledgeable.

4. Keep it simple when dealing with the provider. Just like at a business meeting, if you put too many action items on the agenda, people will tune out or be overwhelmed.

Another tool is to learn about PTSD, how to avoid it, and about being gaslighted for having a chronic illness. Gaslighting is when someone tries to manipulate you and make you doubt yourself in order to do something that they want. I have been successful at skipping the gaslighting over the years. I think others can too, if they have the right tools.

As a patient, you can take control. I approach my healthcare with the attitude that providers are tools for me and that I am responsible for my own care. Being in control can help prevent PTSD and a host of other problems.

Don’t get mad. Go to another provider until you find the care you need. Especially when you feel wronged or not heard.

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. 

What Pain Rules Are You Following?

By Ann Marie Gaudon, PNN Columnist

As part of his pioneering work on behavioural analysis, psychologist B.F. Skinner coined the term “rule-governed behaviour” in 1966.

We all live by rule-governed behaviours, they’re part of our learned history. For example, a young child can be told “never touch a hot stove” and they will not. Most people don’t need to suffer the consequence of being burned by a hot stove because we are able to learn the lesson from our language abilities.

Other rules may include judgments about ourselves, our environment and about others, which can lead to behaviours that make our lives more -- or less -- enjoyable.

When living with chronic pain, our minds give us no shortage of rules. Creating rules about pain is one way that our minds process and react to it. Why? It’s because our minds are always trying to protect us, to keep us safe, alive and as pain-free as possible..

However, the mind doesn’t discriminate and can be maladaptive. Some rules will be very helpful (“I must avoid certain foods due to colitis”) and some will be completely arbitrary and unhelpful (“I must avoid all types of exercise because of a torn rotator cuff”).

The problem with buying into some rules, or treating them as if they were the literal truth, is that we find ourselves going over the same self-defeating tracks over and over again. One simple sentence can take on colossal dimensions.

“Beth” will be our pain patient of the day. She has a torn rotator cuff and has taken on the sole identity of “chronic pain patient” to the exclusion of all other roles in her life. It’s become a real problem. Take a look at the rules Beth has developed for herself due to chronic pain:

“I can’t work if I’m in pain.”

“Feeling pain is unacceptable. I can’t live a good life with that feeling.”

“It simply isn’t fair that I should suffer with this.”

“Exercising will make the pain worse.”

As a result of Beth buying into these rules, what do you think her life has become? If you think that Beth has locked herself up tightly in a “pain chain,” then you are correct. Her suffering has gotten worse from this type of “dirty pain.”

You may have noticed that some of Beth’s rules are patently absurd. There is no fault to be found here. Our minds are rule makers and problem-solving machines – even when the problem is thus far unsolvable (chronic pain). Beth is not yet aware of how her mind’s reactions to her pain are choking off her life, and not yet aware that there are strategies to help her free herself.

As a professional therapist, I would not be telling Beth her rules are true or false, and I would encourage her to do the same. That self-argument would be unproductive: “I am unlovable”…”Yes I am lovable”… “No I am not”… and so on.

A debate like that is not helpful. Instead, I would be asking Beth questions in an attempt to put some metaphorical space between her and her maladaptive rules. You can ask yourself these same questions about your own limiting rules.

Can you identify your overall pain rule and can you name it? Nothing can be done about these restrictions until you become aware of them and can identify them yourself.

Do you notice what happens when you follow this rule? It is highly likely that when you follow the rule your anxiety and distress will go down in the short-term. However, in the long-term, your behaviour will become more and more rigid. You will have much less choice in your life and move far away from a life that you value. Relationships with yourself and others will pay a high price. Your suffering will increase exponentially.

Can you look at this rule in terms of workability? If you continue to follow this rule, is this a workable solution to your suffering? Will this be helpful to you to live a richer, more meaningful life? Are the long-term costs worth the short-term payoff?

Are you prepared to make a choice?  You cannot stop the rule from popping into your mind, but you do have a say in how you respond. Will you follow this rule or choose to do something different? Will you bend or change the rule? Will you be flexible?

Do you notice what happens with your choice? If you choose to follow the rule, where does that take you? If you choose something different, where does that lead to?

This type of self-exploration would be a first step in addressing Beth’s restrictive rules and the consequences of blindly following them. Learning to choose new rules to influence her behaviour is akin to laying down new tracks over the old detrimental ones.

Beth will do well to acquire all of the tools she can to help her to live a better life, alongside the challenges she faces from chronic pain. Psychotherapy is one of those tools.

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. 

AMA: ‘CDC Guideline Has Harmed Many Patients’

By Pat Anson, PNN Editor

The American Medical Association is urging the Centers for Disease Control and Prevention to make significant changes to its 2016 opioid prescribing guideline to protect pain patients from arbitrary limits and other restrictions on opioid medication.

“It is clear that the CDC Guideline has harmed many patients,” the AMA said in a 17-page letter to the CDC.

The letter was in response to the CDC’s request for public comment as it considers an update and expansion of its controversial guideline. The guideline was only intended for primary care physicians treating chronic pain, but the CDC’s voluntary limits on opioid prescribing have been widely adopted as strict policy by federal agencies, states, insurers, pharmacies and doctors of all specialties.

The guideline has also failed to end the so-called opioid epidemic, which is now largely fueled by illicit fentanyl and other street drugs.  

“The nation no longer has a prescription opioid-driven epidemic. However, we are now facing an unprecedented, multi-factorial and much more dangerous overdose and drug epidemic driven by heroin and illicitly manufactured fentanyl, fentanyl analogs, and stimulants. We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens,” wrote AMA Executive Vice President and CEO James Madara, MD. 

“The nation’s opioid epidemic has never been just about prescription opioids, and we encourage CDC to take a broader view of how to help ensure patients have access to evidence-based comprehensive care that includes multidisciplinary, multimodal pain care options as well as efforts to remove the stigma that patients with pain experience on a regular basis.”

Over 5,300 public comments were submitted to the CDC, most of them from patients who blame the agency for their untreated and poorly treat pain. Tuesday was the deadline for comments to be submitted.

One-Size-Fits-All Restrictions

The AMA’s letter points out that opioid prescriptions were declining long before the CDC guideline was released, falling 33% from 2013 to 2018.  

Many patients cutoff from opioids have had no effective alternatives for pain relief. Some non-opioid therapies recommended by the CDC – such as massage and meditation – are still not fully covered by insurance.    

“In many cases, health insurance plans and pharmacy benefit managers have used the 2016 CDC Guidelines to justify inappropriate one-size-fits-all restrictions on opioid analgesics while also maintaining restricted access to other therapies for pain,” Madara wrote. 

The CDC plans to update and expand its guideline to include recommendations for treating short-term acute pain and tapering patients safely off opioid medication.

Madara said the agency should start by recognizing that pain patients need individualized care, not “one-size-fits-all algorithms and policies that do not take individual patient’s needs into account.”   

“Some patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than guidelines or thresholds put forward by federal agencies, health insurance plans, pharmacy chains, pharmacy benefit management companies, and other advisory or regulatory bodies,” Madara said. 

The AMA said the CDC Guideline could be substantially improved in three ways:  

1. Acknowledge that many patients experience pain that is not well controlled, impairs their quality of life, and could be managed with more compassionate patient care.  

2. Make the guideline part of a coordinated federal strategy to ensure patients receive comprehensive pain care delivered in a patient-centered approach.  

3. Urge states, insurers, pharmacies and other stakeholders to immediately suspend use of the CDC Guideline as an arbitrary policy to limit, discontinue or taper a patient’s opioid therapy. 

The CDC has been slow to respond to criticism of its 2016 guideline. The agency ignored an early warning from a consulting firm that many patients are “left with little to no pain management options” because “doctors are following these guidelines as strict law rather than recommendation.” The warning came in August 2016, five months after the CDC released its guideline.

It took the agency another three years to publicly admit that many patients were being tapered off opioids inappropriately, putting them at risk of uncontrolled pain, withdrawal and suicide. The agency’s long awaited “clarification” in 2019 had little impact on the problem, because many insurers, pharmacies and doctors still adhere to strict dosing policies. 

Even now, the agency appears to be dragging its feet on making revisions to the guideline, which seem more focused on expanding the recommendations rather than fixing them. The CDC does not anticipate the updated guideline to be ready until late 2021.   

New Drug Relieves Back Pain, But Safety Issues Remain

By Pat Anson, PNN Editor

An experimental non-opioid pain reliever gives long-term relief for chronic low back pain, but questions remain about joint damage and other side effects from the drug, according to a large new study.

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein in the blood that heightens pain sensitivity. Tanezumab binds to NGF and inhibits pain signals from reaching the brain.

In a Phase III study of over 1,800 patients with difficult-to-treat low back pain, participants given an injection of tanezumab once every two months had significantly more pain relief than those given tramadol or a placebo. The study was funded by Pfizer and Eli Lilly, which have spent nearly a decade jointly developing tanezumab as an alternative to opioid medication.

"This demonstration of efficacy is a major breakthrough in the global search to develop non-opioid treatments for chronic pain," said lead author John Markman, MD, director of the Translational Pain Research Program at the University of Rochester Medical Center. "There were also improvements in function linked to the reduction in pain severity."

But this “major breakthrough” is tainted by the fact that about 10% of patients given 10mg of tanezumab had joint pain or other side effects. Seven of them needed total joint replacement surgery. Patients who received 5mg injections of tanezumab had fewer side effects, but less relief from back pain.

NGF inhibitors have previously been linked to a rapidly progressive form of osteoarthritis. But researchers say other methods of treating back pain, such as opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and surgery, have their own safety risks.

"In the future, clinicians may have to weigh the different risks of lumbar fusion surgery, chronic opioid use, or NSAIDs against the unique risks of a rare but rapidly progressive form of joint problem associated with blocking nerve growth factor," said Markman. "I expect that that the tradeoffs between benefit and risk will be different for osteoarthritis than for chronic low back pain."

Tanezumab is currently under review by the Food and Drug Administration as a treatment for moderate-to-severe osteoarthritis (OA), with a decision expected late this year. In a 2019 study of osteoarthritis patients taking a 5mg dose of tanezumab, there was significant improvement in their pain and physical function. But about 6% experienced rapidly progressive osteoarthritis.

Pfizer and Eli Lilly are not currently pursuing tanezumab as a treatment for chronic low back pain (CLBP).  

“Pfizer and Lilly made the decision to prioritize OA based on an assessment of the totality of SC tanezumab data and an initial discussion with the FDA,” a Pfizer spokesman said in an email to PNN. “At this time, regulatory submissions are not planned for tanezumab in patients with moderate-to-severe CLBP. Additional data analyses, and potentially further clinical study, may be required to more fully characterize tanezumab in CLBP patients.”

The new study was published in the journal Pain. Some of its findings had previously been released by Pfizer and Lilly.

New Treatment Significantly Reduces ‘Frozen Shoulder’ Pain

By Pat Anson, PNN Editor

Preliminary results from a small study show that an experimental treatment for adhesive capsulitis -- also known as “frozen shoulder” – dramatically reduces pain and quickly improves function in patients.

Frozen shoulder occurs when ligaments and connective tissues surrounding the shoulder joint become sore and inflamed. The inflammation gets so painful that many patients have difficulty using their arms. The resulting lack of use makes the shoulder joint even more stiff and inflamed – a vicious cycle that “freezes” the shoulder in place.

About 200,000 people annually in the U.S. develop frozen shoulder, mostly middle-aged adults. Several years ago, I was one of them. The pain was so bad at times, it felt like someone whacked me in the the shoulder with a baseball bat. I had trouble putting on a shirt or sleeping in the same position for more than a few hours.

Frozen shoulder is usually treated with physical therapy, massage, joint injections or pain medication, until the symptoms resolve in a few months or perhaps even years. Thankfully, that’s what happened to me. More serious cases can result in rotator cuff surgery.  

Researchers at the Vascular Institute of Virginia used a less invasive procedure called Arterial Embolization of the Shoulder (AES) to reduce blood flow into the shoulder of 16 patients with adhesive capsulitis. Physicians inserted a catheter through a pinhole-sized incision in the patients' wrists that was used to feed microscopic particles into six arteries leading into the shoulder.

"Patients with frozen shoulder are essentially told to tough it out until their symptoms improve, but considering the significant pain and decreased function many experience, we looked to determine if this treatment model of embolization, already in use in other areas of the body, could provide immediate and durable relief," said lead author Sandeep Bagla, MD, director of interventional radiology at the Vascular Institute of Virginia.

It may sound counter-intuitive, but decreasing the flow of blood into shoulder tissue significantly reduced the patients’ pain and inflammation.

"We were shocked at the profound and dramatic improvement patients experienced in pain and use of their shoulder," says Bagla. "We are early in the investigation of this treatment but are inspired by its effectiveness in reducing pain and range of motion in patients' shoulders."

The treatment was conducted on an outpatient basis and takes about one hour. Nine patients reported minor side effects such as skin discoloration.

The findings were recently presented in a research abstract during a virtual session of the Society of Interventional Radiology. The authors note that AES is still investigational and that conservative therapies for frozen shoulder should still be considered first.

‘You Ruined My Life’: Patients Blame CDC for Poor Pain Care

By Pat Anson, PNN Editor

Nearly 5,400 people have left comments in the Federal Register sharing their experiences and concerns about the quality of pain care in the United States. Tuesday was the final day for people to make public comments, which the Centers for Disease Control and Prevention will consider as it updates and possibly expands its controversial opioid prescribing guideline.

Most of the respondents are patients who blame the CDC for their poorly treated or untreated pain. Although the 2016 guideline was only intended for primary care physicians treating chronic pain, the CDC’s recommended limits on opioid prescribing have been widely adopted as policy by federal agencies, states, insurers, pharmacies and many doctors — who use the guideline as excuse to take people off opioids or greatly reduce their doses.  

“The day the CDC guidelines came out, I was taking 400mg oxycodone and leading a productive life. Then I was taken completely off all my medication. I went through hell and wanted to kill myself,” wrote Wren Lum. “I lost my job because I couldn't work anymore. I could no longer get out of bed. Lost my house because I could no longer pay the mortgage. CDC, you ruined my life.”

“I am not being prescribed the right dose of pain medication and it’s all because of the CDC guidelines. I used to be on three times the amount of oxycodone that I am now on and it’s taken away my ability to walk. I’m only 34 years old. This is devastating to me and my family, and now have such a lack of quality of life,” wrote Holly Letendre.

“I was given opioid medicine for 8 years. I could work, volunteer, socialize, care for my children, my husband, my home, and importantly, myself. I now shower every 10-14 days, it's too painful. When I do, I am curled up in horrendous pain for hours afterwards,” said Donna Johnson. “This is due to the CDC’s guidelines. It was then that doctors became afraid to prescribe, even to compliant patients living happy lives. I want my life back.”

The CDC is planning to update or expand the guideline to include recommendations for treating short-term acute pain and tapering patients safely off opioid medication. It took the agency three years to acknowledge that some patients were being taken off opioids too rapidly, putting them at risk of withdrawal, uncontrolled pain and suicide.

“My life has become miserable. I suffer every day after my doctor cut my dosage by almost 90 percent. Ninety percent! My blood pressure meds have had to be tripled. I have gained weight since I am now for all intents and purposes nearly bedridden,” said Kendal Rice in her comment to the CDC. “You people are just monsters. Every one of you. You certainly are not healers.”

PROP ‘Urgent Action Request’

Thousands of people – mostly pain patients and their loved ones – left comments critical of the CDC guideline. That prompted anti-opioid activists to launch their own campaign in support of the agency.

Dr. Andrew Kolodny, founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), emailed an “urgent action request” to supporters last night, urging them to leave their own comments. He claimed without any evidence that the backlash against the CDC was bankrolled by drug companies.

“The CDC has been receiving pressure to weaken the recommendations in its 2016 CDC Guideline,” wrote Kolodny. “Not surprisingly, much of this pressure is coming from pain organizations funded by drug companies and from opioid-dependent pain patients. Many of these patients are fearful and angry because they're having a harder time finding clinicians willing to prescribe opioids aggressively.” 

In a joint letter to CDC Director Dr. Robert Redfield, Kolodny and several PROP members said the guideline was “tremendously helpful” to primary care physicians and has led to “downward trends in inappropriate prescribing.” The letter also claimed that long term use of opioids often makes pain worse and leads to “intolerable negative mood changes” in patients. 

“We know from clinical experience and from controlled studies that opioids are rarely beneficial for chronic pain,” Kolodny wrote. “Now is not the time to reverse the gains of the 2016 guideline. The focus now should be twofold: to find better ways to help people already on opioids and improve access to better means than opioids to treat chronic pain.” 

Alternative Treatments

Many patients say they’ve already tried non-opioid treatments and found them ineffective for severe pain. 

“The majority of antidepressant and anti-seizure medications available today pose just as much a risk for dependency, withdrawal and death as opioids, if not more. Yet these medications are prescribed 1,000 times more and have much more severe side effects and withdrawal effects,” wrote Lois Luesing, who says her 36-year old son is housebound and unable to work because of chronic pain.

“He’s tried numerous available Rx meds, creams, alternative treatments, supplements, patches, etc. and nothing works. The only medication that will work to relieve his pain and give him his life back are opioids, yet we can’t find a doctor to prescribe this life-saving medication for him. It’s not his fault that’s the only thing that works. There are millions of others that this is the same for.”

Some patients have found alternatives that do work.  Although the herbal supplement kratom isn’t even mentioned in the CDC guideline, hundreds of kratom users left comments in the Federal Register asking the CDC not to regulate kratom.  

“Kratom is a life saver for me. I was being personally prescribed opiates for almost 20 years due to chronic pain. Although I always took as directed and never let them ruin my life, there's a very fine line to not go over the edge with them. They are so addictive and pretty dangerous for that matter. Since finding kratom this past year, I've been able to stop taking the opiates,” wrote Michael B. “Please don’t take this wonderful plant away from us. I assure you it will end up destroying many people's lives.” 

An update to the CDC guideline is not expected until late 2021, nearly six years after the initial guideline was released.  The agency has funded a series of new studies on opioid and non-opioid treatments for chronic pain.

The report on opioids was released in April. It concluded that opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose.

‘Golden Era’ for Migraine Therapy Not Providing Relief

By Pat Anson, PNN Editor

In recent years there have been many advances in treating and preventing migraine – what some have called a “treatment revolution” in migraine therapy. New oral and injectable drugs block a key protein released during migraine attacks, and a novel smartphone-controlled device uses neuromodulation to help ease migraine pain.

But for many migraine sufferers, the increasingly crowded field in migraine therapy isn’t translating into pain relief or improved quality of life. Many are reluctant to seek treatment or take medication, and feel stigma about having the disease, according to two new studies.

“We are in a golden era for migraine care with the introduction of new therapeutic options for both the acute and preventive treatment of the disease, but if we don't address the need for better education, less stigma and improved access to care, we are falling short," said Eric Pearlman, MD, a senior medical director at Eli Lilly.

A survey released by the National Headache Foundation in recognition of Migraine and Headache Awareness Month found that less than a third (29%) of people with migraine feel that their disease is under control. The online survey of over 1,000 men and women diagnosed with migraine was funded by Biohaven Pharmaceutical.

Many respondents are concerned about side effects from the medications they take, such as brain fog, fatigue and sleepiness. Almost half of respondents (47%) between the ages of 18-59 say side effects have interfered with their ability to go to school or work. Nearly as many (46%) feel anxious about taking medication.

And despite the plethora of new choices available in migraine therapies, nearly two-thirds (65%) of migraine sufferers are still using an old medication -- triptans -- as a treatment for migraine pain.

"We must strive to understand and educate about the impact of this disease on not only physical well-being; but also, emotional and mental health," said Mary Franklin, executive director of National Headache Foundation. "Every person living with migraine has a different experience and we want all to feel confident in their treatment choices; but also know that there are others who understand the real impact of the disease."

The survey asked migraine sufferers about the emotional and mental burden of the disease, and the impact it has on daily life.

• 77% said they were not able to do the things they wanted to because of migraine attacks 

• 54% feared they were a burden to family, friends and colleagues

• 53% say they modified career plans due to migraine

• 42% were unable to exercise or engage in physical activity

• 37% feel less productive at work or school

• 28% feel less able to take care of their children

• 25% avoid sexual intimacy

The vast majority of respondents (93%) feel misunderstood and that those who don't suffer from migraine don't understand the severity of their disease.

OVERCOME Study

Results from the Biohaven survey were echoed in a large new study of more than 21,000 people living with migraine, which found that less than 30 percent are taking a recommended prescription medication.

"For millions of people living with migraine, the journey to an appropriate treatment program is fraught with gaps," said Susan Hutchinson, MD, scientific advisor to the OVERCOME study. "There are a variety of reasons at play, but it begins with the fact that many may not realize what they are experiencing is a migraine and not just 'another bad headache.'”

The OVERCOME (Observational Survey of the Epidemiology, Treatment and Care of Migraine) study was funded by Eli Lilly. It sought to assess the impact of new treatment options and whether migraine sufferers completed three critical steps in migraine management:

1. Actively sought care with a healthcare professional

2. Received a migraine diagnosis

3. Took a recommended prescription medication

Less than two-thirds (63%) of those who may benefit from acute migraine medication sought treatment from a healthcare provider. Of those, 75% were diagnosed with migraine. Among the diagnosed population, only 59% percent took a recommended drug. Overall, only 28 percent completed all three steps to appropriate care.

The results weren’t much better for OVERCOME respondents who may benefit from a migraine prevention drug. A little over two-thirds (69%) sought care and 79% received a migraine diagnosis. Of those who sought care and received a diagnosis, only 28% wound up taking a preventive medication for migraine. Overall, only 15 percent of this population completed all three steps to appropriate care.

Some migraine sufferers only seek treatment when their pain become unbearable. About 10% of respondents sought care in an emergency room or urgent care clinic setting, where they are less likely to receive an accurate diagnosis or take a recommended medication. 

"Even in light of recent new treatment options in the field of migraine, we still face an uphill battle as too many continue to be underserved," said Robert Shapiro, MD, a scientific advisor to the OVERCOME study. "An important aspect of migraine care that is truly diminished and may contribute to these findings is the stigma felt by many living with the disease. A person's reluctance to seek care or take medication for their migraine can be rooted in the fear of how a friend, employer, or even a loved one may view them for doing so."

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses.

Patients Recover Sooner from Minimally Invasive Back Surgeries

By Pat Anson, PNN Editor

A new study comparing short-term outcomes of minimally invasive lumbar decompression surgeries to minimally invasive spinal fusions found no significant difference in the amount of time patients needed to return to work. But decompression patients were able to drive and stop taking opioid pain medication sooner than the fusion patients.

Researchers at Hospital for Special Surgery (HSS) in New York City found that it took 117 decompression patients a median of three days to discontinue opioid medication, while it took a median of seven days for 51 spinal fusion patients.

It took 88 decompression patients a median of 14 days to resume driving, while it took 18 days for 45 fusion patients.

The findings are noteworthy, according to Sheeraz Qureshi, MD, an HHS spine surgeon, because a standard open spinal fusion generally entails a much longer recovery and slower return to activities than a standard lumbar decompression.

“Our study is the first of its kind to look at return to activities and discontinuation of narcotic pain medication after single-level lumbar decompression or single-level lumbar spine fusion performed with a minimally invasive technique,” said Qureshi, who was senior investigator for the study.

“All the patients in both groups were able to resume driving and return to work within three weeks of surgery. When you compare this time frame to that of standard open spinal fusion surgery, it’s really striking. Patients having a standard spinal fusion could take six months or longer for a full recovery.”

Degenerative conditions of the lumbar spine, such as a herniated disc or spinal stenosis, are common causes of chronic back pain. Patients may consider surgery when conservative treatments such as medication and physical therapy fail to provide relief.

Lumbar decompression surgery involves the removal of a small section of bone or part of a herniated or bulging disc that is pressing on a nerve. Spinal fusion is more extensive surgery, and is performed to stabilize and strengthen the spine. Surgeons join two or more vertebrae together, sometimes using screws and connecting rods.

In recent years, minimally invasive (MI) spine surgery has gained in acceptance and popularity. The technique uses smaller incisions than standard surgery and aims to minimize damage to nearby muscles and other tissues.

Although MI decompressions and MI fusions use the same initial approach to reach the spine with the same size incisions, the fusions are still more extensive surgeries, so pain medication may be needed for a longer period of time, according to Dr. Qureshi.

This study findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

FDA Targets Websites Selling Illicit Opioids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is trying to put more teeth into efforts to stop the sale of unapproved or misbranded opioid medications online.

The FDA has launched a pilot program with the National Telecommunications and Information Administration (NTIA) that could result in online pharmacies being blocked or having their domain names suspended for selling illicit opioids. The NTIA is a branch of the U.S. Commerce Department that is responsible for telecommunications and information policy issues.

Under the pilot program, the FDA will notify three internet registries – Neustar, Verisign and Public Interest Registry – when the agency sends a warning letter to a website operator for selling opioids illicitly and the operator does not respond adequately within the required time frame. The internet registries could then voluntarily block or suspend the website domains, which would effectively take them offline.

“Stopping abuse of illegal opioids, including those sold online, has been one of President Trump’s top health priorities. The men and women of FDA have worked tirelessly over the years with the private sector and federal partners, like NTIA, to fight illegal online opioid sales,” Health and Human Services Secretary Alex Azar said in a statement.

For now, according to an FDA spokesperson, the pilot program will not target websites selling kratom, an herbal supplement that the agency considers an opioid.

“Websites selling kratom are not being included in this pilot at this time,” the spokesperson said in an email to PNN. “FDA continues to express concerns about kratom, which affects the same opioid brain receptors as morphine and appears to have properties that expose users to the risks of addiction, abuse, and dependence.”

In recent years, the FDA has sent hundreds of warning letters to rogue online pharmacies that sell counterfeit drugs or illegal medication. When they are caught, the websites often reappear under new domain names or move offshore.

‘Our Best Selling Product’

Sometimes the letters are simply ignored. For example, in September 2019, the FDA sent a warning letter to Euphoria Healthcare, which operates an online pharmacy called “Generic Wellness.” The letter warned Euphoria about selling the opioid tapentadol under the name “Aspadol” – a generic version of Nucynta. The FDA considers Aspadol to be an unapproved and misbranded drug, and gave Euphoria 15 days to respond to the letter or face possible civil or criminal charges.

Nine months later, Generic Wellness not only continues marketing Aspadol, it calls the drug “our best selling product” and claims the company is a “well known online pharmacy for selling FDA approved high quality generic medicines.”

The FDA had better luck with a March 2019 warning letter to the online pharmacy “The Don Rx” for selling misbranded versions of the opioid tramadol. That website has apparently been blocked or is no longer operating.  

The FDA’s new pilot program is apparently the result of meetings the agency had with internet stakeholders and registries to discuss ways to collaboratively stop sales of illicit opioids online. As a result of those meetings, Google began to de-index websites named in FDA warning letters, and social media platforms like Facebook and Instagram redirected users looking to buy opioids to a government run help line.

Lessons Learned from 20 Years of Chronic Pain

By Mia Maysack, PNN Columnist

This year, I'm honoring the 20th anniversary of how long my head has been hurting.

I was fortunate to learn at a young age that we're not invincible. Slipping into a coma, two brain surgeries, and years of rehab resulting from a near death experience with bacterial meningitis has a way of humbling a person.  

Healing isn't linear and has thus far proved to be a lifelong process for me. I've got no reason to believe I've reached an apex of wellness.   

Simply put, the journey has had many ups and downs. Relationships with others were shattered because my own life was in pieces. I didn't know how to effectively communicate with others about my health, because I wasn't fully aware about my own limits. This ultimately overtook my career goals and almost claimed my sanity.

Maybe I lost my mind long ago. If you see it, let me know!

Of course, it hurts to bid adieu to people I still care about, but I've had to evolve to put my own self-care first. Drama isn't a thing I'm physically well enough to take on, as it greatly depletes me. I've had to cultivate avoidance of it by all means necessary.  

I've grown to no longer feel a desire to excuse or justify the accommodations I need. And I know that anyone who doesn't honor what my personal needs are couldn't be what's best for me. So though distance can hurt, it isn't always a loss. 

Anything that's forced -- be it with another person or within our own selves – is a signal to me. An instant message from somewhere deep. It’s an inner wisdom we all carry, always there to be heard and listened to. 

We may not know what exactly is happening in regards to our pain or illness, nor comprehend why it exists, where it came from or what we can do about it. But when we slow down to the point of fully acknowledging ourselves lovingly, there's power, freedom and a sense of peace in that.  

Of course, it's not just about us. How we conduct ourselves has an impact on every one and thing around us. If nothing else, this pandemic has undeniably demonstrated that much. Nothing about life, especially living under strenuous circumstances, is easy. It requires us to keep our heads up and continue growing.  

This requires many things -- diet, sleep, exercise and lifestyle balance, to name a few. One of the more recent revolutions of mine has been that I do not need to follow suit on what anybody else -- providers included -- thinks is best for me. It's a team effort and any form of support is vital and definitely a blessing. But any person or thing outside of ourselves can only take us so far. Our loved ones, friends and our healthcare teams need open communication about that.  

Not everyone has a cure or fix, but our circumstances can improve with a more helpful attitude. We can tune in and reflect on what aligns with where we're at on the path of figuring all this out – and then proceed according to that. We're still just as valuable as we've always been, just in different ways. 

A Greater Purpose

Until I chose to no longer allow this to just happen to me but affirmed myself in active boss mode over what repeatedly tests my will to live, there's a co-existence that's possible -- an intimacy with yourself, a language spoken within, that's solely between you and your vessel. 

It's not glamorous. It’s isolating and lonely. But the truth is that we're not alone, and your reading of this column thus far is a demonstration of that.

What I needed in life didn't exist, so I dedicated myself to creating ways to keep the parts of myself alive that matter most. I'm devoted to never giving up because there's a greater purpose to be found in our challenges. 

There are always new breakthroughs. We cannot know if something could help if we don't keep our minds and hearts open to it by coming to terms with our losses. Without a doubt, that’s the hardest thing I've ever done in my life, other than survive every day.

Addressing tough moments doesn't mean that's the end of them. But letting these conditions dictate the overall quality of my days became intolerable and unacceptable. Pain is a part of us – but not who we are. I’ve evolved to accept the past for what it was, the present as it is, and the future for whatever it'll be.  

Partake in self-pity moments when you must, but don't unpack and live there. It is okay, normal and natural to breakdown or even completely fall apart. Start over. Life is always evolving and it requires the same from us.

Mia Maysack lives with chronic migraine, cluster headache 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.

How Poppy Seed Muffins Could Get You Flagged by a Drug Test

By Pat Anson, PNN Editor

If you’re a patient who is prescribed opioid pain medication, you may have been warned not to eat poppy seed muffins or bagels before a drug test.

The tiny black seeds may contain trace amounts of morphine and codeine, which can be detected in a drug screen and wreak havoc with your medical care. A positive test could result in your doctor taking you off opioid medication or even dropping you as a patient.

Is the poppy seed warning accurate or just an urban myth? A group of researchers wanted to find out, so they ran a series of tests to measure opiate levels in commercially available poppy seeds. They washed, steamed and heated the seeds to see how that changed concentrations of three opium alkaloids: morphine, codeine and thebaine.

Washing or soaking the poppy seeds in water significantly reduced the presence of all three opium alkaloids. So did heating the seeds at a temperature of 392 F for at least 40 minutes.

However, baking the seeds in a muffin for 16 minutes at 392 F didn't significantly change the opium alkaloids, possibly because the internal and external temperatures of the muffins reached only 211 F and 277 F, respectively.

“Baking had no significant effect on concentrations of opium alkaloids. Overall, these results indicate that opium alkaloids may not be significantly affected by baking or steam application and that poppy seeds may require water washing or extended thermal treatment to promote reduction of these compounds,” said lead author Benjamin Redan, PhD, a research chemist who works in the FDA’s Institute for Food Safety and Health.

Redan says poppy seed muffins would have to be baked for at least two hours just to reduce morphine and codeine levels by 50 percent – which is not a recipe for passing a drug test or for baking tasty muffins.

The findings were recently published in the American Chemical Society’s Journal of Agricultural and Food Chemistry.

Poppy Seed Tea

Researchers and law enforcement agencies have been paying more attention to the lowly poppy seed because of anecdotal reports of people using the seeds to brew a potent tea that can be used for pain relief or to get high.

Late last year, Drug Enforcement Administration classified unwashed poppy seeds as a Schedule II controlled substance. While the poppy plant has long been classified as an illegal substance, the unwashed seeds were exempt because they were not perceived as a problem until recently.

“Individuals wishing to extract the opium alkaloid content from unwashed poppy seeds, use the seeds to create a tea, which contains sufficient amounts of alkaloids to produce psychoactive effects,” the DEA said. “Unwashed poppy seeds are a danger to the user and their abuse may result in unpredictable outcomes including death.”

The Internet is filled with stories about people experimenting with poppy seed tea. One alternative health website even has a recipe for making poppy seed tea that comes with a stark warning.

“Unfortunately, the abuse of or having insufficient knowledge about this tea has led to a few fatal incidences,” the recipe warns.

Tiny Implant Could Revolutionize Stimulators

Pat Anson, PNN Editor

Engineers at Rice University have created a tiny implant – about the size of a grain of rice -- that can electrically stimulate the brain and central nervous system without using a battery or wired power supply.

The magnetically powered implant generates the same kind of high-frequency signals as much larger battery-powered stimulators used to treat chronic pain, epilepsy, Parkinson's disease and other medical conditions. It could be implanted almost anywhere in the body in a minimally invasive procedure.

Researchers demonstrated the viability of the implants by placing them beneath the skin of laboratory rodents that were fully awake and free to roam about their enclosures. The rodents preferred to be in portions of the enclosures where a magnetic field activated the stimulator, which provided a small voltage to the reward center of their brains.

"Doing that proof-of-principle demonstration is really important, because it's a huge technological leap to go from a benchtop demonstration to something that might be actually useful for treating people," said Jacob Robinson, PhD, a member of the Rice Neuroengineering Initiative and corresponding author of a study published in the journal Neuron.

"Our results suggest that using magnetoelectric materials for wireless power delivery is more than a novel idea. These materials are excellent candidates for clinical-grade, wireless bioelectronics."

The implant has a thin film of magnetoelectric material that converts magnetic energy into electricity. Lead author Amanda Singer created the film by joining together two layers of very different materials.

The first layer, a magnetostrictive foil of iron, boron, silicon and carbon, vibrates at a molecular level when it's placed in a magnetic field. The second layer, a piezoelectric crystal, converts mechanical stress directly into an electric voltage.

This method avoids the drawbacks of radio waves, ultrasound, light and other wireless methods to power stimulators, which can interfere with living tissue or produce harmful amounts of heat.

RICE UNIVERSITY

"The magnetic field generates stress in the magnetostrictive material," Singer explained. "It doesn't make the material get visibly bigger and smaller, but it generates acoustic waves and some of those are at a resonant frequency that creates a particular mode we use called an acoustic resonant mode."

Acoustic resonance in magnetostrictive materials is what causes large electrical transformers to audibly hum.

"A major piece of engineering that Amanda solved was creating the circuitry to modulate that activity at a lower frequency that the cells would respond to," Robinson said. "It's similar to the way AM radio works. You have these very high-frequency waves, but they're modulated at a low frequency that you can hear."

Tiny implants capable of modulating the brain and central nervous system could have wide-ranging implications. They could replace battery-powered implants used to treat epilepsy and reduce tremors in patients with Parkinson's disease. Neural stimulation could also be useful for treating depression, obsessive-compulsive disorders and chronic intractable pain.

Singer said creating a signal that could stimulate neurons without harming them was a challenge, as was miniaturization.

"When we first submitted this paper, we didn't have the miniature implanted version," she said. "When we got the reviews back after that first submission, the comments were like, 'OK, you say you can make it small. So, make it small.’

"So, we spent another a year or so making it small and showing that it really works. That was probably the biggest hurdle. Making small devices that worked was difficult, at first."

In all, the study took more than five years to complete, largely because Singer had to make virtually everything from scratch.

I’m a POW in the Opioid Crisis

By Douglas Hughes, Guest Columnist

If you can hear the muffled sound of champagne being uncorked by lawmakers viewing my image, it’s no mistake. They have ignored my cries for help for a number of years, along with those of millions of other intractable pain sufferers.

I am 69 years old and have lost over forty pounds since August 2018. I am 6’2” and weigh 139 pounds, less than I did in eighth grade.

I cannot get anyone to care for me medically. I eat all the time, something else is wrong.  I had to change my primary care provider just to get a simple eye exam, the kind you do in a hallway. When tested, I could only see the top "E" with one eye. I had rapid-advancing cataracts.  

My picture is reality!  We have been so stigmatized and basic medical treatment denied to us, while the opioid pain therapies which kept us alive were abruptly taken away to profit from our deaths. 

Does my image impart distress? If not, you may hold the fortitude and inhumanity required for public office today. In West Virginia, elected officials still believe the opioid crisis is a due to a single drug -- prescription opioids -- diverted from a single source: pain clinics.

DOUGLAS HUGHES

We have done nothing morally or legally wrong to deserve the horrendous lack of basic civility that you would show a wretched animal. I frequently relate my desire to be treated as a dog. Not in humor, but for the compassion that a dog would get if it was suffering like I am. 

The federal government has gone to extraordinary measures to brutalize the functionally disabled for personal enrichment and fiduciary windfall for programs like Medicare, Veterans Affairs, Workers Compensation, Medicaid, private retirements plans and others.

The largest windfall is to health insurance companies, which reap immense savings by curtailing the lingering lives of their most costly beneficiaries, the elderly and disabled. 

You May Be Next

Since the Vietnam War, there have been many advances in emergency medicine. More people are saved each year, yet left in constant pain. In the blink of an eye, you could become one. A car wreck, botched surgery or numerous health conditions can leave you with chronic or intractable pain.  

My image is a warning. I didn’t become the person you see until the government intervened in the pain treatment I was getting for 25 years. This was under the guise of a well-orchestrated effort by many state and federal agencies. 

The Drug Enforcement Administration has been the most prolific in this coordinated, decades-long effort.  In 2005, I witnessed them investigate and close a pain clinic where I was a patient.

My doctor was at the top of his field, a diagnostic virtuoso of complicated pain conditions.  He himself suffered from one pain condition of which I was aware.  No drug seeker could ever pass themselves off as a legitimate pain sufferer in his practice, yet he was harassed and forced to close because of assumptions of opioid overprescribing asserted by medically untrained law enforcement.      

It was my great fortune to have him diagnose the crushing injury in my torso and hips after twelve years of suffering.  He and two other pain specialists said I was “one of the most miserable cases” they had ever seen.

The loss of this and other outstanding professionals has repercussions even today. New doctors being trained are misled to believe the doctor-patient relationship is nonexistent. It was sacrificed to special interest greed and the conflagration of a drug crisis that will never end until that relationship is restored.

How easily has the public been misled to believe all physicians became irresponsible at the same time by treating pain conditions incorrectly with opioids? Now we have law enforcement dictating what pain treatment is appropriate. It is nonsensical at best and unimaginably inhumane at its heart.

My picture is the culmination of this government-standardized pain treatment and its consequences.  If heed is not taken immediately by the medical profession, lawmakers and society at large, you may be next to choose between suicide or emaciation.

Killing functionally disabled intractable pain sufferers like me, or non-responsive elderly in hospitals, will not stop opioid addiction, drug diversion or overdose deaths. It will however leave you a skeleton, praying for help like a prisoner of war.

Only the hearts of tyrants and fools see anything redeeming in that.

Douglas Hughes is a disabled coal miner and retired environmental permit writer in West Virginia. He recently ended his candidacy for governor due to health issues.

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