Doctor Accused of Overprescribing Opioids Fights to Keep Her License

By Pat Anson, PNN Editor

A northern California doctor who is beloved by many of her patients could lose her medical license because of allegations by the state medical board that she overprescribed opioid medication and other drugs. Dr. Corrine (Connie) Basch runs a solo primary care practice in Arcata, a small city in rural Humboldt county.

“They were looking to put a head on a spike so they could claim they were doing something about the opioid crisis,” Basch told PNN. “I am not considered a negligent doctor in town, nor am I a pill mill. And it would have taken them all of ten minutes to figure that out if they had asked anyone in my community if there was a problem here.”

A formal complaint against Basch by the Medical Board of California, first reported by the Lost Coast Outpost, centers on her treatment of five pain patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication. Although Basch had tapered them to lower doses, the complaint alleges the amounts are still excessive and the combination of drugs places the patients at risk of overdose and death.

Board Executive Director Kimberly Kirchmeyer is seeking the revocation or suspension of Basch’s license for excessive prescribing, gross negligence and failure to maintain adequate medical records.

At no point in the 25-page complaint is it alleged that any of Basch’s patients have overdosed or been harmed while under her care.  The board began its investigation of Basch in early 2018 but didn’t file the accusation until last month – suggesting it didn’t think there was any imminent threat to her patients.

“They went after me for no good reason, conducted an ‘investigation’ that was so obviously flawed, published a defamatory accusation on the Internet prior to giving me a chance to defend myself or even correct the factual errors, revealed private details of my patients’ cases on the Internet when those people live in a small town where people already know each other’s business, and would force a small town doc who treats poor people  to come up with several years’ income to defend herself and her license,” Basch said.   

DR. CONNIE BASCH

All five of the patients in the medical board complaint were already on high doses of opioids and benzodiazepines before Basch started treating them. She tapered these “legacy” patients to lower doses, but some remained on opioid doses as high as 664 MME (morphine milligram equivalent) – well above the CDC guideline’s recommended ceiling of 90 MME.   

The CDC and FDA recently acknowledged that patients should not be forcibly tapered to lower doses and that doctors should “work with patients” before tapering or discontinuing opioids. Basch was already using that approach in her own practice. She says patients who’ve become tolerant to opioids should be weaned slowly and it could take 6-12 months just to get them off benzodiazepines.

“I’ve helped a lot of people get off pain meds,” she said. “Some of my patients stay on meds. I have a patient who is super functional on 145 MME. She’s comfortable, she can sleep through the night, and she works. I don’t see a need to lower her, except that she’s afraid. They’re all feeling insecure. They want to get off (pain meds) because there will be literally no one left to prescribe.”

Afraid to Prescribe

In recent years, California’s medical board has aggressively gone after doctors who prescribe opioids at high doses. The state’s controversial “Death Certificate Project” has resulted in threats of disciplinary action against hundreds of physicians, often years after they wrote an opioid prescription for a patient who fatally overdosed. Some doctors received warning letters even though the cause of death was suicide or involved multiple drugs – both legal and illegal.

These and other enforcement actions have had a chilling effect on doctors statewide.

“What we’re finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps,” Dr. Robert Wailes, a pain specialist and chair of the California Medical Association’s Board of Trustees, told Kaiser Health News.

Should Basch lose her license or stop practicing, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

“There are now two docs I know of in our area who have retired early because of similar accusations, and another older doc who lives in a small coastal community south of us who is going through a similar thing right now,” said Basch. “There’s nowhere even to get primary care up here. And if you call and say you want to be a new patient and chronic pain is anywhere on your problem list, you are denied. So these people are literally going to be left with no one.” 

‘Medical Board Malpractice’

Basch has received over 300 letters of support from patients and several from colleagues in the medical community. Her attorney plans to present them as evidence to the medical board.

“Dr. Corrine Basch is my beloved primary care physician,” one patient wrote. “Taking away her right to assess her individual patients for risk vs benefit, forcing a bureaucratic, possibly ill-conceived set of ‘guidelines’ is what I consider Medical Board Malpractice.

“FEAR caused by actions such as yours are keeping legitimately suffering human beings from having a quality of life they deserve. THIS IS SHAMEFUL.”

“I have had my share of doctors over the years but I never had a doctor like Connie. She has ultimately saved my life and I am not just saying that,” wrote another patient who credits Basch for his sobriety after years of addiction to pills and alcohol.

“You don’t punish someone for doing the right thing and helping people get off of drugs. That is not how you fix the opiate problem plaguing America you do it by employing more people like Dr. Connie who knows the right way to get a person clean.”

Basch, who is 55, continues to practice and is gathering evidence to support her case. A hearing date has not been set on the medical board’s complaint.

“They went after the wrong person this time,” she says. “Shaming and humiliating doctors who have lived lives of service, and placing them in a position where they have to give up their calling because the cost of defense is too great late in their careers, is shameful.”   

Why Stem Cell Critics Are Wrong

By A. Rahman Ford, PNN Columnist

In a recent and rather lengthy New York Times article entitled “Stem Cell Treatments Flourish With Little Evidence That They Work,” authors Denise Grady and Reed Ableson do their absolute best to convince their readers that stem cell therapy (SCT) is based on strange, magical hocus-pocus, and its practitioners are all mad scientists. 

They portray stem cell clinics as shadowy castle dungeons lit only by the occasional lightning strike, and filled with glass beakers that froth with fluorescent-colored liquids.  The authors even use the phrase “unproven cell cocktails.”  That little piece of anti-SCT propaganda even scares me a little, and I’ve had SCT.

In the article, the authors trot out the same tired, empty and underhanded tropes that all articles of its ilk like to employ:

• “no clear evidence that these treatments work”

• “gotten way ahead of the science”

• “no regulatory oversight”

• “rogue clinics”

• “scant data”

• “not covered by insurance”

• “high risk”  

• “lack of solid medical evidence”

• “snake oil”

A recent New Yorker article isn’t much different.  Both articles do contain some valid points, but those points are obscured by the scare tactics, fear-charged language and cherry-picked patient cases.

These SCT hit pieces appear from time-to-time, but rarely in publications with the broad readership of the New York Times and the New Yorker.  After reading so many of them over the years, I began to wonder – if stem cell clinics are flourishing, then isn’t that a tacit admission that the fear-mongering isn’t working? 

And if the fear-mongering isn’t working, why do they keep publishing these less-than-objective articles?  

Maybe it’s because they feel like they are part of some consumer protection vanguard to protect Americans from sleazy medical charlatans.  Or maybe it’s because the scare tactics have failed and they have no idea what else to do. 

The fact is, as I wrote in a recent PNN column, the SCT tipping point appears to have been reached. The American public simply isn’t buying what the critics are selling. As many as 1,000 stem cell clinics are now operating in the United States, according to The Washington Post, which predicts the industry is “likely to flourish” despite a judge’s ruling that upheld the FDA’s authority to regulate — and stifle — the industry.    

The Basquiat Effect

But it gets even worse for the anti-SCT purveyors. They may be suffering from what I refer to as the Basquiat Effect.  Jean-Michel Basquiat was a graffiti-inspired painter, sculptor and musician who rose to prominence in the 1980s in New York City. 

Basquiat’s work is laden with social and political commentary, with primordial figures, abstract arrangements and linguistic devices.  One of his more popular motifs was to write words and cross them out. 

Why did he do this?  As quoted from the documentary Jean-Michel Basquiat: Radiant Child, “I cross out words so you will see them more.  The fact that they are obscured makes you want to read them.”

One of Basquiat’s paintings recently sold for $110.5 million.  He was clearly on to something.

Put simply, the Basquiat Effect holds that the more one tries to hide something, the more the people they are trying to hide it from pay attention to it.  This effect becomes even more powerful after the phenomenon that is attempting to be hidden reaches it tipping point. 

Because the American public’s curiosity is already piqued, any mention of the phenomenon, regardless of context, compels the reader to look into it. The principle seems counter intuitive, but SCT critics may have provided a perfect example.  The New York Times and New Yorker articles may actually drive more people toward SCT rather than away. 

One of Basquiat’s trademark graffiti tags was “SAMO,” short for “Same Old.”  It essentially illustrated his disenchantment with the prevailing cultural orthodoxy and his intention to introduce something new, radical and revolutionary as a solution. 

In the same way, SCT is a radical response to the failures of medical orthodoxy. The “SAMO” pills and surgeries that exemplify the “treatment” approach to healthcare have given way to an expanding desire by the American people for procedures that actually “cure” chronic conditions and don’t just mask their symptoms.

The best approach for the anti-SCT purveyors may be to join a pro-cure movement that is clearly succeeding despite their efforts.  Or, they can continue to publish their criticism.  Either way, stem cell therapy will flourish.

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

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

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

Should Postpartum Pain Control Be a Crap Shoot?

By Lynn Webster, MD, PNN Columnist

Anticipating the birth of my second grandchild should have been a purely joyous time. My daughter was about to become a mother for the second time. The miracle of life would unfold again in our family, as it does for thousands of families, every day, all around the world.

My daughter was scheduled to have a repeat cesarean section (I am sharing this story with her permission). The first operation was uneventful, apart from the fact that it produced my first, adorable grandchild.

However, this time I was concerned that my daughter’s post-op pain might not be adequately treated. Since her first C-section three years ago, the hospital system where she delivers has made a public commitment to reducing the amount of opioids prescribed for acute pain by 40 percent.

I worried that the hospital’s choice to lessen the amount of drugs prescribed, rather than focusing on patients' clinical needs, might mean my daughter's need for pain control would be unmet.

The idea of my daughter enduring inadequately treated pain haunted me, as it would any father, but as a pain specialist, it may have troubled me even more. I have seen the unspeakable suffering that insufficiently managed pain can cause. I also know that inadequately treated acute pain can lead to chronic pain.

The thought that my daughter might be the victim of the hospital’s well-intended attempt to reduce opioid use was highly unsettling to me, but there was little I could do about it. Doctor or not, I could not be sure that my daughter would receive the individualized treatment she deserved after her surgery.

So, several weeks before her scheduled operation, I advised my daughter to talk to her surgeon. Specifically, I asked her to find out how her post-op pain would be treated.

The irony of the situation was not lost on me. This was the first time in my career as a pain specialist and anesthesiologist that I had to worry a family member might suffer from ineffectually managed post-op pain. It was humbling. I felt as impotent and powerless as any other bystander.

I know the hospital system is addressing the number of people who abuse drugs, and their response may well be appropriate in some cases. But my daughter isn’t contributing to the problem. Why should she have to pay the price for the inappropriate behaviors of others?

Pain control was no longer only a professional concern for me. It was now very personal.

My fear was reinforced by a June 3 The Wall Street Journal article by Sumathi Reddy, “The Push for Fewer Opioids for New Mothers.” In it, Reddy describes the national effort to reduce the amount of opioids used postpartum. 

Of course, opioids should not be used if there are safer and more effective alternatives. But some hospitals are taking aggressive steps to eliminate the use of any opioids. As a result, the individual needs of a patient may be lost in an effort to tackle a public health problem.

Something seems out of kilter with that line of thinking. It reminds me of the adage of not seeing the forest for the trees.

The American College of Obstetricians and Gynecologists (ACOG) recently published new guidelines for treating postpartum pain. The guideline does not exclude the use of opioids from post-op pain control. In fact, the recommendation for opioid use seems to be logical and consistent with patient-centered care.

Fortunately, my daughter’s OB is an excellent and caring clinician. Her approach is patient-centered, and she provided my daughter -- cautiously -- with the necessary analgesics to help her manage her recovery. My daughter did not like the way the medication made her feel, but without it she would not have been able to care for her newborn. 

An ACOG recommendation specifically states that postpartum pain management should involve shared decision-making. My daughter needed to understand the risks and benefits of opioids before deciding whether or not to accept them to treat her pain. This approach worked for her. The mother of my new, healthy, precious grandchild deserved no less.

All mothers across the world deserve the same level of care. I fear, in some cases, they may not be as lucky as my daughter. They may not receive the care they need, and the joy of giving birth may be superseded by the agony of unmanaged acute pain.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. Lynn is a former president of the American Academy of Pain Medicine, author of the award-winning book “The Painful Truth” and co-producer of the documentary “It Hurts Until You Die.” He lives in Salt Lake City with his wife and now two granddaughters.

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.

16 Key Findings about Arachnoiditis

By Forest Tennant, MD, PNN Columnist

We initiated the “Arachnoiditis Research Project” about 6 months ago. Our first goal was to pull together what we have learned to this point. While we continue to gather new information, this short report is an interim attempt to get our findings into the patient and practitioner communities.  

This report is not intended to be a formal protocol or guideline, but a way to pass on what we have found and determined during the course of our learnings.  Please keep in mind that research is neither static nor absolute.  In the future, newer findings will likely both clarify and expand upon our initial findings as presented in this report.    

Frankly, the response to the Arachnoiditis Research Project has been overwhelming. Each day we receive inquiries from patients and practitioners. Patients want help. Practitioners want to know what to do.

We have now reviewed over 300 MRI’s of Adhesive Arachnoiditis (AA) cases. We have received inquiries from 5 continents and over 17 countries. One thing is clear. The need to research and identify treatment for AA is here.  

The goal of our research is to bring AA treatment to every community worldwide. How? By developing both diagnostic and treatment protocols that can be implemented by any medical practitioner in every community. Here is what we have learned so far:

16 Findings about Adhesive Arachnoiditis  

1. Treatment efficacy is best achieved by the simultaneous administration of a three component medication program to suppress neuroinflammation, promote neuro-regeneration (nerve regrowth), and provide pain control to function. Medication for these three categories can be competently prescribed by any primary medical practitioner.  

2. The most common cause of lumbar sacral AA is no longer dural puncture or trauma but intervertebral disc deterioration and spinal stenosis, which has forced cauda equina nerve roots to rub together causing friction, inflammation and adhesion formation.  

3. Although there is no single symptom that uniquely identifies AA, there are a few symptoms that the majority of AA patients will usually have.  A simple 7-question screening questionnaire has been developed to help in identifying potential AA. If a patient answers “yes” to at least four of the seven questions in the test, they should immediately be evaluated by a physician to confirm the diagnosis.  

4. A contrast MRI or high-resolution TESLA-3 or higher MRI can be used to visualize the cauda equina nerve roots and show abnormal swelling, displacement, clumping, and adhesions between clumps and the arachnoid layer of the spinal canal covering.  A greater number and larger size of clumps is generally associated with the most severe pain and neurologic impairments.  

5. Some MRI’s are inconclusive or equivocal even though typical symptoms may be present.  In these cases, therapeutic trials of anti-neuroinflammatory drugs and pain control are warranted.  

6. Spinal fluid flow impairment is common in AA patients and appears to be a cause of headache, blurred vision, nausea, and dizziness.  Obstruction or back-up of fluid can often be seen on an MRI.   

7. Spinal fluid “seepage” throughout the damaged arachnoid layer and wall of the lumbar sacral spine covering is common and can be a cause of pain, tissue destruction and severe contraction that causes restriction of extension of arms and legs.  A physical sign of chronic seepage is indentation of tissues around the lumbar spine.  

8. Pain due to AA appears to be a combination of two types: inflammatory and neuropathic (nerve damage).  It may also be centralized with what is called “descending” pain.  Proper pain control may require medicinal agents for all types.  

9. There is currently no reliable laboratory test for the presence of active neuroinflammation, although certain markers (by-products of inflammation) such as C-Reactive Protein and myeloperoxidase may sometimes show in the blood.  Neuroinflammation may go into remission, but it may also act silently to cause progressive nerve root destruction.  

10. Basic science and animal studies show the neuro-steroids (hormones made inside the spinal cord) have the basic functions of neuroinflammation suppression and neuro-regeneration stimulation.  Our observations clearly indicate that the patients who have improved the most have taken one or more of the hormones reported to reduce neuroinflammation and promote and support neuro-regeneration.  

11. Patients who have had AA for longer than 5 years must rely on aggressive pain control to function and achieve recovery.  After a long period of untreated neuroinflammation, scarring of nerve roots is too severe for much regeneration to occur.  

12. The drugs and hormones required for suppression of neuroinflammation and promotion of neuro-regeneration do not need to be taken daily to be effective and prevent side effects.  Medical practitioners have a choice of agents, and they can be competently prescribed by primary care practitioners.  We have found that three times a week dosing is usually quite sufficient.

13. Persons who have developed AA without warning, trauma or chronic disc disease have often been found to have a genetic connective tissue disorder of which the most common are Ehlers-Danlos syndromes.  

14. Cervical neck arachnoiditis is primarily a clinical and presumed diagnosis as there are no nerve roots to clump and observe on MRI.  The key MRI finding is spinal fluid flow obstruction and the major clinical symptom is extreme pain on neck flexing.  

15. Only ketorolac among the anti-inflammatories, and methylprednisolone among the corticoids are routinely effective in AA.  Other anti-inflammatories and corticoids either do not cross the blood brain barrier or therapeutically attach to glial cell receptors.  

16. Some seemingly unrelated compounds found to suppress microglial inflammation in animal and invitro studies also appear to have therapeutic benefit as neuroinflammatory suppressors in AA patients.  These include pentoxifylline, acetazolamide, minocycline and metformin.

The Tennant Foundation has also released an enhanced protocol for primary care physicians who treat AA patients. You can find the protocols and research reports on our website.

Forest Tennant, MD, MPH, DrPH, has retired from clinical practice but continues his groundbreaking research on the treatment of intractable pain and arachnoiditis.

This report is provided as a public service by the Arachnoiditis Research and Education Project of the Tennant Foundation and is republished with permission. Correspondence should be sent to veractinc@msn.com

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.

Kratom Saved My Life

By Kim DeMott, Guest Columnist

I was diagnosed with lupus in 2013 after spending several years with unexplained chronic pain, debilitating fatigue and other awful symptoms. Lupus was the first of many chronic conditions that I would be diagnosed with in coming years, including fibromyalgia, Sjogren’s syndrome, osteoarthritis, osteoporosis, carpal tunnel syndrome, migraines, endometriosis, interstitial cystitis, chronic fatigue, chronic pain, anxiety and depression.

To treat these conditions, I was prescribed 28 different medications a day, including massive amounts of powerful opiates like oxycodone, hydrocodone and morphine, along with high doses of benzodiazepines such as Ativan, Xanax and Klonopin.

Even though I was taking all these medications, I was still in pain, had bad anxiety and no quality of life. I was housebound and practically bedridden (or at least couch-ridden) most days.  I had to use a cane, walker and even the walls in my house to walk on the really bad days, which is no way for a young woman and mother of two to live.

My health became so bad that in the fall of 2014 my doctors labeled me permanently disabled and told me to get in-home support services and file for SSI. I was only 29 years old.

I would have to tell my kids that mommy was in too much pain and too tired to take them to the park, play with them, pick them up, take them to school or be involved in any of their activities. This caused me and them to miss out on precious time and memories we can’t ever get back.

I couldn’t cook, clean, drive, go to the store or even go for a quick walk. They would see and hear me hiding in the bathroom or bedroom crying from the pain and the feeling of failure I felt as their mom.

I couldn’t take a shower, brush my teeth and get dressed in the same hour because I would have to rest after every task I did. Getting dressed consisted of putting on clean pajamas, because that’s the only thing that wouldn’t hurt to wear. I became isolated and depressed. I stopped answering my phone, texts, messages and emails.

KIM DEMOTT

The medications that the doctors put me on made me gain a ton of weight and made me feel incredibly dizzy, sleepy, forgetful, sick to my stomach and like I was in a fog. These side effects led to even more medications being prescribed, which meant more pills to add to the already huge amount I took daily. I was so depressed and hopeless that I actually attempted suicide a few times.

For over two years now I have enjoyed drinking my kratom tea a couple of times a day. It helps promote my mood and energy like a cup of coffee would. The tea also relieves my aching joints and muscles, making my chronic fatigue and pain much more bearable.  

I am in no way cured and my pain is not completely gone, it never is and never will be. But the discomfort is down to a level that I can deal with, live with and function at. I still have bad days, but they are nowhere near as frequent or as bad as they used to be.  

Kratom has greatly improved my quality of life and dramatically changed it for the better. I’m not spending every day on the couch or in bed anymore and my kids have their mom back. We are doing so much more together.

Not only are my kids happy, but so are my fiancé, family and friends. Everyone tells me they have seen a huge change in me and that I am much more like the old me, which is something I have longed for since everything started. For the first time in years I don't feel like a prisoner in my own body and like my chronic illnesses and pain control me.

I am healthier, happier, take better care of myself and eat better. I’ve also been able to lose weight since I can cook and exercise again because I have better mobility. I even feel confident that I will be able return to work again someday soon and plan on returning to school this year.  

I look forward to each day and excited for what the future will bring. Most importantly, I am setting a better example for my kids. All thanks to this plant. Kratom has truly not only saved my life but also given me renewed hope. Without this plant I do not believe I would still be alive today.  

Kim DeMott lives in California with her two children.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

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

WHO Recognizes Chronic Pain as Disease With New Coding System

By Pat Anson, PNN Editor

The World Health Organization has adopted a new classification system for chronic pain, assigning it the code ICD-11 in a revision of the International Classification of Diseases (ICD). It’s the first time the ICD will include a specific diagnostic code for chronic pain, along with sub-codes for several common chronic pain conditions. 

The new classification system is important because it treats chronic pain as a distinct health condition and as a symptom to an underlying disease. It also takes into account the intensity of pain, pain-related disability, and psychosocial factors that contribute to pain.

“The inclusion of the new classification system for chronic pain in ICD-11 is an important milestone for the pain field,” says Lars Arendt-Nielsen, MD, President of the International Association for the Study of Pain (IASP), which headed a task force that developed ICD-11.

The new coding system will make it easier for physicians to diagnose, classify and get treatment for chronic pain patients. Insurers will use the new codes to authorize payments and researchers can use them to more easily track and measure the effectiveness of therapies. That’s the good news. 

The bad news is that the ICD changes won’t formally take effect until January 1, 2022. 

Under the current system, chronic pain conditions are poorly categorized under the code ICD-10, which makes it difficult for complex conditions such as fibromyalgia and Complex Regional Pain Syndrome (CRPS) to be classified. That led some physicians to diagnose patients with unexplained pain as having a somatic symptom disorder. 

“A diagnosis of somatic symptom disorder implies that the pain is caused by a behavioral, that is, mental condition. However, it is not appropriate to diagnose individuals with a mental disorder solely because an alternative medical cause cannot be established,” Jaochim Scholtz, MD, an IASP task force member, explained in Practical Pain Management.  

Under the new coding system, patients with fibromyalgia or CRPS could be classified as having a “primary pain” disorder, one of seven new sub-codes for chronic pain conditions:

1. Chronic primary pain

2. Chronic cancer-related pain

3. Chronic post-surgical or post-traumatic pain

4. Chronic neuropathic pain

5. Chronic secondary headache or orofacial pain

6. Chronic secondary visceral pain

7. Chronic secondary musculoskeletal pain.

There is some overlap between the different diagnostic codes. For example, neuropathic pain can be a symptom of cancer or chemotherapy, while trigeminal neuralgia could fall under neuropathic or orofacial pain. The idea is to give physicians a range of codes to choose from instead of the limited choices they have today.

“The integration of chronic pain in ICD-11 sends a strong signal that pain will achieve appropriate representation in this international standard for reporting diseases and health conditions,” said Scholtz. “The coding system also provides fundamental information for the identification of health trends and healthcare planning. It is widely hoped that the new systematic classification of chronic pain in the ICD-11 will support epidemiological, and other research that is essential for the development of future health policies.”

The classification system was outlined in a free online article published in the January 2019 issue of PAIN.

Crackdown on Opioids and Benzodiazepines Ignores Their Benefits

By Roger Chriss, PNN Columnist

The overdose crisis is driving a lot of panicky policy to more closely regulate the prescribing of scheduled drugs, from oxycodone and other opioids to clonazepam and other benzodiazepines, which are used to treat anxiety.

A California doctor was recently accused of unprofessional conduct and could lose her license for prescribing “excessive amounts of opioid medications and benzodiazepines.” And a New Jersey doctor faces criminal charges for prescribing the so-called “Holy Trinity” of opioids, benzodiazepines and muscle relaxers.

The crackdown on opioids and benzodiazepines may help reduce overdose fatalities, but it also risks depriving people of beneficial drugs. Research is finding new benefits for familiar drugs that may slow diseases and improve quality of life.

In a recent Phase III clinical trial, a “novel” combination drug was shown to ease Charcot-Marie-Tooth disease. The drug – called PXT3003 -- provided “meaningful improvement” for people with a hereditary neuropathy that results in a progressive loss of sensation and motor function.

This is a significant advance for people with Charcot-Marie-Tooth disease, which currently has no treatment. The FDA recently gave PXT3003 its “fast track” designation, which speeds the development of drugs for which there is an unmet medical need.

PXT3003 is a combination of three familiar drugs, naltrexone (an opioid receptor blocker), baclofen (a muscle relaxant), and sorbitol (an alcohol sugar). The how and why of this combination of drugs is not well-understood at present. The manufacturer Pharnext says there are “multiple main mechanisms of action” that improve nerve, muscle and immune cells.

In other words, research on existing drugs with known risk profiles has led to a novel treatment. Ordinarily, the use of an opioid and a muscle relaxant is regarded as clinically inadvisable and is actively counseled against in many prescribing guidelines.

Benzodiazepine Research

A similar outcome is occurring with long-term benzodiazepine therapy in congestive heart failure (CHF). An editorial in Psychotherapy and Psychosomatics reported that low-to-moderate doses of benzodiazepines “seem to be helpful in silent myocardial ischemia, angina, essential hypertension, and CHF, especially in patients with comorbid anxiety.”

This builds on research from Taiwan in 2014 showing that anti-anxiety medications are “associated with a decreased risk of cardiac mortality and heart failure hospitalization in patients after a new myocardial infarction.”

Long-term benzodiazepine therapy is already seen as important in the treatment of rapid eye movement sleep behavior disorder, a condition in which causes people to act out vivid and violent dreams, often injuring themselves or bed partners. Low-dose clonazepam therapy for months or even years turns out to be a highly effective treatment.

In the same fashion, benzodiazepines are used to treat stiff-person syndrome, a rare neurological disorder that causes extreme muscle rigidly and spasms that can make walking impossible. According to the National Institutes of Health, therapy to treat stiff-person syndrome includes “anti-anxiety drugs, muscle relaxants, anti-convulsants, and pain relievers.”

‘Political Interference’ in Medicine

But treatments for these disorders and the development of new regimens for other disorders may be impeded under current federal and state laws and guidelines. Recently a coalition of six physician groups called on state legislatures to end their “political interference” in the practice of medicine and the patient-physician relationship.

“The insertion of politics between patients and their physicians undermines the foundation of trust this relationship is built on and inhibits the delivery of safe, timely, and comprehensive care. Outside interference endangers our patients’ health by limiting, and sometimes altogether eliminating, access to medically accurate information and to the full range of health care,” the coaltion warned.

“Physicians should never face imprisonment or other penalties for providing necessary care. These laws force physicians to decide between their patients and facing criminal proceedings.”

— Coalition of physician groups

“Physicians should never face imprisonment or other penalties for providing necessary care. These laws force physicians to decide between their patients and facing criminal proceedings. Physicians must be able to practice medicine that is informed by their years of medical education, training, experience, and the available evidence, freely and without threat of criminal punishment.”

The statement was released by the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Congress of Obstetricians and Gynecologists, American Osteopathic Association and American Psychiatric Association.

As the past couple of years have shown, prescribing guidelines have a way of leading to blanket prohibitions. And a risk of blanket prohibitions is that we may miss important benefits.

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.

Beautifully Catastrophic

By Mia Maysack, PNN Columnist

Whatever I do, there is going to be detrimental repercussions to my health and I do it anyway. Because if I didn't, I may as well be dead. At least in the sense of the quality of life I'd be lacking.

I have a love for creative expression through dance. As a young girl swimming and diving were my passions, but after a freak accident in the water gave me bacterial meningitis and chronic migraine, I found another passion in the form of dancing.

Over the years, my ability to dance had lessened and getting a nerve disorder diagnosis was another wake-up call. But who's to know what the future holds. It’s wise to make good use of this gift while still able.

I am lucky to get a few solid moments of dancing and when I get to the point of breaking a sweat, heightened pain is just about guaranteed as a result.

What's a person to do, if they can’t do what they love? For me, the answer has been to pursue it at a lighter extent, a handful of times per month as opposed to every day as it was in the past.   

My movement has evolved into a demonstration of my ailments --- to acknowledge and release them, while providing outside space for them to breathe. We all have unique traits and possess individualized talents that I believe were given to us as gifts to provide back to the world. 

I submitted this creative dance video to the 4th Annual Migraine Moment Short Film contest. It’s dedicated to those mourning the loss of who they were or wanted to be before becoming a Pain Warrior.

Prior to the making of this video, there was a solid month of resilience training. After recording it, I crawled into bed and rocked myself in response to the excruciating pain induced by dancing.  

The pain was horrendous and lasted for days, but I felt gratitude to have had even just a few moments to do something that brings me joy. I worked hard for that extra Spoon to be able to continue on through discomfort. It’s empowering to reclaim a part of myself in the midst of what can feel like broken pieces.   

A lot of us have had to give up things we've enjoyed. That’s another realm of grief that ordinarily doesn't make it to the surface, because we're fixated on just getting by one moment at a time. That alone takes much of our energy. 

It's imperative that we not allow our ailments or conditions to become our identity. I no longer look at it as if I “make myself sick” by engaging in this release. I already am sick. And that's not my fault either.   

I've found when I take conscious time to engage in meaningful activities that aren't revolved around being sick that there’s an impactful sense of replenishment. 

Some of us have been dealing with our battles for longer than we even want to think about or have situations that are expected to be incurable or life-long. What if we shifted our focus on what we can do right now? 

A lot of odds may be stacked up against us but we need not underestimate the power within an adequate self-care approach and routine. Although we've fallen down 7 times, we must rise up 8 -- and as many more times it takes.

It's important to mourn our losses so we may then find the strength to move on from them. It provides the opportunity to re-invent ourselves, which in my experience has been necessary more times than I'm able to count.  

I've referred to my chronic conditions as a thief. These illnesses have taken away jobs, social engagements and the concept of commitment. It's devastating to pick up the broken pieces of a shattered life, especially when it happens repeatedly.  

Alas, the good news is that our mindset is entirely within our power. What can be done with this pain, how will it be productively used?

There will always be those that’ll suggest I shouldn’t ever wear headphones, blast loud music or engage in any sudden movements. But I’ll never give it up!!

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

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

Judge Rules FDA Can Regulate Stem Cells

By Pat Anson, PNN Editor

A federal judge has ruled that the U.S. Food and Drug Administration does have the legal authority to regulate stem cells made from adipose tissue – a patient’s own fat cells.

The decision is a blow to U.S. Stem Cells, a Florida-based company that produces and markets stem cells derived from body to treat rheumatoid arthritis, lupus and other chronic illnesses. At least three of its patients were blinded after having the stem cells injected into their eyes while being treated for macular degeneration.

The FDA has been struggling in recent years to rein in the fast-growing stem cell industry, which often markets procedures that the agency considers unproven and potentially dangerous.

“Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients,” acting FDA Commissioner Ned Sharpless, MD, said in a statement.

“The FDA has advanced a comprehensive policy framework to promote the development and approval of regenerative medicine products. But at the same time, the FDA will continue to take action — such as issuing warning letters or initiating court cases — against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use.”

The FDA sent a letter to U.S. Stem Cell nearly two years ago warning the company that its laboratory safety standards were inadequate and could lead to contamination.  A year later, the agency sought a permanent injunction against the company, which led to Monday’s court decision by U.S. District Judge Ursula Ungaro.  

“The clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. This decision today is a victory for the FDA’s work to stop these bad actors and to protect patients,” said Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research.

U.S. Stem Cell and its chief science officer Kristin Comella have yet to respond to the judge’s ruling. In the past, they have argued the FDA doesn’t have the legal authority to regulate cells derived from a patient’s own body tissue.

The Los Angeles Times has reported that Comella’s purported PhD in “stem cell biology” was issued by an unaccredited online university in Panama. Three-year doctorate degrees can be purchased at Panama College of Cell Science for less than $9,000. The college has been vigorous in defense of its most famous graduate.

“Through Dr. Comella’s leadership, she and her team have trained and certified more than 700 physicians worldwide in adult stem cell therapy,” the college said recently in a blog post.

KRISTIN COMELLA

“So it is understandable that against this backdrop, America’s most gifted adult stem cell clinician, Kristin Comella, should be singled out for attack, criticism, and personal smearing in an effort to chill and silence her activities, if not outright ban them. A federal lawsuit was even filed against her to stop her treatment of patients and to slow the progress of adult stem cell therapy.”

In addition to the lawsuit against U.S. Stem Cell, the FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center and Cell Surgical Network Corporation from producing cellular products for stem cell clinics without FDA approval.

The agency has also issued warning letters to a number of clinics, including one recently sent to R3 Stem Cell of Scottsdale, Arizona warning that its treatments for Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS) are not FDA approved.  

Prescription Opioids Play Minor Role in Massachusetts Overdoses

By Pat Anson, PNN Editor

Two new studies in Massachusetts – one of the states hardest hit by the overdose crisis – highlight the role of multiple substances in most overdose deaths and how limiting the supply of prescription opioids has failed to reduce the number of drug deaths.

Researchers at Boston Medical Center's Grayken Center for Addiction analyzed toxicology reports on nearly 2,250 fatal overdoses involving opioids in Massachusetts between 2014 and 2015. Overdose data in Massachusetts is considered more reliable because it is one of the few states to extensively use toxicology testing.

Only 9 percent of the deaths in Massachusetts involved prescription opioids alone. Most of the overdoses (72%) involved illicit fentanyl or heroin, while one in five (19%) involved a combination of heroin, fentanyl or prescription opioids.

Other substances such as alcohol, marijuana, stimulants (cocaine and methamphetamine) and non-opioid medications (benzodiazepines and gabapentin) were also frequently involved.

“Using multiple substances, in addition to opioids, is the rule rather than the exception for opioid-related deaths,” researchers reported in the journal Drug and Alcohol Dependence.

“Our study draws attention to the heterogeneity of the problem at hand and that there is not a one-size-fits-all approach to addressing the overdose epidemic, which is increasingly driven by polysubstance use.”

Over half of the Massachusetts overdoses involved someone with a diagnosed mental illness. Homelessness and a recent incarceration also raised the risk of a fatal overdose involving both opioids and stimulants.

"As a provider, these findings indicate a pressing need to address and treat not just opioid use disorder, but other substances that patients are misusing," said lead author Joshua Barocas, MD, an infectious disease physician at BMC. "To truly make a difference in reducing opioid overdose deaths, we must tackle issues such as homelessness and access to mental health services. This means not only investing in treatment but also implementing tailored programs that address the specific barriers to accessing care."

Opioid Prescriptions Down 39% since 2015

The number of opioid prescriptions has declined significantly in Massachusetts over the last four years, according to a recent report from the state’s Department of Public Health. In the first quarter of 2019 there were over 518,000 prescriptions filled for Schedule II opioids such as hydrocodone and oxycodone – a 39% decline from the first quarter of 2015.

But the decrease in prescriptions has failed to make much of a dent in Massachusetts’ opioid overdose rate, which peaked in 2016 with 2,100 deaths and remains stubbornly high.  

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

In 2018, nearly nine out of ten opioid-related deaths (89%) in the state involved illicit fentanyl, with cocaine (39%), heroin (32%), and benzodiazepines (40%) such as Xanax also commonly found.

Only about ten percent of the overdose deaths in the fourth quarter of 2018 involved prescriptions opioids, virtually unchanged from the 2014-2015 study.

A Pain Poem: What I Wouldn't Do

“What I Wouldn’t Do”

By Serina Mikunda

What would I do just to feel okay?
To feel less pain, for only a day?
I would hope and wish and pray
But what would I not do?

We would do most anything to quell desperation
To feel like more than an aberration
To achieve more than adaptation
But our laser tight focus can lead us askew

Would you take meds from a loved one's drawer?
Cause suffering to someone you say you adore?
Turn into someone you would abhor?
Changing from the person you once knew?

Would you use heroin you got off the street?
Would you lie, or would you cheat?
Dig in deeper to a life of deceit?
Justifying that relief was long overdue?

I know you are feeling a lot of abandonment
Not getting much help from the medical establishment
I offer only my view, no judgement
I know you are doing the best you can do

I know what is asked of you is crazy
I know people think that you're just lazy
And your ability to see beauty is getting hazy
These urges are getting hard to subdue

Think long-term, join us in the fight
Help us shoot sparks until something ignites
We will all warm ourselves by the firelight
Warming others by the light of our virtue

Because we have all walked through the fire
And we know all too well the situation is dire
But you have the chance to lead, to inspire
Whether it happens is all up to you

Serina Mikunda is an author and activist in St. Louis, Missouri. Serina lives with Ehlers-Danlos syndrome.

Pain News Network invites other readers to share their stories (and poems). Send them to:  editor@PainNewsNetwork.org. 

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

Federal Task Force Releases ‘Roadmap’ to Treat Pain Crisis

By Pat Anson, PNN Editor

A federal advisory panel has released its final report on recommended best practices for acute and chronic pain management, calling for a balanced approach to pain treatment that focuses on individualized patient care – not rigid guidelines that triggered a pain crisis for millions of Americans.

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

Unlike previous federal efforts that focused primarily on limiting access to opioid medication while expanding access to addiction treatment, the 116-page report by the Pain Management Best Practices Inter-Agency Task Force took a more comprehensive approach to pain management that focused on the needs of patients, improving their quality of life, and establishing a “therapeutic alliance” between patient and clinician.   

The panel sought and received feedback from over 5,000 patients, advocates and healthcare providers on issues such as suicide, patient abandonment and the stigma associated with chronic pain. Several patient stories were incorporated into the final report.

Even longtime critics of federal pain care policies were impressed.

“This report from the HHS Pain Management Task Force is exceptional, in my view. Rarely have I seen a report that is of such high quality, with such reasonable, common-sense recommendations,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. “The willingness to recognize concerns expressed by people with pain and by healthcare providers is not something we have often seen, and it is refreshing to see those comments play an important role here.”

“I truly hope this is a huge step forward,” said Andrea Anderson, a pain sufferer and patient advocate. “I think there was much to be praised, such as the focus on individualized patient care, the need for multi-disciplinary treatment teams with care-coordination, a more robust focus on post-surgical pain management, an emphasis on moving complementary and integrative health approaches into the main stream of pain treatment, and the need for further education and research  on a number of important topics.”

No Repeal of CDC Guideline

The task force did not call for a repeal of the CDC’s controversial opioid prescribing guideline, but said the guideline should be clarified and updated with better evidence to supports its recommendations..

“The Task Force recognizes the utility of the 2016 CDC Guideline for many aspects of pain management and its value in mitigating adverse outcomes of opioid exposure. Unfortunately, misinterpretation, in addition to gaps in the guideline, has led to unintended adverse consequences. Our report documented widespread misinterpretation of the CDC Guideline — specifically, the recommendation regarding the 90 morphine milligram equivalents (MME) dose,” the report found.

“Educating stakeholders about the intent and optimal application of this guideline and re-emphasis of its core beneficial aspects are essential. Instances have been reported where the CDC Guideline was misapplied to the palliative care and cancer populations with pain and to providers who care for these patient populations.”

The task force called for a more “even-handed approach” to opioid prescriptions that allows doctors to use their own clinical judgement on how to treat patients.

“Various health insurance plans, retail pharmacies, and local and state governments are implementing the CDC Guideline as policy, limiting the number of days a patient can receive prescription opioids even when the seriousness of the injury or surgery may require opioids for adequate pain management for a longer period. A more even-handed approach would balance addressing opioid overuse with the need to protect the patient-provider relationship by preserving access to medically necessary drug regimens and reducing the potential for unintended consequences,” the task force said.

That kind of thinking is heresy to anti-opioid crusaders and politicians who consider the CDC guideline a cornerstone of the government’s war on drugs. Even before the task force report was finalized, 39 state and territory attorney generals wrote a letter of protest.   

“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment that causes nearly 50,000 deaths annually,” the letter warns. “It is incomprehensible that officials would consider moving away from key components of the CDC Guideline.”

Critics have also claimed that some task force members have a conflict-of-interest because of their financial ties to pharmaceutical companies. Oregon Sen. Ron Wyden (D) — who has received millions of dollars in campaign donations from healthcare companies and insurers — recently told Mother Jones that the task force was “being used as part of the industry’s broader effort to water down the CDC’s recommendations on opioid prescribing.”

The 29 members who served on the task force included representatives from the FDA, CDC, VA and Office of National Drug Control Policy; as well as academic and medical experts in pain management, addiction treatment, pharmacy, oncology, psychiatry and interventional medicine. There was only one patient advocate, Cindy Steinberg of the U.S. Pain Foundation.

Interestingly, Harold Tu, MD, the lone dentist on the panel, is the father-in-law of Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played a key role in drafting the CDC guideline. Tu voted in favor of the task force’s final report.

The report’s recommendations are voluntary and not binding on the Department of Health and Human Services or anyone else. The task force was created in 2016 by the Comprehensive Addiction and Recovery Act to “determine whether there are gaps in or inconsistencies between best practices for pain management.”

Those gaps have been identified. Whether anyone will get to work and fill them is unclear.

“I think the task force provided a very good analysis of the problem with recommendations that if implemented should help millions of Americans with pain and reduce the problem with opioids,” says Lynn Webster, MD, past president of the American Academy of Pain Medicine and a PNN columnist.

“My concern is that there doesn't appear to be any teeth to the recommendations. I would like to have seen some specifics but that may have been too much to expect at this stage.”

Emmy Winning Video Perpetuates Myths About Addiction

By Dr. Lynn Webster, PNN Columnist

"Rebekkah's Story" recently won an Emmy for Short Format Daytime Program at the 46th Annual Daytime Emmy Awards. The six-and-a-half minute video was produced by Truth Initiative, a non-profit created to campaign against tobacco use that recently launched an opioid misuse and education campaign called The Truth About Opioids.

Rebekkah is a young woman addicted to opioid medication and heroin who spent five days in a “treatment box” publicly detoxing on a New York City street.  The documentary has also been broadcast on television and can be seen online:  

Though billed as educational, the producers of “Rebekkah’s Story” failed to accurately convey the facts. This is not the first time we've seen movies about drug use and addiction that misinform.  

I wrote a blog not long ago about the problems with two mainstream movies -- "Ben Is Black" and "Beautiful Boy"— both of which reinforced unhelpful narratives about addiction. In both films, good people from good families found themselves caught in the web of addiction, seemingly with no personal responsibility for it. 

"Rebekkah's Story" continues in the same tradition. It exploits Rebekkah and her experience while perpetuating three myths about addiction that do us no favors as our nation struggles with this terrible illness.

At the same time, millions of Americans with chronic pain are being forced off opioid medication — left to suffer in part because of these three myths:

Myth #1: Heroin Use Starts With Prescription Drugs

The movie begins with a misleading statistic: “Eighty percent of heroin users started with a prescription painkiller.” That implies taking painkillers as prescribed for medical use leads to using heroin 80% of the time, and that is not accurate. 

The 80% statistic comes from a 2013 study of heroin users who reported nonmedical use of opioid pain relievers before initiating heroin. Most of them had not been prescribed those opioids for pain; they obtained the drugs from family or friends for nonmedical use.  

In fact, the vast majority of people who use heroin have abused other substances prior to abusing prescription opioids. Usually, their long history of substance abuse begins in adolescence with tobacco, alcohol and other substances besides opioids. Moreover, by 2015, one in three heroin users initiated their opioid use with heroin.

Rebekkah's situation -- progressing from oxycodone to heroin -- was unusual. The video presents her story as a cautionary tale of what can happen if you use prescription opioids, but her story is atypical. Almost always, there are other factors that contribute to the transition from appropriate use to abuse and addiction. This is a truth not addressed in the film. 

The film begs the question: Why did Rebekkah start to use heroin? What did heroin provide that she could not resist? 

Myth #2: Withdrawal Is Synonymous to Addiction

"She had been an accomplished dancer and athlete, and that was lost when her addiction took over her life and self-image," explains the video's website. "Now Rebekkah is regaining control of both — courageously making her detox public in order to help other people while she works towards a new start."

The producers of “Rebekkah’s Story” present a poignant story, but they propose that withdrawal is synonymous with addiction. That is incorrect.

Withdrawal may be associated with addiction, but it does not necessarily follow from addiction. Not everyone who goes through withdrawal has the disease of addiction, and not everyone with addiction must go through the agonizing withdrawal that Rebekkah did.

A major problem that most people with addiction face is the stigma associated with their disease and their inability or unwillingness to obtain help. Fear of facing a legal penalty (such as incarceration) or a social consequence (estrangement from family members, job loss, etc.) often prevent those who use heroin from seeking treatment.  

People experience opioid withdrawal largely because the healthcare and criminal justice systems make access to appropriate and safe treatment illegal, unavailable or unaffordable.  

Myth #3: Detoxification Ends Addiction 

The ending of "Rebekkah's Story" differs from reality, too. Addiction is usually a life-long disease and patients who recover frequently relapse. The video's tidy and triumphant resolution does not accurately reflect what occurs in real life.  

It's troubling how the producers went about creating the video in ways that subtly strengthen and exploit the three myths about addiction.

Their set was a makeshift hospital room projected in a cubicle visible to pedestrians walking near Times Square. The setting was essentially a stage for performance art at Rebekkah's expense.

Rebekkah takes on the role of a gladiator engaging in combat against a metaphorical beast: the agony of opioid addiction.

She is the heroine with whom we should empathize. We are supposed to share her anger toward the wicked doctors who prescribed her pain medication. 

People watch as Rebekkah suffers from withdrawal without receiving the medical treatment that should be available to anyone in withdrawal. It was surprising that, in the documentary, an addiction physician was complicit in exploiting a person undergoing withdrawal.   

No one should be forced to experience what Rebekkah went through. She should have been given appropriate medical care as she recovered from heroin abuse. 

"Rebekkah's Story" claims to tell the truth about opioids. It does not. All it shows is Rebekkah’s decision to voluntarily and publicly experience a horrible withdrawal that was both unnecessary and avoidable.

Unfortunately, compliant and non-addicted pain patients who are currently being forced off opioid medication don’t have the same stage to tell their stories. Their voices often go unheard, and their agonies are invisible.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and 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.

A Pained Life: Who Benefits From the Opioid Crisis?

By Carol Levy, PNN Columnist

For the first time in almost 40 years, I have to fight to get my codeine prescription filled.

I understand intellectually what so many pain patients have said about the frustration, upset and upheaval they experience when a pharmacist refuses to fill their prescription or insurance refuses to pay for it. Or harder still, what they go through having their opioid medications cut down or stopped completely.

But I did not understand the emotional side of it until it happened to me.

The insurance company refused to pay for my codeine prescription. They had no problem filling it for the last many, many years but suddenly they need "authorization" from the doctor. How does that make sense? Writing the prescription was authorizing. Why do they need to add a second permission?

It is now over three weeks. The pharmacist tells me they have contacted the doctor's office three times: "You need to call them and find out why they haven't responded."

When I call the office, they tell me the pharmacy never sent over the forms they need.

So I call the pharmacy back. They recite a fax number for the doctor’s office. It is not the right number. I give them the number the doctor's office just gave me. “We'll try it again right now,” she says.

I keep my fingers crossed and hope I don't run out of pills before it is resolved — if it is resolved.

The pharmacy clerk and I talked the day the prescription was refused by the insurance company. I was venting my frustration over not being able to get the prescription filled, especially because it is the same prescription I have had for years, one that was always covered by my insurance.

To my surprise she says: "It is not just narcotics. Many insurance companies are refusing to cover or making unwarranted demands, requiring many more hoops to jump through. They have refused to cover certain creams and hormones, other prescriptions, non-narcotics that are routinely given and, until now, paid for by the insurance companies."

This is appalling. And makes no sense.  

But then I start thinking about it and was struck by a thought: Yes, there is an opioid crisis. And we’ve all heard the reasons they blamed patients for the “crisis.”  But I think there may be another factor at play: the profit margin.

After all, if we pay insurance premiums but they refuse to pay for our medication -- forcing some folks to pay cash rather than wait for all the rigamarole to be completed -- then the insurance company comes out way ahead. They get our monthly fees and work to make sure we get as little as possible in return. 

I hope I am merely being paranoid. But somehow, I doubt it.

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.

FDA Clears New Wearable Device for Migraine

By Pat Anson, PNN Editor

A neuromodulation device worn on the arm and controlled by a smartphone has been cleared by the Food and Drug Administration for the treatment of acute migraine. The Nerivo Migra device was developed by Theranica, an Israeli medical technology company, and is expected to be available in the U.S. later this year.

The FDA’s market authorization is based on the results of a double-blind, placebo-controlled study of Nerivo Migra involving 252 migraine patients at 12 headache clinics in the U.S. and Israel. The study findings were recently published in Headache: The Journal of Head and Face Pain.

Over two-thirds of patients who wore the device for 30-45 minutes during a migraine attack experienced pain relief two hours after treatment, compared to only about a third of those who wore a sham device. For many, the pain relief was sustained 48 hours after treatment.

THERANICA IMAGE

"The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks, both at two and 48 hours after treatment," said lead investigator Dr. Brian Grosberg, MD, director of the Hartford Healthcare Headache Center in Connecticut.

Placed on the upper arm, Nerivio Migra uses smartphone-controlled electrical pulses to disrupt pain signals. At this time, the device is only indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine. But company officials say it shows potential as a treatment for other pain conditions.

"We have identified at least 7 different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development," said Alon Ironi, CEO and co-founder of Theranica. "While the company is preparing to launch the Nerivio Migra in the United States market later this year at an affordable price, we remain committed to continuing our clinical development, expanding the use of remote electrical neuromodulation therapy for additional indications.”

Theranica has not disclosed what its “affordable price” will be. Over the next four months, the company said it would begin a series of clinical studies of Nerivo Migra at 30 headache clinics in the U.S. to assess patient selection and correct product use.

A handheld neuromodulation device – called gammaCore –  is currently available for about $600 to treat migraine and cluster headache.  Another device used to treat migraine – called Cefaly – is worn on the head and costs about $350. A new class of injectable migraine drugs is even more expensive, costing about $7,000 a year or $580 for each monthly dose.

"Over the last 20 years my colleagues and I have used triptans and ergots for acute migraine treatment. There is a large unmet need for new treatments in this population when these medications are not effective, are contra-indicated, or have non-tolerable side effects,” said Stephen Silberstein, MD, a member of Theranica’s medical advisory board.

“In addition, triptans and most current acute migraine medications, including over-the-counter drugs indicated for migraine, are associated with medication-overuse headache, which is associated with increased frequency of migraine attacks, and often results in chronic migraine.”

Migraine affects a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can cause vomiting, blurriness or visual disturbances, as well as sensitivity to light and sound. Women are three times more likely to suffer from migraine than men.