Mayo Clinic Research Shows Stem Cells May Treat Paralysis

By A. Rahman Ford, PNN Columnist

In a case report recently published in Mayo Clinic Proceedings, a 53-year-old California man paralyzed from the neck down in a surfing accident experienced dramatic improvement after an injection of his own stem cells.  

Chris Barr can walk again and has shown other improvements in his motor and sensory functions. His case is significant, because currently there is no FDA-approved therapy that can reverse the devastating life-changing effects of paralysis from spinal cord injuries.

Barr’s inspiring story can be seen in this video produced by the Mayo Clinic:

Barr was one of 10 paralyzed adults enrolled in a Phase I clinical trial that looked at the safety, side effects and ideal dose of stem cells. Early findings show that patient response varied. Mayo researchers call Barr a “superresponder” because his treatment was so successful.

"In this case report, the first patient was a superresponder, but there are other patients in the trial who are moderate responders and nonresponders," says first author Mohamad Bydon, MD, a Mayo Clinic neurologic surgeon. "One of our objectives in this study and future studies is to better delineate who will be a responder and why patients respond differently to stem cell injections.”

According to the National Spinal Cord Injury Statistical Center, about 288,000 Americans currently suffer from a spinal cord injury (SCI). Over 17,000 Americans suffer SCI’s each year, costing the health care system over $40 billion annually.  The estimated lifetime cost for each patient can range from the hundreds of thousands into the millions of dollars, and their life expectancy rates fall far below those without SCI.

Chronic pain is a serious problem that can result from SCI, affecting about two-thirds of patients, with one out of three reporting their pain as severe. With the inherent limitations of medical interventions such as surgery, medication and physical rehabilitation, new strategies are needed to improve functional outcomes and quality of life.

Although stem cells have  successfully been used to treat inflammatory conditions that affect the spinal cord, such as arachnoiditis, published reports on their safety and effectiveness in treating SCI‘s are scant.

Animal studies have demonstrated effectiveness in treating SCI with embryonic stem cells and human neural stem cells. Mesenchymal stem cells (MSC’s) derived from bone marrow have also been successfully used to treat SCI in rats, as have human umbilical cord-derived stem cells. And adipose stem cells derived from fat have been used to improve functional recovery in dogs with SCI.

Barr’s Impressive Results

After being paralyzed in the surfing accident, Chris Barr’s condition initially improved after a posterior cervical decompression and fusion. However, that improvement plateaued after six months. Barr had complete loss of motor function below the site of his injury, including bowel and bladder sensation.

Barr enrolled in the Mayo study nine months after his injury. His stem cells were collected by taking a small amount of fat from his abdomen. Over eight weeks, the cells were grown in the laboratory to 100 million cells. Those MSC cells were then injected into Barr’s lower back, 11 months after his injury.

The results from the therapy were impressive and long lasting. Eighteen months after stem cell injection, Barr’s total upper extremity motor score increased from 35 to 44. There was also considerable improvement in his total lower extremity motor scores, from 36 to 49. Improvement in sensory scores was likewise remarkable.

Barr reported significant improvement in his quality of life, as well as mental and physical health. He was able to walk further, faster and for a longer period of time. His range of motion for shoulder flexion and shoulder abduction also improved.

“Given the multidimensional complexity of SCI, cell-based therapies have offered substantial promise as a therapeutic strategy because of the multifactorial roles that stem cells can potentially provide,” Bydon wrote.

Bydon and his colleagues caution in generalizing from Barr’s remarkable results, although there is cause for optimism. The Mayo team plans to continue analyzing patient responses, and further results will be published on the other nine trial participants.

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

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

This column is not intended as medical advice and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CDC Planning to Update Opioid Guideline in 2021

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention is in the initial stages of updating or expanding its controversial opioid prescribing guideline, which has been widely blamed for patient suffering, abandonment and suicide since its release in 2016.

CDC officials outlined their plans today at a meeting in Atlanta of the Board of Scientific Counselors (BSC) for the agency’s National Center for Injury Prevention and Control (NCIPC).

The update – which could take two years to complete – is likely to include recommendations for treating short-term acute pain, as well as how to taper patients safely off opioid medication.

Public pressure has been building on the CDC to clarify the guideline. Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioid prescribing have been widely adopted as policy by federal agencies, states, insurers, pharmacies and many doctors.

“Some policies and practices citing the guideline went beyond its recommendations,” said Dr. Deborah Dowell, Chief Medical Officer for NCIPC and co-author of the guideline. “The guideline does not support abrupt tapering or sudden discontinuation of opioids, but has been inappropriately cited to justify hard limits or cutting off opioids.

“In addition, we’ve heard reports of misapplications beyond the guideline’s clearly stated scope. For example, applying the recommendations to patients in cancer treatment or experiencing surgical pain.”

Last year the American Medical Association took a stand against the “misapplication” and “inappropriate use” of the guideline. The Food and Drug Administration has also warned that many patients are being tapered off opioids inappropriately, putting them at risk of withdrawal, uncontrolled pain and suicide.

Although the matter appears urgent, Dowell said the CDC was “just getting started” on updating the guideline. She said updated recommendations would likely not be finalized until late 2021, five and a half years after the initial guideline was released.   

‘Way Too Long to Wait’

During a public comment period, critics called the guideline a failed public health experiment that has done more harm than good.

“No one should have to die in pain. No one should have to live in pain,” said Amber Bullington, an intractable pain patient who was forcibly tapered off opioids. “We need to rescind the CDC guidelines and undo the harm you’ve done. You say you want to save lives. You’re not saving lives. Overdoses continue to escalate. Pain patients are dying and suffering.”   

“I have talked to patients all over the U.S. who are being denied treatment because of the reign of terror that has been established against doctors who try to treat them with opioid prescriptions. This has to stop. This is madness,” said patient advocate Richard “Red” Lawhern.

Others expressed concern about the guideline not being updated until 2021.

“It’s important that something be done in the interim to negate the effect of the misuse of the guideline across the board by so many government agencies,” said Richard, a pain patient and advocate. “Two years is way too long to wait for this to get fixed.”

“Chronic pain patients may not be able to last that long. Many won’t,” said Peter Pischke, a patient advocate. “I beg you guys, keep this in mind. You will have to make it clear and un-vague so that every politician, bureaucrat, administrator, every law enforcement official knows that what you guys tried to do in 2016 failed miserably when it came to patients with cancer and patients with chronic pain.”

The BSC voted unanimously to form a new “Opioid Workgroup” of 12 to 20 people to direct efforts to update the guideline. While a wide range of medical specialties would be represented on the panel, there was no mention of including patients or patient advocacy groups in anything more than an advisory or ad hoc role.

Nominations to serve on the Opioid Workgroup will be accepted until February 4, 2020.

As PNN has reported, the CDC has funded three new studies of opioid and non-opioid treatments for chronic pain. Draft reports are expected to be finalized in early 2020. Two additional studies of treatments for migraine and acute pain were recently awarded to the Mayo Clinic and Oregon Health & Science University, respectively, at a cost of $1.36 million. Results from those studies are not expected until August 2020.

Why Does Treating Chronic Pain Cost So Much?

By Carol Levy, PNN Columnist

Five weeks ago, I had a deep brain stimulator implanted in a last-ditch effort to relieve my trigeminal neuralgia pain or at least make it more acceptable.

Prior to the surgery, I was required by Medicare to be evaluated by a neuropsychologist. His personal conclusions about me, plus some standardized cognitive testing, would decide if I have the cognitive ability to understand the surgical risks and the procedure itself. He also decides if I am mentally sound enough to tolerate the operation and all that goes with it.

I have not yet received a bill from him, but based on other costs I would expect the 2 to 3 hours I spent with him to cost around $300-$500.

Why is this? Why waste the insurance company's money, my time, the doctor's time, and if I have a copay, my personal money? My neurosurgeon should be aware enough and savvy enough to make such determinations.

I have had other brain implants in 1986, 1987 and 1991. At the time, they were a relatively new procedure and the risks probably worse given their newness.

But my neurosurgeon was fully able to make his own decisions as to my ability to understand and emotionally tolerate the uncertainty and risk.  It was required then, as it is now, that the patient have a trial period of 7 to 10 days between temporarily implanting the device and putting it in permanently. If the patient doesn’t see a benefit, then the implant is determined to have failed and not worth a permanent implantation.

That is all well and good, except for the fact that some patients do not see any benefit or change in the pain for two, three or sometimes up to 6 months.

By having to endure a trial, the patient has to go through 2 surgeries, 2 general anesthesia, and at least 10–14 days in the hospital. The cost to insurance is gigantic. The cost to the patient potentially even higher:

My first implant had no benefit at trial, but my surgeon went ahead with the permanent implantation anyway. After about a month I told him I was having no benefit. We agreed he should remove it. But until I made a date to do so, for some reason, maybe because it never occurred to me to turn it off, I left the implant on.

My trigeminal neuralgia at that point was so bad I had to get my face washed under general anesthesia every few months, as any touch to the affected area of my face was torturous.

One morning, three months after the implant, I stepped into the shower, a drop of water hit my face and there was no pain! I could touch that area of my face and the spontaneous pain and the background constant pain were all gone. Had the implant been removed because of the failed trial, I would never had had the opportunity to have that relief.

How many times have we been told by a doctor to try a treatment, medication or therapy that we have already tried to no avail? How often has insurance required us to try the cheaper drug first, by virtue of "step therapy" also known as "fail first"?

Chronic pain has been estimated to cost the U.S. over $635 billion annually in medical expenses and lost productivity, which is more than the cost for cancer, heart disease and diabetes.

Why is it that chronic pain costs the country so much? Maybe if we got rid of some of these “requirements” and just let doctors and patients do the deciding, the costs would go down.

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.

This column is for informational purposes only and should not be considered as professional medical advice, diagnosis or treatment. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Tell the Truth About the Opioid Crisis

By Kathleen Harrington, Guest Columnist

There are so many untruths being reported about this false opioid crisis. I never read the truth about the REAL problem.

I’ve been a chronic pain patient for over 25 years, living with chronic cervical pain, degenerative disc disease, cervical lordosis, stenosis, lumbar scoliosis and bone spurs. Like so many thousands of others, I had my pain medication and quality of life ripped from me.

None of my questions were answered and I was never given a reason why I was losing my meds. I was ignored as the doctor turned and walked out of the room.

I had great pain control for 25 years. I followed all the rules, passed all the drug screens, never tried to refill my scripts early and never claimed they were “stolen” to get more. Now I am the patient that no one wants. As soon as it is known that I need pain meds, a wall goes up.

The medical profession tossed us all in the garbage. The persecution of people with chronic pain is everywhere in this country. Prescription meds are not the problem and never were.

Now I see there are doctors asking for donations from us in their fight against being prosecuted by the DEA simply because they write a high number of valid opioid prescriptions for their patients.  

Where were they when the CDC Guidelines came out in 2016 and most doctors took them as new laws? They certainly didn’t have our backs then.

KATHLEEN HARRINGTON

And what about the threatening letters the DEA sends to physicians about prescribing controlled substances? ILLEGAL drugs are the drugs killing people! Instead of fighting the real fight, chronic pain patients, the disabled and our vets have been the scapegoats. We have been denied the medications that allowed us to have productive lives, raise our kids, work and take care of our homes, just have a nice life with our pain controlled. Who will tell the truth finally? 

We have followed the rules with our meds and this country is catering to the addicts with compassion because they have an addiction. Are you kidding me? Chronic pain patients don't get high off their meds. We take them to live without pain as much as we can.

The medical profession and the rule makers in this country are despicable. The overdose deaths are not from patients who have been taking these meds the way they have been prescribed for years and decades in some cases. Tell the truth!

Heroin is hitting the streets at an alarming rate and this country is okay with that. Something very wrong here. Very wrong. Could it be that the opioid epidemic that started with local news showing junkies nodding off (or dead) in their cars with little kids in the back seat was blamed on pain patients because we can be found with the click of a mouse?

My God, in Pennsylvania there will soon be a “safe injecting site” where addicts who have purchased their illegal heroin can go and shoot up!  Just in case they overdose on too much or tainted heroin, they can be revived. All the sympathy is for the poor addict who CHOOSES to do a drug that they know is addicting or could kill them in seconds.

We did not choose to have conditions that cause us pain. We just want to enjoy our lives, family and contribute to society. If a chronic pain patient goes to the ER with intractable pain, we are turned away and literally labeled drug seekers and addicts in the system. The addict who goes to the same ER is treated with compassion and offered treatment.

For myself, I am not confident that things will change. The insurance companies and the doctors’ malpractice insurance are now dictating what patients can have and how much. The state licensing agencies are also advising what meds can and cannot be prescribed.  

I found a medication that worked very well on my neck pain and constant muscle spasms, but I am not allowed to have it any longer. The reason is that this medication is, along with many others, abused on the street. That is exactly what I was told. Way too many people are deciding what is best for me, and it is not my doctor. She really has no say in what she can prescribe to me.  

I really don’t have any hope of enjoying this stage of my life with proper pain control. After working all my life, I am looking at years of suffering. This treatment is against our human and civil rights, but no one seems to care. Seems we are nothing but a burden on this country and the healthcare system.  

How many more chronic pain patients who have had their meds yanked from them with no warning or explanation have to commit suicide from uncontrolled pain? 

Kathleen Harrington lives in Michigan.

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

This column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Gabapentin Linked to Growing Number of Suicide Attempts

By Pat Anson, PNN Editor

We’ve reported several times about the abuse and lack of effectiveness of gabapentin, a nerve medication increasingly prescribed to treat fibromyalgia, neuropathy and other types of chronic pain.

It turns out gabapentin is also involved in a growing number of attempted suicides.

In a large new study published in the journal Clinical Toxicology, University of Pittsburgh researchers looked at over 90,000 calls involving medications to U.S. poison control centers. They found that calls about gabapentin and the muscle relaxant baclofen increased significantly just as opioid prescriptions began declining.

“Gabapentin and baclofen are two medications that have seen increased availability to patients as alternatives to opioids for the treatment of acute and chronic pain. With greater accessibility, poison center exposures have demonstrated a marked increase in toxic exposures to these two medications,” wrote lead author Kimberly Reynolds of the University of Pittsburgh.

“As poison center data do not represent the totality of cases in the United States, the steep upward trends in reported exposures reflect a much larger problem than the raw numbers would suggest.”     

Between 2013 and 2017, calls involving the abuse and misuse of gabapentin went up nearly 120 percent, while reports of baclofen being abused or misused rose nearly 32 percent from 2014 to 2017.

Even more concerning is that calls about attempted suicides involving gabapentin rose 80 percent, while calls about attempted suicides with baclofen increased 43 percent. Co-ingestion of sedatives and opioids were common for both medications.

Only 19 deaths involving gabapentin were identified as possible suicides during the five-year study period, but there were thousands of gabapentin-related calls each year coded as attempted suicides — including over 10,000 calls in 2017 alone.

SOURCE: CLINICAL tOXICOLOGY

“It would be anticipated that patients who are prescribed gabapentin and/or baclofen would be more likely to be treated for mood disorders and pain as they are frequently comorbid and therapy overlaps significantly,” researchers said.

“Gabapentin has specifically been recognized for its misuse and diversion potential, synergistic effect with opioid use, and contribution to use disorders. Baclofen misuse has not been as frequently described but is anecdotally observed and associated with severe toxicity, physical dependence, and complicated withdrawal.”

Gabapentin was the 10th-most widely prescribed drug in the U.S. in 2017. Calls to poison control centers about gabapentin were highest in Kentucky and West Virginia, two of the states hardest hit by the opioid crisis. Calls about baclofen were highest in Kentucky, Maine and New Mexico.

The researchers recommend that patients who are prescribed gabapentin or baclofen be prescreened for substance use disorders, mood disorders and suicidal ideation.

FDA Gabapentin Warning

The Food and Drug Administration warned in 2008 that all patients being treated with gabapentin or ten other antiepileptic drugs should be informed about the risks of suicidal thoughts and actions.

The FDA reviewed 199 clinical trials of the drugs and found that patients who received them had almost twice the risk of suicidal behavior or ideation (0.43%) than patients on a placebo (0.24%). That means there would be one additional case of suicidal thinking or behavior for every 530 patients treated with an antiepileptic drug.

“All patients who are currently taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression,” the FDA said.

Gabapentin (Neurontin) and its chemical cousin pregabalin (Lyrica) belong to a class of nerve medication called gabapentinoids. Both drugs were originally developed to treat epileptic seizures, but are now widely prescribed off label to treat a variety of chronic pain conditions.    

A recent Swedish study found that patients taking gabapentinoids had higher rates of overdose, suicide and suicidal behavior than the general population. The risks were strongest in teens and young adults.

A recent clinical review found little evidence that gapapentinoids should be used off-label to treat pain and that prescribing guidelines often exaggerate their effectiveness. The CDC’s controversial 2016 opioid guideline, for example, calls gabapentin and pregabalin “first-line drugs” for neuropathic pain.

In a new draft report being funded by the CDC, researchers say gabapentin showed only “small improvements” in pain for people with diabetic peripheral neuropathy and fibromyalgia. The study by the Agency for Healthcare Research and Quality (AHRQ) is expected to finalized in early 2020.

WWE Superstars Use Stem Cells to Smackdown Pain

By A. Rahman Ford, PNN Columnist

As a child, I was a big fan of professional wrestling. While I don’t follow it as religiously as I used to, I have noticed a rather interesting trend. Several former wrestlers are opting for stem cell therapy to heal painful injuries. And some travel to foreign countries to get stem cell treatments they can’t get in the U.S.

Many people consider professional wrestling a fake sport, but to wrestlers their injuries are very real. Bleacher Report’s Ryan Dilbert has reported on the toll wrestling can take on the body.  He recalled how Diamond Dallas Page was “power bombed” by Kevin Nash, rupturing two vertebrae in his back.  Page was injured so badly he couldn’t finish the match.

"I was in excruciating pain," Page said. "I was on my back, and I crawled to the corner. I didn't go back in the ring."

Three-time World Wrestling Entertainment (WWE) women’s champion Beth Phoenix once finished a match with a broken jaw.

"Fans may see us once or twice a year," said Phoenix, who is now retired. "They don't realize that we go on these grueling tours. We're on the road 300 days a year. There's no recovery time. It's a test of your physical and mental endurance."

A 2014 study in the journal PLOS One found that professional wrestlers had “an alarmingly high premature mortality rate.” Wrestlers were 4.5 times more likely to die than the general population. The authors cited chronic pain and drug addiction as likely culprits.

“It is reasonable to assume chronic musculoskeletal injuries resulting in abuse of pain-relieving prescription drugs play a role in the premature drug-related deaths and possibly suicide among some wrestlers. It is also plausible that the painful injuries are self-treated with high doses of non-steroidal anti-inflammatory drugs (NSAIDs),” they said.

Consider what happened to these three professional wrestlers:

Former Olympic gold medalist Kurt Angle became addicted to painkillers after he fractured his back. At his worst, Angle was taking 65 extra-strength Vicodin a day.

Former WWE Superstar Lance Cade became addicted to hydrocodone after suffering a shoulder injury. He died six months after completing a drug rehab program, with hydrocodone found in his system at the autopsy.

Former WWE Superstar Ashley Massaro committed suicide in May of this year. The 39-year old suffered from migraines and bouts of depression, which she maintained were a result of wrestling injuries.

“WWE used narcotics as a tool to allow me and other wrestlers to perform through our injuries. If we took enough pills the pain went away (temporarily) and we were able to wrestle. Obviously, this worsened our injuries and required us to take more pain medication the next time,” Massaro said in an affidavit for a recently-dismissed federal lawsuit.

‘Substantial Benefit’ From Stem Cells

Some professional wrestlers are turning to stem cell therapy as an alternative to pain relievers. WWE Superstar Ronda Rousey received stem cells to treat an ACL injury to her knee.  In a documentary, Rousey said the damage to her knee was so severe that for several years she could not even comfortably step backwards. Rousey says stem cell therapy “really helped a lot.”

IMPACT Wrestling World Champion Brian Cage recently traveled to Colombia for stem cell treatment for a back injury.

“The injury was awful. One of the most painful moments of my career. I literally thought my career might be over,” Page told the Lords of Pain. “I was doing everything under the sun to try and recover from that, including going to Columbia and getting the stem cells, and I do believe it did have a substantial benefit to it.”

Wrestlers Melissa Santos, Rey Mysterio, Ryback and Angle also made the trip to Colombia for stem cell treatments. Ryback says he is now 100% healed. And Angle recently told fans on Facebook that he’s doing better.

“My shoulders feel great. My neck and back are struggling a bit but I’m optimistic about them getting better just like my shoulders. It usually takes 3-6 months to feel improvement. It’s been 2 months,” Angle said.

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

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

This column is not intended as medical advice and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

My Healing Journey With Chronic Pain

By Mia Maysack, PNN Columnist

The first time people told me that pain begins and ends in our minds, I was just thankful there wasn't a comic book bubble over my head -- demonstrating my thought of punching them in the face.  

But I sat there to humor them, hooked up to a machine that measured my heart and other vital signs. The irony in that moment is that the provider told me to purposefully think of something upsetting to see how I’d respond. 

I could see on the screen that my blood pressure increased. I remained polite while shoving the thought aside as to how draining this office visit was and whether it was a complete waste of time. It’s so disheartening to live like we do in the first place, but then to have an appointment that makes you feel even worse than you did on arrival.

After the Doc realized I was upset, it was brought to my attention that if I'm in need of "that sort" of help I should see another type of doctor. It got even better with the suggestion on my way out the door that I should “be positive and try visualizing an ocean -- that helps!"

That’s when I made the decision to incorporate my medical background with my passion for healing and began venturing into holistic health.

Part of the training to become a “certified life coach”' is to get one for yourself. It felt awkward initially, preparing to connect with a stranger.

But between being fed up with the traditional route and reaching a point of desperation where I'd do just about anything, this connection would serve to be one of the most important contacts of my life.

My career plans had experienced multiple screeching halts over the years, whether I attempted nursing or teaching. I went back and forth quite a bit, trying to find a way to make either of them work in any capacity. But the outcome remained the same because of my physical pain, chronic fatigue and persistent illness.

Even though I am no longer able to run the hospital floor for multiple shifts or teach a classroom of 30 students, I do still possess my course work in medicine and years of work experience, not to mention firsthand experience as a patient with the healthcare system.

It was during the first phone call with my coach that the concept of energy was shaped in a new way. It was explained how our bodies not only feel and respond to experiences, but also essentially tracks them. They get stored in our physical beings and we carry them with us, for better or worse.

I began reflecting on everything I'd planned on telling this person. How I got sick at a young age and almost died. How I went through years of rehabilitation while losing the ability to pursue my passions in life. How I’ve had relentless pain no one could possibly begin to fathom. And that I'm still mourning identities that once made up who I am. 

It struck me that none of that mattered anymore because what I chose from that moment forward is what really counts.  

At a meeting recently, I was asked about my healing journey. I explained that we must first reach our lowest point of being sick and tired of being tired and sick, and then consciously move forward — making the decision to do whatever is necessary for our own sake no matter what.

I showed them what this looked like for me: bawling my eyes out in a fetal position on the cold hard floor, begging the universe for relief, and not knowing how or if I'd be able to go on. 

We're enduring a personal hell on a continuous basis that most regular folk wouldn't be able to handle.  As far as emotions getting the best of me, they don’t anymore because I've grown to be more self-aware through the inner work that I've committed myself to.

It hasn't fixed or cured anything, and it'll continue to be a pursuit for the rest of my days. But I feel safe within my body and mind for probably the first time ever. Security is another thing we can lose as part of the pain experience. 

Nothing is nor will it ever be perfect, but I have come an extraordinary long way. I'm proud of that and believe in these concepts. I've never had more physical discomfort than I do these days but with these tools, I've also never been able to manage so well until now.

We must re-shape our perception of healing and recovery on the other side of fear. And when we're able to make it through the darkness, it then becomes our responsibility to light the way for others. It doesn't make it any easier, but we are stronger together.   

Mia Maysack lives with chronic migraine, cluster disease, fibromyalgia and arthritis. Mia is a patient advocate, the founder of Keepin’ Our Heads Up, an advocacy and support network, and Peace & Love, a wellness practice for the chronically ill and those otherwise lost or hurting.

The information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Consumer DNA Tests Do Not Accurately Predict Disease

By Dr. Lynn Webster, PNN Columnist

Three years ago, I gave my family members DNA kits as Christmas gifts. I thought the genetic health aspects of the test would be an entertaining exercise -- a bit like visiting a psychic who would read tarot cards to predict the future. I didn’t think of it as a serious medical test, and I made sure my family understood that.

These kits have become very popular. More than 26 million people have taken an at-home genetics test, hoping to learn more about their ancestral background, along with their risks of developing certain diseases. But the tests may not live up to either of those expectations.

The U.S. Government Accountability Office (GAO) sent a report to Congress in 2010 alleging that some DNA testing companies used deceptive marketing and other questionable practices. 

The GAO stated that results from DNA tests were “misleading and of little or no practical use.” Their investigation also uncovered the fact that different DNA testing companies provided different results from the same sample. 

Not only were the test results dubious, but the companies made some deceptive claims. One company alleged the results from their testing could help cure diseases. Another claimed the data could predict at which sports a child would excel.

Admittedly, the accuracy of the tests has improved since 2010, but the tests still are, at best, imperfect.

Our genome (the whole of our hereditary information, encoded in our DNA) contains about three billion genes. Of those, only about 20,000 are responsible for disease. But we are more than our genes. Whether or not we will get most diseases depends on a combination of our genes and environment. This interaction of environment and genes is what we call a phenotype.

Of course, there are genetic mutations that are responsible for specific diseases. Single-gene mutations are responsible for about 10,000 diseases, the majority of which are considered rare. Some of the more common single-gene disorders include sickle cell anemia, cystic fibrosis, phenylketonuria, and Huntington's disease.

However, there is no guarantee that direct-to-consumer DNA kits are capable of detecting all common single genetic mutations. Moreover, the absence of a reported mutation from these kits does not mean the mutation does not exist.

Testing may uncover some benign and interesting traits, though. For example, some genetic kits (but not all) can tell you if you have a gene associated with how your earlobes are shaped, whether your urine has an offensive odor after you eat asparagus, or if you are inclined to dislike cilantro.

The accuracy of the health-related portion of the tests is improving. It is now possible to test for genes that predict a person's risk for certain types of breast and prostate cancers. However, placing too much weight on the results of those tests can be dangerous. For example, the tests do not screen for all types of breast cancer, which can lead consumers to falsely conclude their risk of all breast cancers is low if their test results do not indicate a gene mutation associated with breast cancer.

At best, the types of DNA tests that provide information on single-mutation diseases should be accompanied by appropriate genetic counseling. Since most diseases are based on multiple genes and environment, a genetics counselor can help put the test results into perspective.

Deciding how to use the information may be more important than knowing the results of the test. In medicine, we never order a test unless it will help us provide better care for our patient. This may be an important principle to apply here as well.

Privacy Is a Big Concern

We should also be very concerned about how our DNA data will be stored and used. The testing companies' DNA databases can be hacked by people with nefarious motives, or shared with insurance companies or law enforcement. Laws protecting consumers are evolving, but clearly, at-home DNA tests expose consumers to unknown and, perhaps, unintended consequences.

DNA tests were first pitched to consumers as a way in which they could learn about their ancestry. However, the reference data sets were largely European and less accurate in showing lineages in other areas of the world. If your roots were Asian or African, the reports were less likely to accurately reflect where your ancestors lived.

Over time, the data sets have improved and expanded, so consumers with non-European ancestry may get more accurate information about their heritages now than they would have previously. That trend will likely continue.

Whether DNA kits are mostly a gimmick, I cannot say. But it is important to recognize their limitations in providing trustworthy information about our health or ancestry. Certainly, we should not base health decisions on their results, and I would think twice about paying for the privilege of delivering my DNA profile to a for-profit company.

Maybe this year I’ll just give everyone tarot decks.

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

You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences or Pain News Network. 

Kratom vs. Nutmeg: Which Is More Dangerous?

By Pat Anson, PNN Editor

Here’s a trick question for you. Which substance is more dangerous – kratom or nutmeg?

News reports about a recent study that analyzed calls to U.S. poison control centers leave little room for doubt:

“Life-threatening kratom exposures rose by 5000% in 6 years,” is how the Daily Mail reported it.

“Poison Control Centers See Spike in Calls About Kratom Exposure,” was the headline used by WOSU Public Media.

While the headlines are technically accurate, the study published in the journal Clinical Toxicology did not focus solely on kratom. The herbal supplement was one of many naturally occurring psychoactive substances that resulted in over 67,000 calls to U.S. poison control centers from 2000 to 2017.

Marijuana was involved in about half of those calls, followed by plants and mushrooms that act as stimulants or cause hallucinations. Kratom ranked 7th on the list, behind substances like peyote and nutmeg. Yes, nutmeg.

POISON CONTROL CALLS (2000-2017)

1. Marijuana (31,628)

2. Anticholinergic Plants (14,236)

3. Hallucinogenic Mushrooms (10,482)

4. Morning Glory Plants (3,643)

5. Nutmeg (1,962)

6. Peyote (1,717)

7. Kratom (1,631)

8. Kava Kava (1,331)

9. Salvia (622)

10. Absinthe (65)

11. Khat (52)

In most cases, the calls to poison centers involved minor symptoms like upset stomachs or dizziness, but some were serious enough to result in hospitalizations and even deaths. Researchers said marijuana is particularly concerning because it is being sold in candies, cookies and other edibles that a child could get their hands on.

“These substances have been associated with a variety of serious medical outcomes including seizures and coma in adults and children,” said co-author Henry Spiller, director of the Central Ohio Poison Center at Nationwide Children’s Hospital.  “As more states continue to legalize marijuana in various forms, parents and health care providers should treat it like any other medication: locked up, away, and out of sight of children.

Why Did Kratom Calls Spike?

There were only 1,631 calls involving kratom made to poison control centers over an 18-year period. But the numbers started to rise sharply in recent years as more Americans discovered kratom — from 13 kratom calls in 2011 to 682 calls in 2017 — that’s where the 5,000% spike comes from.

The American Kratom Association estimates several million Americans now use kratom to treat chronic pain, addiction, anxiety and other medical conditions.

Side effects from kratom are relatively rare. But researchers say a high percentage of the calls to poison control centers about kratom resulted in hospital admissions and serious medical problems. The chief complaint for many of the calls, according to another study, was that kratom caused agitation, tachycardia (rapid heartbeat), drowsiness, vomiting and confusion.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. Critics say calls to U.S. poison control centers are misleading and a poor choice for research.

“The data drawn from the Poison Control Centers are notoriously unreliable, inasmuch as they are anecdotal reports from the public that are gathered and reported in an unscientific fashion,” said Max Karlin, a spokesman for the Kratom Information & Resource Center. “In the absence of good data, you just end up with a garbage-in, garbage-out situation.”

Kratom has been banned in a handful of states, but is widely available online and in smoke shops. Spiller and his colleagues say it should be regulated in all 50 states.

“The continued rise in kratom usage coupled with the serious medical outcomes identified in our study support the need for federal regulation of kratom along with further research on this public health problem,” they concluded. “While rates of exposure to most natural psychoactive substances decreased during the study period, rates for marijuana, nutmeg, and kratom increased significantly.”

The study offered no explanation for the significant increase in nutmeg calls. Nor did it suggest that nutmeg be regulated.

Nutmeg is a spice known for its pungent fragrance and sweet taste, but in large doses it can also have a psychoactive effect.

As far back as the Middle Ages, people used nutmeg as a medicine and to get high. There is even a page for nutmeg on Reddit, where drug users swap stories and try to figure out the best way to ingest it.

“Do I need to ground them up to a powder or can I just make little pieces and swallow them with water? Can I smoke nutmeg? Can I snort it?” asked a nutmeg newbie.  Most people who tried nutmeg said it made them sleepy, nauseated and wasn’t worth the effort.

While any call to a poison control center is concerning, the number of calls about kratom and nutmeg that came in over an 18-year period pales in comparison to the calls that come in every day about children ingesting hand sanitizers, laundry detergent packets and other toxic products.

Which brings us back to our original question. Is kratom or nutmeg more dangerous?  When used in moderation and with common sense, millions of people will tell you neither one is.

12 Gifts of Knowledge About Chronic Pain

By Pat Anson, PNN Editor

Are you looking for a special gift for a loved one over the holidays? How about a gift to yourself?

Every year we like to feature 12 books that help explain what causes chronic pain, possible ways to treat it, and the impact chronic pain has on society. Our list of books is not comprehensive — no list can be on such a complicated subject — but you or a loved one may learn something you didn’t know before.

These and other books can be found in PNN’s Suggested Reading section. I recently added books on spinal surgery, arachnoiditis, knee pain, illicit fentanyl, low dose naltrexone, meditation, fibromyalgia and CBD.

Click on the book's cover to see price and ordering information. PNN receives a small amount of the proceeds -- at no additional cost to you -- for orders placed through Amazon. As an Amazon Associate, we earn from qualifying purchases.

Taming Chronic Pain by Amy Orr

Scientist and pain sufferer Amy Orr offers practical advice learned from her own journey with chronic pain. “Feeling broken” after years of pain, Orr researched the physical and psychological effects of chronic pain, and shares what she learned in this blunt and sometimes humorous handbook. Orr believes the key to taming chronic pain is to make small changes in your life and become skilled at your body’s response to them.

The Origin of Disease by Carolyn and Christian Merchant, MD

The authors look at the origins of chronic illness by exploring their own family histories and recent research linking many diseases to pathogens and infections. The book challenges many of the concepts of Western medicine by looking at what actually causes diseases and how to cure them — as opposed to just managing their symptoms.

Handbook to Live Well with Adhesive Arachnoiditis by Dr. Forest Tennant

Dr. Forest Tennant, the world’s foremost expert on adhesive arachnoiditis (AA), published this handbook to explain the major causes and symptoms of AA, a progressive disease of the spinal cord. Tennant has successfully used hormone therapy and other groundbreaking treatments to stop the progression of AA, and offers a way forward for intractable pain patients to live well through self-care, exercise, good nutrition, medication and supplements.

Tender Points by Amy Berkowitz

This memoir by Amy Berkowitz details her experiences with fibromyalgia, which she developed as a young woman after a flashback to being sexually assaulted as a child. Berkowitz became convinced of a connection between the rape and her chronic illness, and found support online with other women who shared similar experiences. Berkowitz also recounts how she was mistreated — or not treated — by the healthcare system.

Fentanyl, Inc. by Ben Westhoff

Investigative journalist Ben Westhoff takes a close look at illicit fentanyl and other synthetic opioids, how they are manufactured in China and then smuggled into the United States — where they are now involved in over two-thirds of drug overdose deaths. Westhoff says U.S. drug policy is in “shambles” and poorly equipped to stop the synthetic drug trade, which requires sweeping new public heath initiatives.

The Criminalization of Medicine: America’s War on Doctors by Ronald Libby

This 2008 book remains just as relevant today as it was a decade ago. Author Ronald Libby says U.S. doctors have been turned into criminal scapegoats for the failures of the healthcare industry and the war on drugs. Doctors are prosecuted, fined and harassed by law enforcement for simple billing and record-keeping mistakes, or for treating pain with drugs that non-experts consider excessive or inappropriate.

Do You Really Need Spine Surgery? by Dr. David Hanscom

Retired spine surgeon and PNN columnist Dr. David Hanscom believes most spine operations are unnecessary and often have poor outcomes for patients. Hanscom says back pain is usually the result of normal, age-related conditions that can be addressed through physical therapy and other non-surgical methods.

Saving My Knees by Richard Bedard

In this e-book, journalist Richard Bedard shares his long journey of healing from chronic knee pain. Physical therapy and medication didn’t help and Bedard was fearful of surgery, so he started educating himself about knee pain. He learned that damaged cartilage can be healed and strengthened by simple, daily exercises.

The LDN Book by Linda Elsegood

People around the world are discovering that low doses of naltrexone (LDN) can be used to treat fibromyalgia, autoimmune diseases, chronic fatigue and depression. So why isn’t this affordable and effective drug used more widely? Linda Elsegood of The LDN Research Trust wrote this book to help educate doctors and patients about the untapped potential of naltrexone, which is currently only approved for the treatment of addiction.

Healing with CBD by Eileen Konieczny and Lauren Wilson

You’ve heard the hype about CBD. But does cannabidiol (CBD) really provide pain relief?

This book separates CBD facts from fiction by explaining what CBD is, the science behind it, where to buy quality CBD products, and potential treatments for many common ailments.

Mindfulness-Oriented Recovery Enhancement by Eric Garland

University of Utah professor Eric Garland, PhD, has developed a mindfulness training program to treat both pain and opioid dependence. It teaches people how to savor enjoyable experiences, enhance positive emotions, and stop focusing on their physical and emotional pain. Disrupting these negative habits helps people refocus their lives on more positive ways of thinking, which significantly reduces stress, opioid cravings and pain.

Chronic Pain the Drug-Free Way by Phil Sizer

Author Phil Sizer teaches pain management courses for Pain Association Scotland with an emphasis on using self-management skills such as positive psychology, cognitive behavioral therapy, stress reduction and even humor to relieve pain. Sizer has some off-beat suggestions for patients, such as “punking” pain management rules and avoiding “bubble vampires” — people who suck the energy out of you.

If there is a book or publication that's helped you manage or better understand chronic pain, let us know.

CDC Considering ‘Update or Expansion’ of Opioid Guideline

By Pat Anson, PNN Editor

When the Centers for Disease Control and Prevention released its controversial opioid prescribing guideline in March 2016, it pledged to study the impact of the guideline on patients, doctors and pain treatment in the United States.

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

Three and a half years later, after widespread reports of patient suffering, abandonment and suicide, the CDC may finally be getting around to an update. But it may not be what patients and doctors were hoping for.

In a meeting next week of the Board of Scientific Counselors (BSC) for the CDC’s National Center for Injury Prevention and Control (NCIPC), guideline co-author Dr. Deborah Dowell is scheduled to give a 30-minute presentation entitled “Background for Updating the CDC Guideline for Prescribing Opioids.”

According to the agenda for the December 4 meeting in Atlanta, Dowell’s presentation will be preceded by an update from NCIPC Director Dr. Debra Houry, who oversaw development of the opioid guideline. Presentations are also planned on overdose prevention and the formation of an “Opioid Workgroup.”

“CDC is scheduled to give a background presentation for a potential update/expansion of the CDC Guideline,” Courtney Lenard, a CDC spokesperson, said in an email to PNN. “CDC will also request that NCIPC’s BSC establish an Opioid Workgroup to provide expert input and observations on a possible update or expansion of the guideline.”

Public pressure has been building on the CDC to clarify the guideline — but not to expand it. Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioid prescribing have been widely adopted as policy by federal agencies, state governments, insurers, pharmacy chains and many doctors.

The guideline has also been applied to short-term acute pain situations, such as patients being treated for post-surgical pain or emergency room trauma. Last year, CDC Director Dr. Robert Redfield said he wanted the agency to develop opioid prescribing guidelines for acute pain and to use a new enhanced data system to track overdoses in hospital emergency rooms.

“I hope this does not become CDC Prescribing Guideline 2.0. In the original CDC Guideline, the identity of the key expert group was unknown, there were concerns over conflict of interest and secrecy, and legislatures or regulatory agencies eventually adopted the guideline and treated it as gospel despite the limitations stated in the report,” said Stephen Ziegler, PhD, a Professor Emeritus at Purdue University.

Last year the American Medical Association took a stand against the “misapplication” and “inappropriate use” of the guideline -- and adopted a resolution stating that some patients “can benefit from taking opioids at greater dosages than recommended by the CDC.”   

In April, the Food and Drug Administration warned that many patients were being tapered off opioids inappropriately, putting them at risk of withdrawal, uncontrolled pain and suicide. That was followed days later by a pledge from Redfield to re-evaluate the guideline and “clarify its recommendations.”

A clarification is long overdue. In a PNN survey early this year of over 6,000 pain patients and healthcare providers, an overwhelming majority said the guideline was harmful to patients and should be revised.

“Cannot understand or know why the CDC will not speak out on the harm done to undertreated, denied and abandoned patients,” one patient told us.

“The guidelines were written in secret, and the carnage that we predicted has come to pass,” said an emergency medicine physician.

“They should be revoked. People are suffering and committing suicide due to inability to tolerate suffering. This is inhumane,” another provider wrote. “It blemishes CDC’s reputation.”

CDC Funding AHRQ Studies

Instead of getting input from doctors and patients on the impact of the guideline, the CDC appears to be focused on more research to help expand its use. PNN has learned that the CDC is funding three new studies on the effectiveness of opioid and non-opioid therapies — essentially doubling down on previous research that found little evidence that opioids are effective for chronic pain.    

“CDC is funding the Agency for Healthcare Research & Quality (AHRQ) through an interagency agreement to conduct systematic reviews of new scientific evidence that has been published since the Opioid Prescribing Guideline was released,” said CDC’s Lenard. “The reviews will evaluate the effectiveness and comparative effectiveness of opioids, non-opioid pharmacologic therapy, and nonpharmacologic therapy for chronic and acute pain.

“Results of these reviews will help CDC determine whether evidence gaps have been addressed and if the Opioid Prescribing Guideline should be updated or expanded. If a Guideline update or expansion occurs, the development process would include consideration of findings from the systematic reviews and an additional public comment period through the Federal Register once an update or expansion is drafted.”

All three AHRQ studies were awarded on the same day – at an estimated cost of $1.1 million – to the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, which is headed by Dr. Roger Chou, one of the co-authors of the CDC guideline.

As PNN has reported, Chou is a primary care physician and longtime researcher who has publicly aligned himself with Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group that seeks drastic reductions in the use of opioid medication.  

Chou recently co-authored an article with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

Chou also consulted with PROP founder Dr. Andrew Kolodny and other PROP members for Oregon Pain Guidance, an advisory group that claims opioid tapering “will improve the quality of life for the majority of patients.”

DR. ROGER CHOU

It is not clear if PROP members are also involved in the three AHRQ studies, as they were in drafting the CDC guideline. But critics say Chou’s continuing association with PROP raises questions about his impartiality as a researcher.

“For years, we have called out a ‘False Narrative’ that prescription opioids drive the current overdose crisis; current data shows this is demonstrably false,” said Dr. Chad Kollas, a palliative care specialist in Florida. “We have not done as well calling out a “Hidden Narrative,” where PROP-affiliated physicians have wrongly influenced and encouraged the misapplication of federal policy in a way that has systematically harmed vulnerable patients in pain. We must call out their conflicts of interest loudly now.”

As a matter of policy, AHRQ does not release conflict of interest statements or disclose the names of its consultants, investigators and peer reviewers until after its reports are finalized. The AMA is recommending that the agency end that policy.

“We would suggest that AHRQ publish the list of all those involved in any aspect of the report… to help remove any perception of potential conflict,” Dr. James Madara, the AMA’s Executive Director and CEO, wrote in a letter to AHRQ. The letter also urges the agency to clearly state that the opioid epidemic was not fueled by prescription opioids and that its research should not be used to justify tapering.

Draft versions of the three AHRQ studies have been completed and were recently posted for 30 days on the agency’s website. They were removed after a public comment period ended, which is another AHRQ policy. Fortunately, PNN was able to obtain copies before the draft reports were withdrawn from public view.

• Opioid Treatments for Chronic Pain

• Nonopioid Pharmacologic Treatments for Chronic Pain

• Nonpharmacologic Treatment for Chronic Pain

What did Chou and his researchers conclude? The three draft reviews support many of the same conclusions as the CDC guideline — hardly a surprise since Chou helped write the guideline.

“For patients with chronic pain, opioids are associated with small beneficial effects versus placebo but are associated with increased risk of short-term harms and do not appear to be superior to nonopioid therapy. Evidence on intermediate-term and long-term benefits remains very limited and additional evidence confirms an association between opioids and increased risk of serious harms,” one draft says. 

“Findings of this review, with expansion of scope to include short-term trials, support the recommendation in the 2016 CDC guideline that opioids are not first-line therapy for chronic pain and to preferentially use nonopioid alternatives.”    

The AHRQ expects to release final versions of the three pain management reports in early 2020. A list of experts and informants will be released at that time, along with any conflicts of interest. 

Still unclear is what the CDC will do with the reports and what kind of “update or expansion” the agency is considering for its opioid guideline.

U.S. Life Expectancy Still Declining

By Pat Anson, PNN Editor

After decades of progress with Americans living longer and healthier lives, a disturbing new study has documented how life expectancy in the U.S. has declined for three consecutive years.

The drop in life expectancy was most pronounced in young and middle-aged adults. Starting in 2014, midlife mortality increased across all racial groups, largely due to drug overdoses, alcohol abuse, suicide, and chronic illnesses such as hypertension and diabetes. Researchers said prescription opioids were more of a symptom than a cause of premature deaths.

In 2014, Americans were expected to live to 78.9 years of age. By 2017, the average life expectancy had fallen to 78.6 years.

The U.S. now has the worst midlife mortality rate among 17 high income countries, even though it spends more on healthcare per capita than any other nation.  

“This is an emergent crisis. And it is a uniquely American problem since it is not seen in other countries. Something about life in America is responsible,” lead author Steven Woolf, MD, reported in a Special Communication published in JAMA.

The largest increases in midlife mortality occurred among adults with less education and those living in rural areas.  Changes in life expectancy were greatest in upper New England, the Ohio Valley, and Appalachia – regions where economic distress, lower social mobility and the so-called epidemic of despair contributed to rising rates of suicide and drug and alcohol abuse.

“While it’s a little difficult to place the blame on despair directly, the living conditions causing despair are leading to other problems,” said Woolf, who is director emeritus of the Center on Society and Health at Virginia Commonwealth University. “For example if you live in an economically distressed community where income is flat and it’s hard to find jobs, that can lead to chronic stress, which is harmful to health.”

While life expectancy increased in a handful of Western states, midlife mortality rose in Ohio and West Virginia – states often called ground-zero of the opioid crisis.  A sharp increase in opioid overdoses came in three waves; starting with the introduction of OxyContin and the overuse of prescription opioids in the 1990s, followed by increased heroin use, and then the emergence of illicit fentanyl – which triggered another wave of opioid overdoses starting in 2013.

“However, the increase in opioid-related deaths is only part of a more complicated phenomenon and does not fully explain the increase in midlife mortality rates from other causes, such as alcoholic liver disease or suicides. Opioid-related deaths also cannot fully explain the U.S. health disadvantage, which began earlier (in the 1980s) and involved multiple diseases and nondrug injuries,” Woolf said.

The tsunami of fentanyl overdoses has yet to dissipate. According to a new study by the Massachusetts Department of Public Health, 93% of opioid related overdoses in the state in the first nine months of 2019 involved fentanyl. Deaths involving prescription opioids such as oxycodone and hydrocodone peaked in 2014 and are now linked to only about 10% of overdose deaths in Massachusetts.

Hold the CBD and Pass the Gravy

By Pat Anson, PNN Editor

You can now buy cannabis-infused juice, beer, popcorn, gummies, breakfast cereal, and just about every food and drink imaginable with CBD or even THC.  

But you know things are getting out of hand when a company starts selling cannabis-infused turkey gravy – just in time for Thanksgiving.

KIVA Confections – a California company that makes a line of cannabis chocolates and edibles -- has introduced a “groundbreaking” turkey gravy infused with 10mg of THC, the psychoactive compound in marijuana. Thanksgiving dinner will never be quite the same.

“Awkward family dinner conversation? In just under 15 minutes you’ll start feeling the effects, so you can sit back, relax, and let the holiday cheer wash over you,” said Kiva in a tongue-in-cheek blog post

The company plans to introduce a cannabis-infused hot cocoa mix by Christmas.  

KIVA CONFECTIONS

FDA Warns CBD Companies

Federal health officials are finally blowing the whistle on cannabis marketing. The Food and Drug Administration has issued warning letters to 15 companies for illegally selling and marketing cannabis infused products.

Ironically, the FDA’s focus is not on THC, but on cannabidiol (CBD), the seemingly harmless and over-hyped compound in cannabis associated with many health claims. The FDA has revised a Consumer Update to more clearly state that CBD is not recognized as safe for use in human or animal food.

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA,” Amy Abernethy, MD, FDA Principal Deputy Commissioner, said in a statement.

“We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”

What most concerns the FDA is that CBD is being marketed as a treatment for chronic pain, arthritis, depression, addiction, anxiety and other medical conditions with no clinical evidence that it actually works.

Red Pill Medical of Phoenix, one of the companies that received a warning letter, claims CBD can cure cancer.

“We’ve seen CBD kill prostate cancer cells, kill colon cancer cells…there’s just thousands of anecdotal stories on the internet where people have cured themselves when they were told they had weeks or months to live using CBD,” Red Pill claims in a promotional video.

Another company, Whole Leaf Organics of Los Angeles, was warned about selling CBD products for pets.

“Beneficial and safe for both people and animals, CBD has been known to reduce inflammation, assist with chronic fatigue, alleviate joint and muscle pain, and help in regards to the management of stress and anxiety,” Whole Leaf claims on its website.

One company was warned about marketing CBD products for infants and children, while another was warned about selling CBD for food-producing animals such as chickens and cows.

This isn’t the first time the FDA has warned cannabis companies to be more discerning in their marketing. Similar warning letters were sent in March to three companies for making unsubstantiated health claims about their CBD oils, extracts and edibles.

One of the companies, NutraPure, now has a disclaimer on its website stating that its products “have not been evaluated” by the FDA and “are not intended to diagnose, prevent, treat, or cure any disease.” As PNN reported, however, that didn’t stop a NutraPure representative from recommending the company’s hemp oil to this reporter as a treatment for fibromyalgia.

The FDA says it will “explore potential pathways” for CBD products to be marketed legally and would be providing an update in coming weeks.

In the meantime, pass the gravy.

Cannabis Cuts Headache and Migraine Pain in Half

By Pat Anson, PNN Editor

Inhaled cannabis can significantly reduce both headache and migraine severity, according to a large new study that looked at patients who self-reported their symptoms. But researchers say the effectiveness of cannabis diminished over time, as patients used larger doses for pain relief and appeared to develop a tolerance to the drug.

Researchers at Washington State University analyzed data from the Strainprint app, which allows patients to track their symptoms while using medical cannabis. Data was collected from nearly 2,000 patients who used the app almost 20,000 times to track their headache and migraine pain before and after inhaling cannabis by smoking or vaping. The cannabis was obtained from licensed medical cannabis distributors in Canada.

"We were motivated to do this study because a substantial number of people say they use cannabis for headache and migraine, but surprisingly few studies had addressed the topic," said lead author Carrie Cuttler, PhD, a WSU assistant professor of psychology. "We wanted to approach this in an ecologically valid way, which is to look at actual patients using whole plant cannabis to medicate in their own homes and environments.”

The study, published online in the Journal of Pain, is the first to use data from headache and migraine sufferers using cannabis in real time. Previous studies have asked patients to recall the effect of cannabis use in the past.

Cuttler and her colleagues found that self-reported headache severity fell by 47.3 percent and migraine severity declined by 49.6 percent. Cannabis concentrates, such as cannabis oil, produced a larger reduction in headache severity than cannabis flower.

There was no evidence that cannabis caused "overuse headache," a pitfall of opioid medication and other pain relievers that can make headache pain worse over time. However, researchers did see patients using larger doses of cannabis over time, indicting they may be developing tolerance.

There was no significant difference in pain reduction among cannabis strains that were higher or lower in levels of tetrahydrocannabinol (THC) and cannabidiol (CBD). Since cannabis is made up of over 100 cannabinoids, the finding suggests that different cannabinoids or organic compounds like terpenes may play a central role in headache and migraine relief.

Cuttler acknowledged the limitations of using an app to collect data, since it relies on a self-selected group of people who may already anticipate that cannabis will work to alleviate their symptoms. It was also not possible to use a placebo control group.

"I suspect there are some slight overestimates of effectiveness," said Cuttler. "My hope is that this research will motivate researchers to take on the difficult work of conducting placebo-controlled trials. In the meantime, this at least gives medical cannabis patients and their doctors a little more information about what they might expect from using cannabis to manage these conditions."

PNN columnist Mia Maysack, who suffers from chronic migraine and cluster headache, reluctantly agreed to try cannabis after her first cluster headache lasted 54 straight days. Mia said she “almost instantaneously felt better.” Now she uses cannabis regularly.

“It helps me combat nausea, cultivate an appetite, gives a slight boost in morale, and get quality rest,” Mia wrote in a column. “Cannabis works for me about half the time.  But that goes deeper than a glass half empty or half full.  It's a matter of having a resemblance of a life or not.”   

Criminalizing Pregnant Women for Drug Abuse Is a Terrible Idea

By Dr. Lynn Webster, PNN Columnist

According to Guttmacher Institute, nearly half the states in the United States are willing to punish pregnant women in order to spare their babies the agony of being born with Neonatal Abstinence Syndrome (NAS). Ironically, their efforts are having the opposite effect.

Twenty-three states and the District of Columbia have passed legislation that criminalizes substance abuse during pregnancy. Additionally, 25 states and the District of Columbia require healthcare providers to report expectant mothers who may be illegally using substances. In 8 states, pregnant women who are suspected of substance abuse must also undergo drug testing.

The huge number of babies born to mothers dependent on opioids has driven policymakers to find ways to deter pregnant women from abusing opioids.

But new research points out there are unintended consequences to criminalization. And it provides lawmakers insight on how to create more effective policies that result in positive, not punitive, outcomes.

A study published recently in the journal JAMA Network Open examined 4.6 million births in the U.S. from 2000 to 2014. During this time, the diagnosis of NAS increased seven fold.

The study was conducted by the RAND Corporation, a nonprofit research institute that analyzed 8 states with punitive policies for drug-abusing pregnant women. The research was funded by the National Institute of Drug Abuse.

According to a RAND press release, Arkansas, Arizona, Colorado, Kentucky, Massachusetts, Maryland, Nevada and Utah adopted either punitive penalties for drug use during pregnancy or policies that required health care providers to report pregnant women with suspected illegal substance use.

RAND researchers found that the annual rate of NAS increased in the 8 states, from 46 cases per 10,000 live births to 60 cases per 10,000 after punitive policies were enacted. That is an alarming 30% increase in NAS cases.

This is not the first study that has shown political efforts to curb opioid addiction and overdoses have not had a positive impact. We have seen the harm associated with forced tapers and dose limits adversely affecting millions of pain patients.

It is hard to understand why these destructive policies are put in place, but it may be because policymakers are misinformed or biased. Regardless, it reflects a systemic flaw for governments to fail to evaluate the efficacy and outcomes of the very policies they create.

Addiction Is a Disease, Not a Crime

How best to address addiction has long been the subject of debate. For example, a state hospital in South Carolina illegally obtained the diagnostic tests of pregnant women in an effort “to obtain evidence of a patient's criminal conduct for law enforcement purposes” (this was the case of Ferguson v. Charleston).

Unfortunately, some people still believe that addiction is a volitional or character flaw that should be recognized as criminal behavior rather than a disease.

Indisputably, addiction is a complicated, life-threatening disease. Treating people with the disease as criminals is the worst possible approach. Most experts in the substance abuse treatment community have known this for years. Fortunately, the RAND Corporation has now provided evidence of how this applies to babies born to women who abuse opioids. 

Typically, lawmakers do not evaluate the impact of the policies they pass. There have been many policies over the past few years that were implemented by state legislatures, healthcare organizations and insurance companies that were intended to reduce harm from opioids. Almost no one has attempted to measure their effectiveness or unintended consequences.

Fortunately, in this case, we have an exception. We have a unique opportunity as a result. The RAND study should provide policymakers with insights on how to more effectively address the problem of substance abuse during pregnancy.

Threatening to punish a pregnant women does not decrease the number of women who abuse drugs. However, it does scare many of them away from seeking the treatment they need and can deter pregnant mothers from seeking prenatal care.

Pregnant women who are opioid-dependent frequently use other illegal substances that risk the health of their babies. There should not be more barriers for pregnant women to receive prenatal care. Infants born after exposure to opioids often require prolonged hospitalizations to manage their needs, with those cumulative costs totaling more than $500 million, according to the RAND study. More importantly, babies with NAS suffer needlessly.

It should go without saying that every policymaker wants to solve problems and not create additional harm for new mothers or to babies born to them. Hopefully, this study will be used as it is intended: to help create policies that actually reduce harm from opioids. 

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

You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences or Pain News Network.