Severely Injured? Don’t Count on Getting Opioid Pain Medication

By Madora Pennington, PNN Columnist

When I went to Cedars-Sinai Urgent Care in Los Angeles recently, screaming and crying, my blood pressure dangerously high, my foot ballooning and turning blue from a household accident, the doctor wouldn’t give me opioid pain medication.

They x-rayed my foot. Two bones were broken. They gave me a shot of a NSAID that, they said, would wear off in a few hours. It did. They gave me crutches, a boot to immobilize my foot, suggested I see a surgeon and, in the meantime, take Advil. What?

It wasn’t personal. This is Cedars-Sinai’s policy. In urgent care, they won’t give opioids to anyone for any reason.

I had gone to Cedars-Sinai because I have a complex medical history. There, my records are most complete. This makes the appointment easier for the doctor and me.

Also in my records is my long-term opioid use history. I was on Vicodin and morphine daily for about six years, to treat chronic pain from Ehlers-Danlos syndrome, a rare genetic disorder that causes all the joints to be loose, or rather, permanently sprained.

When I started on daily opioids, an option no longer available, I had pain that I could not live with, no quality of life and was planning my suicide.

Those drugs gave me enough relief to endure. I became less of a burden to my caretaker. I could focus on trying to improve my health. If your day is spent fighting extreme pain, being productive is not possible.

Then I got very lucky.

In 2014, experimental treatment had improved the strength of my tendons and ligaments. My body hurt less. I went straight off the opioids and stayed off.

Withdrawal was a harrowing marathon of torture. For years after, I suffered from the physical damage opioids left behind. But I didn’t go back on them because I had never become addicted. Why? I had been warned at the start of my opioid treatment to take the drugs for physical pain only, not for emotional relief. This patient follows orders.

As a result of the war on opioids, many chronic pain patients are being denied adequate pain relief. Some forced to taper end up committing suicide from the agony of withdrawal plus untreated pain. This became such a problem, the U.S. Department of Health and Human Services issued new recommendations in October, advising doctors to look at each case individually and not to put patients on rapid opioid tapers or abruptly discontinue them.

But I had never heard of someone with a severe, acute injury forced to suffer. Even I can’t be trusted? I have a proven record of responsible opioid use with no addiction.

The doctor treating my injured foot, clearly embarrassed, told me, “This is urgent care. If it’s something severe, the patient should be in the ER or at a pain doctor.”

But I had called before I came. “Would they see me for a possibly broken foot?”

The receptionist said to come in, they would x-ray me right away. She didn’t say I would not be given adequate pain medication.

Has the war on opioids gone too far? If doctors and hospitals are too afraid of lawsuits or prosecution to prescribe, then yes.

A Mayo Clinic study found that only about 1% of patients given opioids in emergency rooms went on to long term use. Another study found less than 1% of patients being treated with opioids for post-surgical pain developed dependence or abused opioids. Does that mean the other 99% of us should not get pain medication?

Not according to the CDC, which suggests three days of opioids for acute injuries like mine.

After I left urgent care that day, I took Vicodin which had expired a year before but I’d never gotten rid of. If it hadn’t worked, I would have had to call an ambulance and gone to the ER that night, just for pain treatment.

After surgery, the podiatrist told me, “One bone was in pieces. I bolted together what I could. Some bits were too small so I picked them out and threw them away.” Well, that explains the pain I’d been in.

I vowed never to leave things on the floor that someone might trip on. And I set up Google Home to process a command to make a phone call for help.

I also filed a complaint with the state against the doctor. Medical care is about the patient, not hospital bureaucrats.

Madora Pennington writes about Ehlers-Danlos and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

Domestic Abuse Survivors Have Twice Risk of Fibromyalgia

By Pat Anson, PNN Editor  

Ava Shypula had a difficult childhood growing up in communist Poland. She was physically abused by her father and was left home alone for hours, sometimes days at a time. Ava became chronically ill at a young age. 

“My symptoms began very early, almost as far as I remember. They started with joint pain, chills and constant flu like symptoms, with a sore, inflamed throat,” Ava recalls. 

Even after marrying a doctor and leaving Poland to begin a new life in New York City, Ava’s symptoms persisted. 

“My then-husband ignored my symptoms, focusing on his own career and studying in order to re-certify his medical diploma,” she said. “The fear of failure, pride and ambition to succeed only advanced the illness, which at that time was diagnosed as chronic fatigue syndrome.” 

Only after her marriage ended in a nasty divorce did Ava begin to understand her illness and the role played by stress. She was diagnosed with fibromyalgia – a poorly understood disease characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. 

A neurologist prescribed Lyrica and Ava’s symptoms began improving. 

“For many years women with undiagnosed fibromyalgia had been dismissed as hysterics having emotional issues,” she said. “Together with a fantastic help from my psychiatrist, my symptoms slowly but noticeably diminished, not fully, but they have become more manageable.”

Abuse Causes Physical and Psychological Stress

Ava Shypula’s story is not unique. In fact, it is all too common, according to a large new study that found female survivors of domestic abuse have nearly twice the risk of developing widespread body pain and chronic fatigue syndrome (CFS).

Researchers at the Universities of Birmingham and Warwick in the UK examined the medical records of over 18,500 women who suffered domestic abuse and compared them to 74,000 women who did not. Health data was collected from 1995 to 2017.

The study, published in the Journal of Interpersonal Violence, is one of the first designed to assess the relationship between women who have been abused and the likelihood of them developing long-term illnesses such as fibromyalgia.

"Survivors of domestic abuse can experience immense physiological and psychological stress,” said Professor Julie Taylor of the University of Birmingham's School of Nursing. “The changes that happen in the body as a result of such stress can lead to a multitude of poor health outcomes such as what we see in our study here.

"This is a very complex relationship and it is important to emphasize that not all women who have been abused will develop fibromyalgia or CFS, and that having these conditions does not mean there has been domestic abuse in the past."

Previous research has found that about one in every four women in the UK have experienced some form of domestic abuse, with a large proportion of those cases being violence at the hands of an intimate partner. Globally, about one in three women suffer domestic abuse.

"Considering the prevalence of domestic abuse, and the fact that patients experiencing fibromyalgia and CFS often face delays in diagnosis due to a limited understanding generally of how these conditions are caused, it is important for clinicians to bear in mind that women who have survived abuse are at a greater risk of these conditions,” said Dr. Joht Singh Chandan of the University of Birmingham's Institute of Applied Health Research and Warwick Medical School.

"We hope these first of their kind research findings will change healthcare practice and will be of assistance in the early diagnosis of fibromyalgia and CFS in women who have been abused."

Ava Shypula hopes that sharing her story will help other women understand their illness, get treatment and make lifestyle changes to reduce stress. She’s learned that avoiding cold temperatures, staying warm and getting a good night’s sleep will reduce her symptoms. 

“Encourage them to fight back instead of resigning and living with pity and depression, which I have experienced at different points of my life,” she told PNN. “I have found that emotional support plays a major role to fight with this illness.”

Patient Who Can’t Find Doctor in Texas Flies to California for Pain Care

By Lori Ravellli, Guest Columnist

I am writing to ask for a change in attitudes toward people in pain who need improved access to treatment. I want my voice to be heard when actions are taken to curb the opioid abuse problem.

I need help. I suffer and have suffered for years from severe chronic lower back and coccyx pain that is unbearable. Some of the conditions I have been diagnosed with are chronic pain disorder, lumbar spondylosis, hypertrophic set arthropathy, degenerative disc disease, lumbar nerve root disorder and scoliosis. I honestly do not know what all of this means but I know how bad it hurts.

I also had a gastric procedure which limits the kinds of medications I can take, such as ibuprofen, muscle relaxers, naproxen and NSAIDs.

I have had multiple appointments with neurosurgeons and other doctors, who say I have too much wrong with my lower back to have any surgical procedure. I have stacks of reports and test results justifying my issues. I have had multiple injections with different medications and locations to drain my bank account, gain weight and still suffer in agony.

My only option is pain management through medication. I cannot sit down for any length of time and lying down hurts. I can only stand for so long without my legs giving out. In addition to that, I have shooting pain down my leg when I do sit.

Sadly, as much as a body needs rest, I can no longer rest comfortably. My quality of life is almost nonexistent due to the debilitating pain. Without relief, I really contemplate ending my life. I can no longer deal with the agony.

LORI RAVELLI

I do not want my friends and family to grieve because I took my life due to pain and lack of treatment. Chronic pain patients visit their doctors often, are subject to drug tests, and are not the reason there is a crisis in this country. Doctors being too scared to treat patients is not fair to us.

The problem is so bad here in Texas that doctors do not want to care for pain patients. I moved to Texas two years ago and have struggled to find care and treatment. I have been forced to fly back to my old doctor in California to get medication. My doctor I saw for many years knows me, knows I do not over-medicate, and has never needed to raise the dose of my medication.

I cannot believe that I am not able to find a doctor to treat me here in Texas. Sitting is so painful and it is a struggle to fly 3 hours for a doctor’s appointment. I have to sit in the car an hour, sit in the airport for 2 hours, and then the flight for 3 hours. Sitting is so painful because of my back and pain shooting down my leg.

By the time I arrive, I am in such horrific pain it takes days to recover. I am so tired of living in agony. This is so wrong and it is my human right to have some pain relief because it is available. 

The real problem seems be addicts that purchase medication from the streets and not knowing what they are purchasing. When people are not able to get their medication from the proper channels, they will seek options from the street with hope of finding some relief.

Pain relief is a human right and without relief people will take their lives. Living with debilitating pain you have no quality of life and no reason to wake up in the morning.

I am tired of being treated like a drug addict. I am suffering severely and need medication to be a functioning adult. I know I will never be pain free, but any relief is welcomed. Please, please for the love of God stop punishing the patients and the medical professionals trying to help them!

Lori Ravelli lives in Galveston, Texas.

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.

Opioids Are Not the Only Pain Meds That Can Be Abused

By Dr. Lynn Webster, PNN Columnist

Contrary to popular opinion, opioids don't cause substance abuse. Opioids certainly may be abused, but it is human biology itself that drives drug abuse.

We often get the message that any other pain treatment would be better than using opioids. However, even non-opioids prescribed for pain can contribute to overdoses and suicides. The same genetic and environmental factors that cause opioid abuse can induce abuse of other drugs, too.

For several years the number of opioid prescriptions has declined significantly, due to public demand and political pressure. According to the IQVIA Institute, there was a 17 percent decrease in the number of opioids prescribed in 2018 alone.

We may have expected that to translate into fewer drug abuse problems. Instead, we have seen an increase in overdoses, hospitalizations and suicides involving non-opioids such as gabapentin, methamphetamines and muscle relaxants.

Less access to prescription opioids has driven some people in disabling pain to seek illegal alternative medications. That has led to a wave of use and abuse of drugs that doctors have not prescribed.

Between 2016 and 2017, the CDC reported a nearly 47% increase in fentanyl-related deaths. Overdoses related to methamphetamine and cocaine have also surged.  

According to Stateline, approximately 14,000 cocaine users and 10,000 meth users died in the United States in 2017, triple the number of deaths in 2012. Deaths involving have heroin also spiked since 2010.  

Gabapentin and Baclofen 

Prescription drugs, too, have fueled the negative statistics. Doctors have felt forced to taper or discontinue opioids. In an attempt to find alternatives for pain management, they have increased the number of gabapentin and baclofen prescriptions. 

As PNN has reported, a recent study published in Clinical Toxicology found a “worrying” increase in calls to U.S. poison control centers about gabapentin (Neurontin) and the muscle relaxer baclofen, coinciding with a decrease in opioid prescriptions. The study analyzed more than 90,000 cases of exposure to gabapentin and baclofen, many of which were coded as suicides or attempted suicides.

“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.”  

Gabapentin is one of the most commonly prescribed drugs in the United States. It is prescribed for epilepsy, hot flashes, migraines, nerve damage, and more. It is also used to treat the symptoms of drug and alcohol detoxification, and to treat pain for patients at higher risk of addiction to opioids.  

Baclofen is a muscle relaxant that has also been substituted for opioids. Other non-opioid drugs such as pregabalin and NSAID’s are being increasingly prescribed as well.  

All Medications Have Risks 

Non-opioids have a role to play in pain management, but it is just as important to understand their dangers. While we need effective alternatives to opioids, it is important to know that alternatives also have risks. That is unavoidable, because all medications carry potential benefits and consequences.  

To decide whether a medication is appropriate for an individual, it is critical to determine whether the potential benefit outweighs potential harm. Gabapentin and baclofen are not bad drugs, but they are not harmless replacements for opioids, either.  

No pain medication, whether it is an opioid or non-opioid, is right for everyone under all circumstances. The next time a physician or nurse practitioner suggests replacing an opioid with gabapentin, baclofen, or another medication, it would be appropriate to ask for a comparison of the risks and benefits. 

Talking with your healthcare provider about your preference for a particular medication does not make you a drug seeker. It helps you become an informed patient. 

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. 

FDA Approves Generic Gilenya for Treatment of MS

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first generic versions of Gilenya (fingolimod) for the treatment of relapsing forms of multiple sclerosis (MS). That’s welcome news for patients who have long struggled with the exorbitant cost of many MS medications.

A 30-day supply of Gilenya 0.5mg capsules currently costs about $8,130, according to Healthcare Bluebook, or about $97,560 a year.

“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines.”

The FDA approved generic fingolimod applications from HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.

Until now, Novartis held the exclusive patent rights to fingolimod, which is sold under the brand name Gilenya. Nearly 300,000 people worldwide have taken Gilenya since it was approved by the FDA in 2010, according to Novartis.

MS is a chronic and progressive disease that attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. For most people with MS, there are periods of remission followed by relapses or flareups as the disease progresses. Gilenya is a widely used treatment for relapsing MS.

Generic formulations are often significantly cheaper than brand name drugs. In July, the FDA approved the first generic forms of Lyrica. Today a two-month supply of Lyrica costs about $472, while the same amount of generic pregabalin costs just $21.

Maximizing Profit

Criticism about the high cost of branded MS drugs is growing. Last month when the FDA approved a new MS medication called Vumerity, drug maker Biogen set its wholesale price at $88,000 a year. That brought a rare rebuke from the National Multiple Sclerosis Society, which released a statement that accused Biogen of price gouging.

It can take years for a new drug to get FDA approval and the pharmaceutical industry has long claimed that it needs to set prices high to recover the cost of research, clinical studies and drug development.

That claim is discounted in a recent article published in the journal Neurology, in which researchers asked four drug industry executives about the high cost of MS drugs. The executives were given anonymity to encourage them to speak freely.  

"I would say the rationales for the price increases are purely what can maximize profit," one executive said. "There's no other rationale for it.”

In setting the price for a new drug, executives said they primarily look at what their competitors are charging for similar medications. Companies fear that undercutting competitors with a lower price would undermine the attractiveness of their product.

"We can't come in at less," one of the executives said. "That would mean we're less effective, we think less of our product, so we have to go more."

The problem is unique to the United States, the only developed country that doesn’t have a universal healthcare system that regulates prices.

"And it is only in the United States, really, that you can take price increases. You can't do it in the rest of the world. In the rest of the world, prices decline with duration in the marketplace," another executive said.

Researchers say their study provides new insight into the economics behind pharmaceutical pricing.

"The frank information provided by these executives pulls back the curtain of secrecy on how drug price decisions are made," said co-author Dennis Bourdette, MD, chair of neurology at the Oregon Health & Science University School of Medicine. "We see that it is indeed the race to make more money that is driving up drug prices and nothing more."

In the meantime, MS patients like Jennifer Hochgesang struggle to make their co-payments and deductibles. She gets injections of glatiramer acetate, a generic version of Copaxone.

“It costs over $5,500 a month. When you add my migraine medication and other medications, it adds up to over $13,000 a month. I reach catastrophic level by March in my insurance and that’s the only way I can pay for it,” Hochgesang said. “It doesn’t cost that much in Europe though and it shouldn’t cost that much here.

“It seems sick to me that companies use a drug like this to profit highly from, when people can’t reasonably afford five thousand dollars a month. I believe an MS drug should be accessible to anyone. Otherwise we are only creating medicine for the rich and those able to get insurance or be on disability, leaving the rest out in the cold. That just isn’t right.” 

Living Well With Fibromyalgia

By Lynn Phipps, Guest Columnist

In 2016, as a guest columnist for PNN, I shared my story of being diagnosed with fibromyalgia and the offending ways I was treated by the medical community for having an invisible illness.

If my first column was about finding hope, then this one is about getting well and living well with fibromyalgia. I hope that you will be inspired by my story and know that there is a way for you to reclaim your lives from the devastating illness that is fibromyalgia.

For years I felt alone. I am not alone. Neither are you.

In 2003, I knew something was very wrong when I could no longer effectively do my job as a social worker. ​I was in constant pain, had a 24/7 headache and migraines twice a week or more, and could not fully concentrate. Insomnia and anxiety had me awake most nights.

Desperate to get well, I spent half of my paycheck on herbs, supplements, massage, hydrotherapy, acupuncture, chiropractic, ​Rolfing​and Reiki​. Nevertheless, I continued getting worse. When I could no longer afford alternative treatments not covered by my health insurance, my body crashed.

Having suffered from unrelenting migraines for months, my final career ending moment came when my back and neck spasmed, causing me to fall to the floor in my office at work. I remained on hands and knees for 20 minutes before being able to crawl to my desk to pull myself up.

I do not remember driving home, nor did I realize that moment signaled the end of my 20-year career as a social worker caring for those with disabilities (ironic, I know).

I was diagnosed by my doctor with fibromyalgia, chronic pain, severe headaches and migraines, light and sound sensitivity, depression, insomnia, anxiety and PTSD. 

The Guaifenesin Protocol

LYNN PHIPPS

Over the next decade, it became my job to research and find help for my condition. The problem was that none of the specialists looked at fibromyalgia as a cause for all that I was experiencing. And not one physician ever looked at food allergies or diet as a potential cause, even though I have a family history of diabetes.

That is significant because 44% of “fibromyalgics” also have a second and separate disease called hypoglycemia.  Another 15% of fibromyalgics have hypothyroidism, another disease with overlapping symptoms, including fatigue, muscle pain and impaired memory, to name just a few. I am unlucky enough to have this grand trifecta of illness. 

With nearly all hope gone, an internet search for headache specialists in northern California led me to Dr. Melissa Congdon, a fibromyalgia specialist. ​​It was through her that I finally understood that the headaches and migraines were related to the fibromyalgia, and not whiplash from a car accident or a repetitive motion injury from work, as every doctor and specialist had assumed. 

During my first appointment, my fibromyalgia diagnosis was confirmed by Dr Congdon. I was also diagnosed with hypoglycemia. Again, this is significant because about half of us with fibromyalgia also have hypoglycemia, with overlapping symptoms such as fatigue, pain and impaired memory.

In order to get our health back, these two separate diseases require two separate treatments: Dr R. Paul Saint Amand’s Guaifenesin Protocol and his HG Diet for fibroglycemia.,

The protocol requires taking the expectorant drug guaifenesin (Mucinex), which clears airways in the lungs and helps the kidneys reduce the buildup of inorganic phosphates in the body. The low-carbohydrate diet combats low blood sugar, which mimics many fibromyalgia symptoms.

Within 2 months of following the protocol and diet, I began to see improvement in generalized body pain, headaches and migraines, chronic fatigue and brain fog. After 20 months, I got “me” back, and so did my family. 

Many people have mentioned that they do not want to follow the protocol because they have heard that it will make them feel worse. To this we say, “It’s pain with a purpose.”  We strive for finding our own individual dose of guaifenesin that will leave us “functionally” worse, not incapacitated. As long as we do nothing, the phosphates will continue to accumulate throughout the body, causing fibromyalgia symptoms to continually worsen.

The Guaifenesin Protocol will clear the offending phosphates from our kidneys at a rate of approximately​ ​1 year of symptoms in just 2 months. I was symptomatic for 10 years before starting the protocol and had reversed all of my symptoms within 20 months. By the first year on the protocol, I was off of all pain medication. 

My Awakening

The 13 years that I spent bed-bound seem like a bad dream. It was quite an adjustment getting my health back after so much time. It felt as if I’d been existing in a semi-comatose state. While I’d been so ill, my mother passed from pancreatic cancer and both daughters moved out, graduated from college and started their adult lives. 

I had physically been there for all of that, but with such severe fatigue and brain fog, it all had a feeling of unreality to me. Upon “awakening” I was shocked by my appearance, as I’d been only 38 when I got sick and had “awakened” at age 51. My husband and I had to get to know each other all over again. Luckily, we fell in love all over again. 

After the brain fog and severe fatigue had cleared, I wanted to go back to work, but I knew that I could not be a social worker again. Many fibromyalgia symptoms are brought on by physical or emotional trauma. The stress of being a social worker ruled that out, so I decided to do something quite different. I put my years of watching HGTV while bedbound to use by becoming certified in home staging and redesign.  I enjoyed a successful home staging business for 3 years before retiring.

I now spend my days educating others on the Guaifenesin Protocol, helping those still suffering from fibromyalgia get their lives back, too.

(Editor’s note: For a contrarian view on the Guaifenesin Protocol, click here.)

Lynn Phipps lives in northern California. Lynn has created a website called Living with Fibromyalgia to assist beginners in getting started on the Guaifenesin Protocol.

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

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.

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.