Drug Legalization Needs to Consider Drugs That Haven’t Been Invented Yet

By Roger Chriss, PNN Columnist

Drug decriminalization and legalization have become hot topics in the U.S. and around the world. Some states have legalized recreational cannabis and a handful of cities have decriminalized psilocybin, a hallucinogen found in some mushrooms. Countries like Portugal have decriminalized all drugs.

The arguments in favor of legalization seem reasonable, from harm reduction and de-stigmatization to access to a well-regulated supply of substances that people are going to use regardless of whether they are legal or not.

But rarely are questions asked about the drugs that haven’t been invented yet. Debate about legalization usually centers on popular but controversial substances like cannabis, with no mention of novel fentanyl analogs or other new psychoactive substances.

Novel opioids appear on the dark web regularly. For instance, the potent synthetic opiod isotonitazene is now being sold online, even though a team of international researchers said it “represents an imminent danger.”

Public health officials in the U.S. also recently warned about isotonitazene in the journal NPS Discovery, after the drug was identified in blood samples from eight overdoses deaths in Illinois and Indiana.

“Pharmacological data suggest that this group of synthetic opioids have potency similar to or greater than fentanyl based on their structural modifications,” they warned. “The toxicity of isotonitazene has not been extensively studied but recent association with drug user death leads professionals to believe this new synthetic opioid retains the potential to cause widespread harm and is of public health concern.”

Similarly, there are reports on overdoses with cyclopropylfentanyl, a chemical cousin of fentanyl that first appeared in Europe in 2017.

“The constantly growing diversity of NSO (new synthetic opioids) still poses a high risk for drug users and can be a challenging task for clinicians and forensic toxicologists. Clinicians treating opioid overdoses should be aware of the potentially long lasting respiratory depression induced by fentanyl analogs,” German researchers said.

Novel Substances

This problem is not limited to illicitly manufactured fentanyls and other opioids. Novel synthetic cannabinoids also pose risks. Such compounds include JWH-018 and AKB48, both known to be dangerous.

And the world of hallucinogens, amphetamines and other psychoactive substances is evolving, too. Psilocybin can now be harvested from bacteria and over 150 synthetic cathiones-- amphetamine-like psychostimulants -- have been identified in clandestine drug markets.

“Over the past hundred years or so, humankind has learned to synthesize the active chemicals in laboratories and to manipulate chemical structures to invent new drugs—the numbers of which began growing exponentially in the 2010s,” Ben Westoff notes in Fentanyl, Inc.

Further, drug consumption technology is changing rapidly. Just as the hypodermic syringe forever changed the risks of heroin, vaping devices are having similar effects. They allow for high-intensity consumption of nicotine, THC, and other drugs that contain unknown contaminants, as seems to have happened with vitamin E acetate in the recent outbreak of lung illnesses associated with vaping.

Lastly, there are risky interactions that can occur with the use of novel substances. The American Council of Science and Health points to the particularly important issue of drug-drug interactions. The world of street drugs now involves so many adulterants and contaminants that, when combined with novel substances, drug-drug interactions are potentially more dangerous than ever.

Historically, legalization of drugs has not led to a net public health benefit. And that was when “drugs” consisted of plant matter or distilled liquids. Modern technology means we can do much better, which in turn means we may be facing far worse.

The greatest risks arguably come from the drugs that have yet to be invented and the interactions that have not been discovered. Any discussion of full drug legalization needs to consider such possibilities.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

Backlash Against Nurse Who Mocks Patients for Faking Illness

By Crystal Lindell, PNN Columnist

You may have seen it by now. In a short, 15-second video, a nurse plays herself as well as a patient, who appears to be coughing and having trouble breathing. In the video, the nurse starts dancing and ignoring the patient.

The caption reads: “We know when y’all are faking.”

I have to tell you, it’s infuriating to watch.

I’m also wondering what she thinks would be the motivation to fake a cough. It’s not as though they typically treat coughs with pain medication. Is it because she thinks the patient just wants attention? Is that what’s happening?  

As a chronic pain patient who has been in and out of hospitals and doctor’s offices over the years, it’s my worst nightmare. To have a medical professional ignore me and my very real pain because they think they possess some special power that allows them to know with 100 percent certainty that someone is faking.  

I’m not alone in my outrage. The video inspired a viral hashtag, “PatientsAreNotFaking” with countless people sharing why the video wasn’t just annoying, but also dangerous.

Of course. I have my own stories. Doctors and nurses have brushed me off. There were the countless ER doctors who insisted that my multiple visits for abdominal pain were simply heartburn. One doctor even said to me, “It’s not your gallbladder.” 

It was my gallbladder.  

There was also the nurse who ignored my pleas for help after giving me a shot of pain medication that immediately made me nauseous. She told me to “drink some water” and sent me home instead of giving me an easy anti-nausea shot.

I threw up three times on the drive home and then multiple times for the next 10 hours. It was one of the worst nights of my life.  

And then there was the rheumatologist years ago who so easily could have caught my hypermobile Ehlers Danlos syndrome. I had gone to see him because of my unexplained rib pain, and as he examined me, he moved my leg, looked up and said, “Your knee isn’t supposed to bend that way.” Then he shrugged and told me that nothing was wrong with me.  

It would take four years before I finally got the hEDS diagnosis that explained my daily, debilitating chronic pain. 

But let’s take things one step further. Let’s enter the world of the video. Let’s assume patients are faking. So what? What’s the worst-case scenario? Medical professionals have to, God forbid, check in on a patient? Isn’t that their job anyway? 

This issue especially hits close to home for chronic pain patients. Every medical professional’s worst fear seems to be that they’ll give opioids to someone who just needs them because they’re addicted. And I have to ask, again, so what?  

Here’s the two scenarios if you give someone opioids in that situation: 

1. They aren’t faking and you’re helping someone who’s dealing with legitimate physical pain.

2. You’re giving a safe, controlled supply of opioids to someone who’s suffering from such awful withdrawal that they have resorted to trying to get to pain medication at an ER. Oh no! That might accidentally help someone? The horror!

Yes, giving pain medication to people dealing with addiction could lead to a flood of patients in the ER asking for opioids. Honestly, that’s why I support making hydrocodone OTC. It would keep people who are dealing with minor pain out of the ER, as well as those dealing with addiction and withdrawal. It might also prevent many of the overdoses caused by people buying counterfeit drugs off the street. 

The thing is, it’s human nature to assume someone is faking. It’s actually a defense mechanism. Medical professionals see so many sick people in their work that for many the only way they can cope is to convince themselves that most of them are probably faking. It’s much easier to believe that than it is to believe that so many people are suffering.  

The other issue is that people’s instincts are awful. They are often based on subconscious prejudice that they may not even realize is a factor. It’s human nature to separate yourself from other groups as a form of self-preservation. Unfortunately, that leads to a lot of medical professionals assuming that any patient complaining of pain is probably faking it. 

The fact that the nurse who made this particular video, Danyelle Solie, did nothing but double down when faced with criticism shows how poorly-matched she is her for job.  Solie told a Canadian website she’s worked in healthcare for five years.

“I absolutely will not be bullied into apologising or deleting a video because some people disagree with me,” she said in a Tweet thread. “Humor has always been what made me stand out to the people I work with and the patients I help.”

Solie regularly posts comical videos online using the name “D Rose.” Some videos make fun of herself and others make fun of patients or the healthcare system in general. The one about patients faking has been viewed about 15 million times. 

We should expect more from medical professionals. They should be able to wade past their subconscious instincts and make an effort to treat patients fairly. They also shouldn’t joke about such dangerous things.  

And when in doubt? Here’s some advice to all the medical professionals out there: Just assume the patient is telling the truth. Trust me, it’s what you’ll want when you get sick.  

Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. She has hypermobile EDS.  

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.

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. 

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.

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.

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. 

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.

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. 

Little Evidence to Support Rescheduling of Tramadol

By Roger Chriss, PNN Columnist

The consumer watchdog group Public Citizen has petitioned the FDA and DEA to “upschedule” the opioid painkiller tramadol. The DEA set tramadol as a Schedule IV drug in 2014, and the petition urges moving it to a more restrictive Schedule II, on the same risk level as hydrocodone and oxycodone.

The petition claims that tramadol is “an increasingly overprescribed, addictive, potentially deadly narcotic.” But the basis for this claim and the assumption that upscheduling will help are problematic.

The CDC reports that there were approximately 1,250 fatal overdoses involving tramadol in 2017, the most recent year for which data is available. Like most fatal overdoses, tramadol deaths often involve multiple drugs, so it’s hard to draw any conclusions from those deaths.

Tramadol is complex, with a highly variable patient response. Some patients have such a strong negative reaction to the drug that they refuse to take it again. Others find it too sedating at high doses or too weak to provide adequate pain relief. Abuse, addiction and overdose can also occur with tramadol.

Recently Harvard Health looked at a JAMA study on the risks of using tramadol versus other pain relievers. Tramadol was found to have a higher risk of death than anti-inflammatory medications such as naproxen (Aleve), while people treated with codeine had a similar level of risk.

“However, because of the study’s design, the researchers could not determine whether tramadol treatment actually caused the higher rates of death. In fact, the patients for whom tramadol is prescribed could make it look riskier than it truly is,” said Robert Shmerling, MD, an editor at Harvard Health.

Unintended Effects of Upscheduling

Understanding the effects of upscheduling is tricky. In 2014 the DEA reclassified hydrocodone (Vicodin) from Schedule III to the more restrictive Schedule II. The reclassification accelerated a trend that was already underway – hydrocodone prescriptions had been falling since 2011.

But there were unintended consequences to upscheduling. A recent University of Texas study found that decreases in hydrocodone prescribing after its rescheduling “were larger in patients being treated for cancer.”

Anotherr study found that upscheduling led to a substantial decrease in hydrocodone prescribing in hospital emergency departments, but that was offset by an increase in prescriptions for codeine and anti-inflammatory drugs.

Upscheduling hydrocodone has also had a negligible effect on overdoses, which are largely caused by illicit fentanyl, heroin and other street drugs, as well as non-opioid medications such as Xanax.

Similarly, predicting the impact of new prescription opioids is difficult. Breathless warnings about the opioid Zohydro, which was approved as a Schedule II drug in 2014, proved false. “There was no great surge of overdoses” after Zohydro was introduced, as Chris MacGreal wrote in his book “American Overdose.”

Fears about opioids are also delaying the introduction of safer medications. The experimental opioid NKTR-181 has less abuse potential than traditional opioids, but its approval is uncertain because the FDA has stopped all advisory committee meetings on opioid analgesics.

Public Citizen ignores all this. It also fails to mention other actions the FDA could pursue, from making naloxone into an over-the-counter drug to improving access to medication-assisted therapy for opioid use disorder. There’s no petition to have the DEA “nix the wavier” for buprenorphine (Suboxone) to make it more widely available or to have the federal government promote the Pain Management Best Practices Inter-Agency Task Force report.

Finally, there’s no call to monitor outcomes. As PNN has reported, opioid tapering has had tragic unintended consequences. And a new Cochrane review on the effects of educational and regulatory efforts targeting prescribers was unable to draw any conclusions “because the evidence is of very low certainty.” The authors could find only two relevant studies that assessed prescribing policies adopted in the 1990’s.

There are good reasons to be cautious about tramadol. But there are probably better ways than upscheduling to reduce risks and improve outcomes. As a result, Public Citizen's petition seems quite narrow and unlikely to help with the overdose crisis.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

EPA Decision Will Stifle Animal Research on New Pain Treatments

By Dr. Lynn Webster, PNN Columnist

People in pain rely on scientific advances to find safer, more effective alternatives to opioids. Animal research is key to many of our advances in drug development.

But a recent announcement from the Environmental Protection Agency threatens to change that -- by inhibiting science’s ability to replace opioids and create new life-saving pain interventions.

EPA administrator Andrew Wheeler announced in September the agency's decision to "significantly curtail its reliance on the use of mammals in toxicological studies conducted to determine whether environmental contaminants have an adverse impact on human health."

The EPA plans to reduce funding for most mammal studies by 30% by 2025 and eliminate them altogether by 2035.

The agency also announced that five universities would receive $4.25 million in federal funding to develop alternatives to reduce or replace the use of animals in research.

Ostensibly, Wheeler worries about the potential mistreatment of animals used in testing. But Natural Resources Defense Council (NRDC) scientist Jennifer Sass believes he may be politically motivated.

“The Trump administration appears to be working on behalf of the chemical industry and not the public,” Sass said in an NPR interview.

Most likely, the American Chemistry Council, which represents chemical companies, would prefer to eliminate mammal studies that could prove the toxicity of their products. Wheeler, however, claims he hasn't talked to "a single chemical company about this."

According to The New York Times, the American Lung Association, the American Heart Association, and the American Medical Association disagree with Wheeler's strategy. Lab-grown cells and computer modeling can reduce the need for animal testing. But Penelope Fenner-Crisp, a former senior official at the EPA, believes 2035 may be too soon to ban all animal studies.  

"There's currently no substitute for [testing] some of the more complex and sophisticated toxicities, such as the effect of chemicals on animals' reproductive systems," she said.

The NRDC, an environmental advocacy group, also opposes the EPA's plan to ban animal testing on the grounds that it could make it harder to identify toxic chemicals and protect human health.

Animal research has played a key role in developing many new technologies, including MRIs, ultrasounds, CT scans, and new surgical techniques. It has also played an integral role in the development of vaccines, pain relievers and other medications, as well as life-saving emergency care.

“Virtually everything a doctor, nurse, veterinarian, veterinary technician, paramedic, or pharmacist can give the injured or sick was made possible by animal research," says Dr. Henry Friedman, a neuro-oncologist who leads the opposition to the EPA decision.

Dr. Friedman says sophisticated computers can be helpful in many areas of scientific research, but they "can't predict everything a new drug will do once inside you." He also maintains that laboratory animals are treated humanely under strict guidelines.

Speaking of Research, an international advocacy group that supports the use of animal research, believes the EPA's plan endangers human, animal and environmental health.

"This directive flies in the face of the EPA’s mission to 'protect human health and the environment' and 'to ensure that national efforts to reduce environmental risks are based on the best available scientific information.' Animal-based research and testing is critical for understanding how new chemicals and environmental substances affect human and non-human animals," the organization said in a statement.

Many of us in the scientific community oppose the EPA’s decision because it could slow drug development and threaten our ability to find safer and more effective treatments for pain, addiction and other diseases. If the EPA decision is sustained, it will be a major obstacle to the advancement of medical science.

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.