Insurance Claims Climb for Lyme Disease

By Pat Anson, Editor

Private insurance claims with a diagnosis of Lyme disease have soared in the U.S. over the past decade, according to a new report by FAIR Health, a nonprofit that tracks healthcare costs and insurance trends.

Lyme disease is a bacterial illness spread by ticks. It can also lead to other chronic pain conditions such as joint and back pain, chronic fatigue, fibromyalgia and neuropathy.

Fair Health analyzed a database of 23 billion private insurance claims from 2007 to 2016, and found that claims with a diagnosis of Lyme disease increased by 185 percent in rural areas and 40 percent in urban areas.

A recent CDC study also found the number of Lyme disease cases increasing, with nearly 40,000 confirmed and probable cases in 2015.

"Lyme disease is growing as a public health concern,” said FAIR Health President Robin Gelburd

Although Lyme disease historically has been concentrated in the Northeast and upper Midwest, the FAIR Health study suggests that it is spreading geographically. In 2007, insurance claims with diagnoses of Lyme disease were highest in New Jersey, Rhode Island, Connecticut, Massachusetts and New York.

By 2016, the top states were Rhode Island, New Jersey, Connecticut, North Carolina and New York -- with the emergence of North Carolina suggesting significant expansion to a new region.

Summer is the peak season for Lyme disease, with insurance claims more common in rural than in urban settings, according to the FAIR Health report. In the winter and early spring (December through April), claims involving Lyme disease were reported more often in urban than rural settings.

Age is also a differing factor in rural and urban environments. In rural settings, claims with Lyme disease diagnoses were more common for middle-aged and older people. Patients aged 41 years and older accounted for nearly two-thirds of the rural diagnoses. In urban populations, younger individuals with Lyme disease accounted for a higher percentage of claims.

Lyme disease is usually treated with antibiotics, but some patients experience complications that lead to Lyme disease syndrome (PTLDS), with long-term symptoms such as fatigue, muscle and joint pain and cognitive issues. Autoimmune diseases have also been associated with chronic Lyme disease.

Left untreated, Lyme disease can lead to serious chronic conditions, as Sarah Elizabeth Hirschle shared with us recently.

For patients with a Lyme disease diagnosis, FAIR Health reported the most common subsequent diagnoses were:

• Joint pain (dorsalgia, low back pain, hip and knee pain)
• Chronic fatigue  
• Soft tissue disorders (myalgia, neuralgia, fibromyalgia)
• Hypothyroidism

lyme disease rash

Early symptoms of Lyme disease include fever, chills, headaches, fatigue, muscle and joint aches, and swollen lymph nodes. A delayed rash often appears at the site of the tick bite. The rash grows in size and sometimes resembles a bulls-eye.

To see some tips from the CDC on how to avoid tick bites, click here.

The Four E’s That Can Help Lower Pain Levels

By Barby Ingle, Columnist

Continuing with my series on alternative pain therapies, I find it interesting that those who have not tried the treatments I cover are often the most vocal about whether they help or not. 

I want to remind readers that I am not suggesting that these are cures for any chronic pain condition, but more a way to possibly lower pain and stress levels, and increase daily activities. 

Also, please consider that pain can be bio-psycho-social in nature and may not always have a physical cause. I work with over 150 conditions in my advocacy work, and have learned that not all patients -- even with the same diseases -- respond to the same treatments. Most of the people I know that are in remission or have learned to lower or manage their pain levels are using multiple techniques and treatment options. 

The four E’s I will introduce you to are energy therapy, electromagnetic therapy, equine therapy, and exercise. 

Energy Therapy

Energy therapies, such as therapeutic touch and magnetic healing, are commonly referred to as bio-field therapies in the alternative medicine area. Supporters of these therapies believe “energy fields” flow through and around our bodies, and that when energy is flowing freely we have good emotional, physical and spiritual health. When the energy field is blocked, we become ill.

In therapeutic touch, also known as Rieke, attendants use their hands to find “blockages” and touch the patient at the blockage sites to remove the harmful energy, replacing it with their own healthy energy. In magnetic healing, the therapist places magnets at the blockage sites.

I tried an energy therapy session once and was actually in more pain when the therapist stopped than when she started.  I remained fully clothed and lay down on a massage table as the therapist moved her hands just above my body.  Because I have Reflex Sympathetic Dystrophy (RSD) and parts of my body are very sensitive, I choose the version with no touch. 

It didn’t work for me and I was told it was because the therapist didn’t follow my energy field properly. I was stressed the whole time, worried that she was going to touch me and how painful it would be. 

Energy therapy is mainly used to ease symptoms such as anxiety, fatigue, pain, nausea or vomiting. Some believe it even improves quality of life. Many people say that they feel more relaxed, calm and peaceful after an energy therapy session. I was afraid the whole time, so I didn’t get this effect. 

Some studies suggest that energy therapies work because the person experiences the focused and caring presence of a therapist, rather than a change in energy flow. More research is needed to understand the effectiveness of energy therapy, but if you are looking for a way to help lower stress and relax, this maybe a choice for you.  

Electromagnetic Therapy

Proponents of electromagnetic therapy (ET) claim that by applying low frequency electromagnetic radiation to your body that it can help lower pain levels, promote cell growth, improve blood circulation and bone repair, increase wound healing, and enhance sleep.

I tried this therapy for three months with an ET mat that I would lay on for an hour each day. The heat from the mat was relaxing and helped my circulation, but I can’t say that it worked any better than a heating blanket.

The practitioner who had me try the mat said that it could help with a wide range of symptoms and conditions, such as headaches, migraines, chronic pain, nerve disorders, spinal injuries, diabetes, arthritis, and heart disease. I think due to the increase in blood flow from the heated mat that I did get some temporary and slight pain relief.

The National Institutes of Health says there is a lack of scientific evidence about electromagnetic therapy and the American Cancer Society warns that "relying on electromagnetic treatment alone and avoiding conventional medical care may have serious health consequences." 

Equine Therapy

As the name implies, equine therapy makes use of horses (and sometimes elephants, cats, dogs and even dolphins) to help promote emotional growth. It helps to try it with an animal that can mirror human behavior. A horse is considered most effective because it can respond immediately and give feedback to the patient’s actions and behaviors.

Last year the movie "Unbridled" was released and it covered this type of therapy for physical and emotional pain. The movie is unforgettable and an uplifting story of redemption, healing, and overcoming some of life’s greatest obstacles. 

Equine therapy is usually offered for patients with attention deficit problems, anxiety, autism, dementia, delays in mental development, Downs’s syndrome, depression, trauma and brain injuries, behavior and abuse issues, and other mental health issues. 

The reason why eqine therapy has been recognized as an important area in the medical field is that some horse riders with disabilities have proven their remarkable equestrian skills in various national and international competitions. The basis of the therapy is that because horses behave similarly to humans in their social and responsive behavior, it is easier for patients to establish connection with a horse. 

I think this is an interesting concept when it comes to emotional pain. Although I haven’t done equine therapy myself, I have been intrigued over the years with the idea. That said, caring for a dog was hard for me and I can’t imagine taking care of a horse. 

Exercise

I think the word “exercise” has many different connotations for every person who hears it. Before starting any exercise program, precautions are needed to make sure you can do physical activities without further damage to your body. I have experienced unpleasant and painful exercise, which only served to make my pain worse. 

I have found that there are some exercises that are better for me than others. For instance, I can walk now for a few minutes each hour. That is more than I have done in years and I had to work my way up to it. Other pain friends can do a moderate program on stationary bicycles for 30 minutes at a time a few times a week. 

I have one friend who is doing full weight bearing activities. It causes her flares, yet she chooses to keep pushing her body until she reaches a crash. 

Please be sure to consult with a doctor before starting to exercise. Some studies suggest that moderate amounts of exercise can change your perception of pain and help you better perform activities of daily living.

It’s important to keep an open mind on what can help lower pain levels. There is no single technique or one size that fits all. From my own experience of living 20 years with chronic pain, I have explored many different options and done a fair amount of research before deciding if they were right for me to try. 

Using a multiple modality approach is often key to lowering pain levels. Nothing I have tried has been a cure, but many did help in some way.

Whether it’s one of the 4 E’s or a combination of treatments, I hope you find what helps give you a better life and that you will have continued access to it while we continue our quest for a cure.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

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

Hypnosis and Mindfulness Reduce Acute Pain

By Pat Anson, Editor

Hypnosis and mindfulness training can significantly reduce acute pain in hospital patients, according to a small study published in the Journal of General Internal Medicine.

Researchers at the University of Utah enrolled 244 hospital patients in the study who reported “intolerable pain” or “inadequate pain control” as a result of illness, disease or surgical procedures. Participants were randomly assigned to a single 15-minute session in one of three mind-body therapies: mindfulness, hypnotic suggestion or pain coping education.

All three types of intervention reduced the patients’ pain and anxiety, while increasing their feelings of relaxation.

Those who received hypnosis experienced an immediate 29 percent reduction in pain, while those who received mindfulness training had a 23 percent reduction and those who learned pain coping techniques experienced a 9 percent reduction.

Patients who received hypnosis or mindfulness training also had a significant decrease in their desire for opioid medication.

“About a third of the study participants receiving one of the two mind-body therapies achieved close to a 30 percent reduction in pain intensity,” said Eric Garland, lead author of the study and associate dean for research at the University of Utah’s College of Social Work. “This clinically significant level of pain relief is roughly equivalent to the pain relief produced by 5 milligrams of oxycodone.”

Garland’s previous research has found that multi-week mindfulness training programs can be an effective way to reduce chronic pain and decrease prescription opioid misuse. The new study added a new dimension to that work by showing that brief mind-body therapies can give immediate relief to people suffering from acute pain.

“It was really exciting and quite amazing to see such dramatic results from a single mind-body session,” said Garland. “The implications of this study are potentially huge. These brief mind-body therapies could be cost-effectively and feasibly integrated into standard medical care as useful adjuncts to pain management.”

Garland and his research team are planning a larger, national study of mind-body therapies that involve thousands of patients in hospitals around the country. Garland was recently named as director of the university’s new Center on Mindfulness and Integrative Health Intervention Development. The center will assume oversight of more than $17 million in federal research grants.

Many chronic pain patients are skeptical of mindfulness, cognitive behavioral therapy (CT) and other mind-body therapies, but there is evidence they work for some.

A recent study found that CBT lessened pain and improved function better than standard treatments for low back pain. Another study at Wake Forest University found that mindfulness meditation appears to activate parts of the brain associated with pain control.

You can experience a free 20-minute online meditation program designed to reduce pain and anxiety by visiting Meditainment.com.

The Myth of the Opioid Addicted Chronic Pain Patient

By Roger Chriss, Columnist

Prescription opioid use for chronic pain does not usually lead to addiction or to the use of illicit opioids such as heroin. But media reports often say otherwise.

“Opioids can be so addictive that many people develop a desperate need for them even after the pain has subsided, or disappeared. So when they’re turned away by doctors and pharmacies, they look for a fix on the streets,” Fox News recently reported.

Public officials also confuse the issue.

“Most of our constituents with substance-use disorders began their path to addiction after forming dependencies to opioids prescribed as a result of an injury or other medical issue,’ Anne Arundel County Executive Steve Schuh wrote in a letter to Maryland doctors. ‘Their opioid dependence may have led to obtaining illegal street opioids like heroin, sometimes laced with fentanyl, after valid prescriptions ran out.’”

But this is not what usually happens.

“What the media has sometimes missed is that of those people who started with prescription opioids and then went on to use heroin, 75% never had a legal prescription for opioids. They were already stealing or buying the drugs illegally,” Judith Paice, PhD, RN, director of the Cancer Pain Program at Northwestern University told Medscape.

In other words, the reality of opioid therapy for chronic painful conditions is quite different from what media coverage and public officials claim.

In fact, the majority of chronic pain patients never even receive opioid medications. Recent estimates state that between 8 and 11 million chronic pain patients receive an opioid prescription at some point in a given year, with only some of them taking opioids for pain control on a daily basis.

Although that is a large number, it is dwarfed by the National Institutes of Health’s estimate that 25.3 million Americans live with daily chronic pain and nearly 40 million have severe pain. That  includes people in hospice and other end-of-life care, as well as people enduring cancer pain.

Moreover, many of the chronic pain patients who receive daily opioid therapy get there only after having failed many other treatment options, including non-opioid drugs and physical therapy. Opioids are rarely the first choice for treating persistent pain conditions, especially in the wake of opioid prescribing guidelines from the CDC, Department of Veterans Affairs, and some states.

Chronic pain patients are carefully screened, scrutinized, and monitored. They are subjected to risk assessment using the Opioid Risk Tool, required to take urine and saliva drug tests, told to show their prescription bottles and have their pills counted, and given pain contracts to sign. Their prescriptions are verified at pharmacies and tracked through prescription drug monitoring programs. Opioid misuse in any form is readily detected and is far from common.

Therefore, it is a myth that opioid addiction or other forms of opioid use disorder starts with a prescription. Instead, it almost always begins at a young age with the misuse of other drugs, such as tobacco, alcohol and marijuana. About 90% of drug addiction starts during adolescence.

And although most people who are addicted to heroin have previously used prescription opioids, the opposite is not true. Most people on opioid therapy do not become addicted to prescription opioids, and most of the people who do become addicted do not transition to heroin.

But the myth confuses and conflates chronic pain and opioid addiction. And this is having real-world consequences, both for people on opioid therapy for chronic pain and for people with opioid use disorder.

For people on opioid therapy, the problems include forced medication tapers or even termination of therapy. Pain management is an essential part of a variety of diseases and disorders, from the neuropathy of arachnoiditis and multiple sclerosis, to the visceral pain of interstitial cystitis and porphyria, to the musculoskeletal pain of Ehlers-Danlos syndrome. The choice and dose of medication should be a clinical decision made between patient and physician, not a blanket determination made by a guideline, regulation or committee.

Further, chronic pain is fast becoming undertreated or even untreated, which can have major health consequences. Forcing people to live without good pain management only creates more medical problems. 

For people suffering from opioid use disorder, the addiction myth embodies the idea that it is just accidental chemistry. But as Maia Szalavitz explains in her book Unbroken Brain, addiction has three key components: “The behavior has a psychological purpose; the specific learning pathways involved make it become nearly automatic and compulsive; and it doesn’t stop when it is no longer adaptive.”

The perpetuation of this myth has resulted in people not getting effective care, because the focus is on the substance instead of the sufferer.

“If we don’t invest in people and we focus on drugs, we end up creating another polarizing conversation about substances and people will continue to fall through the cracks,” Dr. Joseph Lee of the Hazelden-Betty Ford Foundation told the Minnesota Post.

The myth of the opioid-addicted chronic pain patient needs to be banished before it causes more people to fall through the cracks.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

6 Reasons Opioids Get More Attention Than Alcohol

By Janice Reynolds, Guest Columnist

Every day we hear how the “opioid crisis” is spiraling out of control.  Some even claim it is the worst health crisis to ever hit our country.  The response has largely been to restrict access to opioid pain medications and to sue the pharmaceutical companies that produce them.

But what is the real crisis? The elephant in the room that everyone conveniently ignores?

I believe opioids are being used to cover-up and distract from the real addiction crisis, which is alcohol abuse. 

Alcoholic beverages have been with us for thousands of years and are an important part of everyday life. Alcohol consumption has been increasing in the U.S. since the late 1990's and today about 57 percent of Americans drink alcohol at least once monthly, far more than consume opioids. Drinking to excess is usually frowned upon, but has long been treated as socially acceptable, even by the Puritans:

Drink is in itself a good creature of God, and to be received with thankfulness, but the abuse of drink is from Satan, the wine is from God, but the Drunkard is from the Devil.                                                                                                                                                        --  Increase Mather, Puritan clergyman in “Wo to Drunkards” (1673)

Alcohol is the fourth leading cause of preventable death in the in the United States. In 2015, over 30,000 Americans died directly from alcohol induced cases, such as alcohol poisoning and cirrhosis of the liver. 

There are another 88,000 deaths annually from alcohol related causes, including motor vehicle accidents, homicide, suicide, and incidents of poor judgement – such as going out in subzero weather and freezing to death, and infants dying after being left in hot cars by drunk fathers.

Many harms also occur that usually do not result in death, such as alcohol-related sexual assault or date rape, fetal alcohol syndrome, and fetal alcohol spectrum disorders. The World Health Organization reports that alcohol contributes to more than 200 diseases and injury-related health conditions, including alcohol dependence, cirrhosis, cancers, and injuries.

So why is alcohol ignored and the so-called opioid epidemic is hyped? Here are six reasons:

1) Many people drink alcohol. They may only drink “socially” and need a glass of wine or beer to relax, enjoy a sporting event or socialize at a party. Alcoholic beverages are an integral part of mealtime for many people.   

We also have functional alcoholics who are secret addicts.  As a nurse for over 20 years, it was not uncommon for me to have a patient begin to go through withdrawal after 48 hours in the hospital. Usually they deny drinking alcohol or admit to one drink a night. There is also denial by the medical profession about the dangers posed by alcohol, such as addiction specialists who differentiate between heavy drinkers and alcoholics.

Research frequently ignores alcohol entirely. A recent study looked at health conditions linked to Alzheimer’s disease and mentioned obesity, high blood pressure, diabetes and depression. Alcohol was not even considered, even though it has been shown in valid studies to damage brain cells.

2) Alcohol is BIG business.  Profits are immense and generate tax revenue.  Profits for breweries, distilleries and related businesses far outstrip what pharmaceutical companies make from opioids.  We see these monies going not only to shareholders, but government, lobbyists and advertising.

No one complains about a full-page newspaper ad for a brand of vodka, but a commercial during the Super Bowl for medication to treat opioid induced constipation sparks outrage. And no one bats an eye when a story about Maine liquor stores dropping the price of hard liquor is on the same front page with another article on the opioid crisis.

When have you ever seen a stadium named after an opioid or even a pharmaceutical company? Yet we have Coors Field in Denver, Busch Stadium in Saint Louis, and Miller Park in Milwaukee.

3) Problems need scapegoats. In this case we have two scapegoats: people in pain and opioids.  

Prejudices against people in pain have long existed: “It’s all in your head” or “the pain can’t be that bad” are all too familiar. It could also be simple bigotry towards someone different or a lack of compassion. We used to call pain management “an art and a science,” now it is optional and politically driven medicine.

Opiophobia has a long history as well; fear of addiction, fear of respiratory depression, belief that opioids don’t work, and that people in pain are drug seekers. The “opioid epidemic” has opened the gateway for uncontrollable and irrational bigots.

Nearly all the interventions to curb drug overdoses have been directed at people in pain, who are not responsible for the illegal use of opioids. If all prescription opioids disappeared tomorrow, it would have nil effect on the opioid crisis. Addicts would just turn to heroin and illegal fentanyl (if they haven’t already). There are a boatload of ways to get high.

4) McCarthyism: In the 1950’s, Senator Joseph McCarthy went hunting for communists and many lives were ruined. Today, the term “McCarthyism” defines a campaign or practice that uses unfair and reckless allegations, as well as guilt by association. 

Politicians, the media and many doctors are afraid to say anything not endorsing the “opioid epidemic” or supporting people in pain, because it will be held against them.

5) Fear-mongering:  The spread of frightening and exaggerated rumors of an impending danger that purposely and needlessly arouses public fear.

We can see this in the psychological manipulation that uses scare tactics, exaggeration and repetition to influence public attitudes about opioids. This is exactly what Andrew Kolodny and Physicians for Responsible Opioid Prescribing (PROP) are doing, along with formally reputable organizations such as the Food and Drug Administration and professional medical associations.

6) The alphabet soup: The CDC, DEA, and the bureau of Alcohol, Tobacco and Firearms (ATF) have all played a part in distracting us from alcohol abuse.  Although it is a drug, alcohol is not usually covered by the DEA, but is handled by the ATF, which mainly concerns itself with alcohol licensing and collecting alcohol taxes.

The DEA has been totally helpless to stop the influx of illegal opioids like heroin and illicit fentanyl, as well as thediversion of prescription medications. Their survival mechanism is to go after the legitimate use of opioids for pain.  They have become a terrorist organization that is driving providers out of pain management.

In order to cover-up the heavy cost of alcohol abuse, we have seen hysteria driven by politicians and the media. This has resulted in difficulty getting opioids prescribed for pain, skewered facts to support the “opioid epidemic,” the CDC’s opioid guidelines, and what I call the passive genocide of people in pain.

There are many different means by which genocide can be achieved and not all have to be active (murder or deportation). For our usage, genocide means “the promotion and execution of policies by a state or its agents which result in the deaths (real and figuratively) of a substantial portion of a group.” 

Our genocide is passive because it relies on the harmful effects of pain, suicide, withdrawal of treatment, excessive use of over-the-counter pain relievers, malpractice, and the total dismissal of the human rights of people with pain; as well as lies and falsehoods being held as truths to promote this genocide.

This is not to say that alcohol should be made illegal. Prohibition did not work because most people wanted alcohol and it lead to a huge criminal enterprise. It is to say prescription opioids should not be treated differently than other medications or alcohol.  And people in pain should not be used to further an agenda based on fallacious, unethical and immoral sensationalism. 

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including a regular one on cooking with pain. 

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

Is It Safe to Use Cannabis with THC?

By Ellen Lenox Smith, Columnist

I am constantly reading about people interested in medical marijuana who are seeking information on cannabis products high in CBD for their medical issues.  I’ve also noticed many stating they do not want any THC in these products.

I’ve found that I need both. 

Tetrahydrocannabinol (THC) and cannabidiol (CBD) are chemical compounds, called cannabinoids, found in the marijuana plant. There are well over a hundred different cannabinoids in marijuana, and they all interact with receptors in the brain and body, causing various effects.

THC is the most widely known cannabinoid, due to its abundance and psychoactive qualities. For centuries, marijuana has been used recreationally because of THC’s ability to make people feel “high” or euphoric.

But as cannabis has become more accepted for medical use, some are concerned that they will get high or stoned if their cannabis has any THC in it. Many have turned to cannabis products that primarily contain CBD. 

Personally, I have learned to look for products that contain both THC and CBD, as they are more effective in easing my pain and helping me sleep.

DRUG POLICY ALLIANCE

Personally, I have learned to look for products that contain both THC and CBD, as they are more effective in easing my pain and helping me sleep.

Many patients became interested in CBD after learning that epileptic seizures could be reduced or even stopped by utilizing cannabis products high in CBD content.  This was discovered when the parents of Charlotte Figi, a 5-year old girl suffering from severe seizures, learned of a cannabis strain that was loaded with CBD. This was what they wanted to try with their daughter, because it was completely non-psychoactive, unlike THC. The results were amazing, not only reducing Charlotte’s seizures, but also opening up the possibility of helping patients with other conditions such as spasms, anxiety and chronic pain.

Like me, many patients with chronic conditions have found that they need to use medical cannabis extracted from either a high CBD variety or one with more THC. If you find a high-CBD strain, it does not mean it will be THC-free. Many strains advertised as “high-CBD” still contain some psychoactive cannabinoids. This should not scare you.

I am 67 years old and have been using cannabis since 2007 for two incurable painful conditions.   Like many patients, I had no desire to experience the psychoactive effects of THC, so at one point in my treatment I tried a high CBD strain containing only trace amounts of THC. The pain relief just didn’t happen, so I switched back to cannabis products that combined CBD and THC.

Recently, after reading that CBD can help with cancer, lupus, nicotine addiction, Parkinson’s disease, osteoporosis and other chronic conditions, I decided to grow plants high in CBD to add to the oil I take orally at night. I now make an oil with a combination of strains that include this higher CBD strain, along with higher THC plants.

I want you to know that I do not get “high” or stoned, as some assume. What I get is pain relief.

But remember, as with any medication, you can take too much and get a negative reaction, so be careful to take the dose that is right for you. Don’t be concerned if you are like me and need THC to get relief from your pain. Each body requires something different and we all need to find the correct match for safe relief.

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their website.

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

Pain Patients Need to Stop Demonizing Addicts

By Crystal Lindell, Columnist

Ok. Wait. Before you read the headline and send me hate mail, I just want to remind you guys that I am a pain patient. Just like you. So take a breath and let me explain.

So yes, the pain patient community needs to stop demonizing “addicts.” I know. I know. They make a great enemy. I mean, if it wasn’t for all those opioid addicts out there, we’d all be able to get the medications we need. Am I right?

But just as pain is complicated, so is addiction and so are opioids.

I recently wrote a column about my first time getting a lidocaine infusion, and it included a throwaway line about how I was hoping the treatment will help me get off opioids because, “I don’t actually love being high all the time.”

Dang. People were not happy I said that.

Apparently, there is this idea out there that if you are taking opioids like hydrocodone for legitimate physical pain, then you don’t get high from the medications. And if you are getting a high from them, then you’re an addict. The end.

Unfortunately, that’s not exactly how opioids work. There is no magic pill (yet) that we can take that relieves physical pain without also impacting our brains.  

Part of the problem that people seem to have a very specific idea about what the word “high” means. There’s a common trop in pop culture that shows addicts in tattered clothes, lying in an alley with their eyes rolled back in their heads. But that is far from the full picture.

When I take a hydrocodone, even a very small dose of 2.5 mg, I get more relaxed, a little tired, and my reactions are delayed. That’s also a version of getting high. And pretty much everyone else on even a low dose of opioids is likely having the same reaction.

Personally, I have found that when the drugs don’t have that impact on you, it usually means your body is getting used to them, and it will be that much harder to quit taking them.

Look, I get it. The current mood of the country is that opioids are evil and must be stopped. And for people suffering from horrific chronic pain, losing what is often the only treatment that actually works is horrifying. It’s easy to just point to the people causing all the opioid hysteria (the addicts) and blame them. But it’s more complicated than that.

Because when a Ohio sheriff refuses to carry the opioid overdose medication Narcan, it doesn’t just hurt addicts. It hurts pain patients who may accidentally overdose too.

And when addicts start out taking these drugs because of physical pain, what right do we have to attack them? We started taking them for the exact same reason.

I know that many pain patients find great comfort in separating the idea of addiction and physical dependence, but I have to tell you something that I learned when I took myself off morphine — the two aren’t actually all that different.

When you are on 60 mg of opioids a day for years at a time like I was and then stop taking them, your body doesn’t care why you started in the first place. And even if you can get through the first week of hellish withdrawal with horrible flu symptoms, panic attacks, insomnia and diarrhea, your brain could still crave the drug for as long as two years. It got used to having opioids, and has to rewire itself to function without it.

Pain patients often take opioids hoping it will alleviate their symptoms and make them feel normal again. But guess what? Addicts take them for the same reason. At a certain point, they need the drugs just to feel normal because their brain doesn’t work right without them anymore.

And, while pain patients start taking opioids for physical pain, many addicts usually started taking them to relieve pain as well — it’s just that their pain is emotional. But anyone who has ever suffered through a truly tragic loss or heartbreak can tell you that emotional pain can be just as awful as any physical pain. We all just want to feel better.

What Can We Do?

I truly believe that the government should not be involved in our health care decisions and I’m against many of the new regulations that try to limit what doctors can prescribe. Whether or not you should take opioids is a decision that should be made solely between you and your doctor. And I know that the reason many people take opioids is because there are no other effective treatment options available.

However, pretending that pain patients somehow have a different response to these medications than anyone else is naïve. And the sooner we recognize how intense the drugs are, the sooner we can actually start looking at realistic ways to help pain patients as well as addicts.

So how can we move forward? Well, legalizing marijuana everywhere would be a good first step, but even that won’t help everyone. We also need more research into pain treatments that actually work as realistic alternatives to opioids. We also must approach addiction with the same compassion we usually reserve for physical health problems. Addiction is a mental health issue, and the key word there is health.

We need to take a hard look at how we treat addiction, and move into longer-term models that help people for years and include professional psychiatric help. Pretending someone can get over opioid withdrawal by solely going to Narcotic Anonymous meetings is like pretending someone can get over cancer by solely going to weekly support group meetings.

We also need to treat underlying mental health issues like the serious health problems they are, because when people get their clinical anxiety and depression treated correctly, they are less likely to try to self-medicate with drugs like opioids.

Perhaps the best thing pain patients can do is join the same team as the addicts we love to hate. Because if fewer people were abusing opioids, then maybe the government would stop trying to take them away from pain patients.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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

PROP Founder Calls for Forced Opioid Tapering

By Pat Anson, Editor

Have you or a loved one been harmed by being tapered off high doses of opioid pain medication?

The founder of an anti-opioid activist group wants to know – or at least he posed the question during a debate about opioid tapering with colleagues on Twitter this week.

“Outside of palliative care, dangerously high doses should be reduced even if patient refuses.  Where exactly is this done in a risky way?” wrote Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP). 

“I’m asking you to point to a specific clinic or health system that is forcing tapers in a risky fashion. Where is this happening?”

It’s not an idle question. About 10 million Americans take opioid medication daily for chronic pain, and many are being weaned or tapered to lower doses -- some willingly, some not -- because of fears that high doses can lead to addiction and overdose.

Kolodny’s Twitter posts were triggered by recent research published in the Annals of Internal Medicine that evaluated 67 studies on the safety and effectiveness of opioid tapering. Most of those studies were considered very poor quality.

“Although confidence is limited by the very low quality of evidence overall, findings from this systematic review suggest that pain, function, and quality of life may improve during and after opioid dose reduction,” wrote co-author Erin Krebs, MD, of the Minneapolis Veterans Affairs Health Care System. 

Krebs was an original member of the “Core Expert Group” – an advisory panel that secretly helped draft the CDC opioid prescribing guidelines with a good deal of input from PROP. She also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Curiously, while Krebs and her colleagues were willing to accept poor quality evidence about the benefits of tapering, they were not as eager to accept poor evidence of the risks associated with tapering. 

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms,” wrote Krebs.

But the risk of suicide is not be taken lightly, as we learned in the case of Bryan Spece, a 54-year old chronic pain sufferer who shot himself to death a few weeks after his high oxycodone dose was abruptly reduced by 70 percent.  Hundreds of other pain sufferers at the Montana clinic where Spece was a patient have also seen their doses cut or stopped entirely.

Spece’s suicide was not an isolated incident, as we are often reminded by PNN readers.

“A 38 year old young lady here took a gun and put a bullet in her head after being abruptly cut off of her pain medication,” Helen wrote to us. “Her whole life ahead of her. This is happening every day, it just isn't being reported.”

“I too recently lost a friend who took his own life due to the fact that he was in constant pain and the clinic he was going to cut him off completely,” said Tony.

“I have been made to detox on my own as doctors who were not comfortable giving out these meds would take me off, not wean me,” wrote Brian. “Was a nightmare. Thought I was gonna die. No, I wanted to die.”

“In the end when you realize that you’re not going to get help and that you have nothing left, suicide is all you have,” wrote Justin, who is disabled by pain and no longer able to work or pay his bills after being taken off opioids. “I don't want to hurt my family. I don't want to die. However it is the only way out now. I just hope my family and the good Lord can forgive me.”

Patient advocates like Terri Lewis, PhD, say it is reckless to abruptly taper anyone off high doses of opioids or to aim for artificial goals such as a particular dose. She says every patient is different.

“There is plenty of evidence that persons treated with opiates have variable responses - some achieve no benefit at all.  Some require very little, others require larger doses to achieve the same benefit,” Lewis wrote in an email to PNN.

“It is an over-generalization to claim that opiates are lousy drugs for chronic pain. Chronic pain is generated from more than 200 medical conditions, each of which generate differing patterns of illness and pain generation. For some, it may be reflective of its own unique disease process. We have to retain the ability to treat the person, not the label, not to the dose.”

Patient ‘Buy-in’ Important for Successful Tapering

And what about Kolodny’s contention that high opioid doses should be reduced even if a patient refuses? Not a good idea, according to a top CDC official, who says patient “buy-in” and collaboration is important if tapering is to be successful.

“Neither (Kreb’s) review nor CDC's guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial in the Annals of Internal Medicine.  “Clinicians have a responsibility to carefully manage opioid therapy and not abandon patients in chronic pain. Obtaining patient buy-in before tapering is a critical and not insurmountable task.”

The CDC guideline also stresses that tapering should be done slowly and with patient input.

“For patients who agree to taper opioids to lower dosages, clinicians should collaborate with the patient on a tapering plan,” the guideline states. “Experts noted that patients tapering opioids after taking them for years might require very slow opioid tapers as well as pauses in the taper to allow gradual accommodation to lower opioid dosages.”

The CDC recommends a "go slow" approach and individualized treatment when patients are tapered.  A "reasonable starting point" would be 10% of the original dose per week, according to the CDC, and patients who have been on opioids for a long time should have even slower tapers of 10% a month.

The Department of Veterans Affairs takes a more aggressive approach to tapering, recommending tapers of 5% to 20% every four weeks, although in some high dose cases the VA says an initial rapid taper of 20% to 50% a day is needed. If a veteran resists tapering, VA doctors are advised to request mental health support and consider the possibility that the patient has an opioid use disorder.

Have you been tapered at a level faster than what the CDC and VA recommend? Let us know by leaving a comment below.

If you think you were tapered in a risky way, you can let Dr. Kolodny know at his Twitter address: @andrewkolodny.

The Case for Opioid Therapy

By Jordan LaMark, Guest Columnist

I take opioid pain medication and I am not ashamed of it. I refuse to feel guilty for needing medication.

I am not an addict. I do not deserve to be treated like a criminal – and for that matter, neither do addicts. I should not have to jump through hoops, be subjected to intense scrutiny, and constantly be forced to prove how much pain I’m in to receive my medication. It shouldn’t be a battle to receive treatment.

I live with Ehlers Danlos syndrome, a chronic incurable condition that causes daily unceasing pain. The pain wears at me, saps my energy, and severely restricts my functionality.

I also battle many other symptoms -- chronic fatigue, nausea, dysfunction of my autonomic nervous system, and failure of my digestive tract that requires me to be fed by a surgically implanted feeding tube (which is also very painful, and has altered my core muscles and posture). I sometimes need a wheelchair to get around and often cannot leave the house for days.

I spend most of my time dealing with my medical conditions. My pain medication gives me some relief and improves my functionality without negative side effects. I also use many other techniques to deal with my pain, including several forms of therapy, and I’ve had two surgeries to treat severe endometriosis.

Despite all of this, I am a happy person and do as much as I physically can, spending time with my family, going to church and daytime events, even the beach. Now, however, I am afraid that there may come a point when I may be unable to obtain the medication that improves my quality of life.

JORDAN LAMARK

There is no doubt an opioid abuse problem in our nation. However, the answer is not to enact reactionary laws and restrictions that make it harder for patients with a legitimate need to receive their medication. The conversation about opioids has been focused on acute patients and those who have had surgery or an injury, but has neglected to mention the unintended victims of anti-opioid campaigns: chronic pain patients who will most likely need medication for the rest of their lives.

Neglected also is that most of the abuse of prescription opioids takes place outside of the doctor-patient relationship. The World Health Organization tells us the risk of dependence and diversion is low when opioids are prescribed for pain. Studies also show that physician prescribed opioids are not the primary source of diversion and that theft from the drug distribution chain is an important source of illicit pain medication.

The CDC, along with other organizations and federal and state governments, has overstepped its authority by releasing a set of guidelines for opioid prescribing. Although the guidelines do not prohibit the prescription of opioids, they have increased the complexity and effort involved in getting them. This has had the same effect as declaring them illegal. Most doctors that I’ve talked to flatly state that they don’t prescribe opioids anymore.

I recently saw a pain doctor at one of the best hospitals in the country and was told that their policy is to not prescribe opioids to non-cancer patients. When asked what I should do, since in my case other methods either have not worked or cannot be used due to side effects, the doctor said he did not have a suggestion and wished he could prescribe them for me, but was unable to.

Many patients are having their dosages reduced in response to the CDC guidelines, and some are left with the heart-wrenching prospect of having their medication completely cut off. Many are now being forced to undergo monthly drug tests in order to receive treatment, even when there is no reason to suspect abuse. Our criminal justice system treats suspects as “innocent until proven guilty,” but the same logic does not seem to apply in this case.

I have personally had a pharmacist at a major chain refuse to fill my prescription and lie about the reason why, and then make negative comments about it to my face. I have had several doctors express concerns about legal action and increased government interference in opioid prescription, and cite these as reasons for not prescribing.

One pain specialist gave me several reasons that doctors are now hesitant to prescribe opioids. Number one, of course, was public and government pressure, followed by the increased complexity of prescribing and the fear of losing his license.

Another reason cited was the lack of an “equation” to tell doctors what and how much to prescribe. I think that is a faulty argument. Psychiatric drugs, for example, do not have such an equation or rubric --that is left up to the doctor’s discretion, as it should be.

I have been denied coverage for a treatment because my condition was not on my insurance company’s list of those approved to receive the treatment. Someone who had never met me decided he or she knew better than my doctor (and I) what potentially life-saving treatment I could receive.

Doctors often suggest “alternative treatments” such as cognitive behavioral therapy, which is usually not covered by insurance; acupuncture, which is almost never covered; and physical therapy, which becomes very expensive even with insurance if you are going several times a week for months. Medical marijuana is not covered and is prohibitively expensive. These alternative therapies, while worth trying, do not help everyone.  ­

If the medical industry and government are really serious about promoting alternative, non-opioid therapies, then they should be made affordable. Continuing to say “opioids are bad” and promoting restrictive laws does not stop illicit drug use and only hurts those who need them. These decisions should not be made by insurance companies or the government, they should be up to the individual physician and patient.

I have a feeding tube that was surgically placed and has forever altered my body. I have an open wound that causes pain and infections. The surgery carried risk, the act of changing the tube every few months carries a risk, and the tube’s mere presence is a risk. And yet, it’s all worth the risk because it keeps me alive. My pain medication takes the life that the tube has saved and makes it a life worth saving.

The medical industry does not have to bow to public or political pressure. This is the time for doctors and patients to stand up and reject reactionary responses. Do not take away the only relief many of us have.

Jordan LaMark lives with Ehlers-Danlos Syndrome and comorbid conditions, including Mast Cell Activation Syndrome (MCAS) and gastroparesis, for which she has a permanent feeding tube.

Jordan is the founder of Digesting that Facts, a website about living with her various medical conditions that includes educational information and research articles.

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

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

Safeway Fined $3 Million for Painkiller Thefts

By Pat Anson, Editor

Safeway has agreed to pay a $3 million fine to settle allegations that it failed to timely report the theft of tens of thousands of hydrocodone tablets from pharmacies in Alaska and Washington state. The company also agreed to a compliance agreement with the Drug Enforcement Administration to ensure such lapses do not happen again.

The DEA learned of the hydrocodone thefts at Safeway pharmacies in North Bend, Washington and Wasilla, Alaska in April 2014, months after Safeway discovered the pills were stolen by employees. Under federal law, pharmacies are required to notify the DEA of the theft or significant loss of any controlled substance within one business day of the discovery of the theft or loss.

A DEA investigation of the case was later widened to review practices at all Safeway pharmacies nationwide between 2009 and 2014.  The investigation revealed a “widespread practice” of Safeway pharmacies failing to timely report missing or stolen controlled substances. 

“At this crucial juncture in our efforts to combat abuses of prescription drugs, it is imperative that pharmacies notify DEA immediately when drugs are stolen or missing.  A quick response to such reports is one of the best tools DEA has in stopping prescription drug diversion,” said DEA Special Agent in Charge Keith Weis.

As part of the settlement, Safeway will close a pharmacy in Belmont, CA and will suspend filling prescriptions for controlled substances for four months at a pharmacy in North Bend, WA.

“Safeway cooperated fully with government investigators throughout the investigation and remains an active partner with the DEA, local law enforcement and the communities it serves in the fight against prescription drug abuse, including the abuse of opioids,” the company said in a statement.  “Since early 2015, the Company has significantly enhanced its controlled substance monitoring program and implemented a variety of improved policies and procedures to enforce compliance with the Controlled Substances Act.”

Safeway is the latest in a string of pharmacy operators that have been fined for failing to comply with the Controlled Substances Act.

Last week CVS Health Corp agreed pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone. In January, Costco paid nearly $12 million to settle allegations that its pharmacies filled invalid prescriptions and failed to maintain accurate records at two central fill locations in Sacramento, California and Everett, Washington.

“We call on all participants in drug distribution to carefully monitor their practices to stem the flow of narcotics to those who should not have them,” said U.S. Attorney Annette L. Hayes.  “Pharmacies have a key role to play in making sure only those with legitimate prescriptions receive these powerful and potentially addictive drugs, including by timely reporting losses of those drugs.  Failure to do so hamstrings DEA’s investigative abilities and frustrates some of our best methods at curbing abuse.” 

New Opioid Painkiller Has Less Abuse Potential

By Pat Anson, Editor

A new opioid medication being developed by Nektar Therapeutics for the treatment of moderate to severe chronic pain has significantly less abuse potential than oxycodone -- even at high doses – according to the results of a new clinical study.

The investigational oral drug – known as NKTR-181 -- is the first analgesic opioid designed to reduce side effects such as euphoria, which can lead to abuse and addiction.

In a small study involving 54 recreational drug users, NKTR-181 had significantly less “drug liking” than oxycodone in the first hours of use. The dosage given to the study participants ranged from a maximum therapeutic dose of 400mg of NKTR-181 to a “supratherapeutic” dose that was 3 to 12 times higher than common doses of oxycodone.

"It is clear from our new study results that NKTR-181 is highly differentiated in this respect from oxycodone, which is a choice drug of abuse.  Further, and critically important in the context of this public health emergency, NKTR-181's less rewarding properties and strong analgesia are inherent to its novel molecular structure and independent of any abuse-deterrent formulation,” said Ivan Gergel, MD, Senior Vice President and Chief Medical Officer of Nektar. 

“Many patients do not receive adequate pain relief because they fear taking conventional opioids, including abuse-deterrent formulations, because of their potential for abuse and addiction.  We believe NKTR-181 is a transformational pain medicine that should significantly advance the treatment of chronic pain and could be a fundamental building block in the fight against prescription opioid abuse.”

nektar therapeutics

In March, NKTR-181 received “fast track” designation from the Food and Drug Administration -- a status that allows for an expedited review of the drug – after Nektar reported positive results from a Phase 3 study of over 600 patients with chronic back pain.  Pain scores dropped by an average of 65% in patients taking NKTR-181 twice daily.

The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier, which slows its rate of entry into the brain – thus reducing the “high” or euphoric effect. Many pain sufferers say they do not get high or experience euphoria from opioid medication, but drug makers and regulators are working to develop painkillers with less risk of abuse and addiction.  

"Getting very high, very fast, is a mark of conventional high-risk, abused opioids," said Jack Henningfield, PhD, vice president at Pinney Associates and adjunct professor at The Johns Hopkins University School of Medicine. "NKTR-181 represents a meaningful advance in the treatment of pain as the first opioid analgesic with inherent brain-entry kinetics that avoids this addictive quality of traditional opioids. This prevents the rapid 'rush' that abusers seek during the critical period immediately after dosing. Importantly, these properties of NKTR-181 are inherent to its molecular structure and are not changed through tampering or route of administration." 

Because NKTR-181 produces less euphoria, Nektar believes it should be scheduled as a Class III or Class IV controlled substance, a less restrictive schedule than Class II medications, a category that includes oxycodone, hydrocodone and many other opioids.

Nektar is a research-based biopharmaceutical company that discovers and develops new drugs for which there is a high unmet medical need. It has a pipeline of new investigational drugs to treat cancer, auto-immune disease and chronic pain.

Lessons from Dreamland About the Opioid Crisis

By Roger Chriss, Columnist

The book Dreamland: The True Tale of America's Opiate Epidemic by Sam Quinones has become a playbook for many lawmakers, regulators and journalists covering the opioid crisis. It is an award-winning book from 2015 that describes the rise of Mexican “black tar” heroin, pill mills and opioid addiction starting in the 1980’s.

It is not a book about persistent pain disorders or the people who endure them using opioid medications.

Quinones interviews heroin couriers and addicts, as well as prescription opioid addicts. He describes heroin smuggling, heroin distribution networks, prescription opioid diversion, carefully crafted medical opioid scams, and misleading marketing by opioid manufacturers. But chronic pain patients do not appear in Dreamland at all.

Early in the book, Quinones brings up a 1980 research letter in The New England Journal of Medicine and the work of Russell Portnoy, both of which are alleged to have contributed to opioid overprescribing. But the overprescribing does not involve people with chronic pain disorders. Instead, Quinones explains that “in the Rust Belt, another kind of pain had emerged. Waves of people sought disability as a way to survive as jobs departed.”

And overprescribing did not necessarily mean over-consumption. As Quinones states, “Seniors realized they could subsidize their retirement by selling their prescription Oxys to younger folks. Some of the first Oxy dealers, in fact, were seniors who saw the value of the pills in their cabinets.”

Such opportunities were not ignored. More conventional drug dealers moved in and unscrupulous physicians opened drug-dealing clinics that we now call pill mills.

Quinones explains how to recognize a pill mill: “I asked a detective, seasoned by investigations into many of these clinics, to describe the difference between a pill mill and a legitimate pain clinic. Look at the parking lot, he said. If you see lines of people standing around outside, smoking, people getting pizza delivered, fistfights, and traffic jams—if you see people in pajamas who don’t care what they look like in public, that’s a pill mill.”

The importance of pill mills to the opioid crisis cannot be understated.

“It helps that OxyContin came in 40 and 80 mg pills, and generic oxycodone came in 10, 15, 20, and 30 mg doses—different denominations for ease of use as currency. The pill mills acted as the central banks, controlling the ‘money supply,’ which they kept constant and plentiful, and thus resisted inflationary or deflationary spikes,” wrote Quinones.

Dreamland goes on to explain that in rural Appalachian communities an underground economy arose with prescription opioids as currency, supported by scamming Medicaid and Social Security disability. Some addicts funded their habit by shoplifting at stores like Walmart and paying dealers for opioid pills with their stolen goods. Other addicts worked with dealers to scam Medicaid to pay for opioids from pill mills or to get opioids from legitimate clinics using forged medical records.

Opioid addiction was also driven by high school and college sports. Quinones explains that “after the games, some of the trainers pulled out a large jar and handed out oxycodone and hydrocodone pills - as many as a dozen to each player. Later in the week, a doctor would write players prescriptions for opiate painkillers, and send student aides to the pharmacy to fill them.”

Thus, the opioid crisis is a tragic result of a confluence of forces, including heroin sold under a business model virtually impervious to traditional law enforcement techniques and legal opioid pills used illicitly. As Quinones explains at the end of the book, “One way to view what happened was as some enormous social experiment to see how many Americans had the propensity for addiction.”

None of this involves medical opioids being used for pain management in people with chronic, progressive, or degenerative disorders. Quinones frequently mentions “chronic pain” but never defines the term precisely. However, his examples consistently refer to ongoing pain from a workplace accident, sports injury or accidental trauma -- not the persistent pain of a medical disorder. He does not interview pain management specialists or chronic pain patients because that is not the point of the book.

However, he does acknowledge the opioid crisis is having an unintended effect on people with persistent pain disorders. Quoting Quinones, “Patients who truly needed low-dose opiate treatment for their pain were having difficulty finding anyone to prescribe it.”

That is the lesson that Dreamland offers but too few people are learning. The opioid crisis is a dire manifestation of a larger problem of substance abuse. It is not about people with chronic pain disorders becoming addicted to opioids and then turning to heroin, an outcome that is exceedingly rare.

If we don’t understand what this book offers, we risk making the same mistakes that many lawmakers, regulators and journalists keep making. We’ll misunderstand the true nature of the opioid crisis and mismanage the response. And that will harm both opioid addicts and chronic pain patients, two groups that have already suffered enough.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

The Importance of Understanding Research

By Janice Reynolds, Guest Columnist

Almost daily we are told that a study shows this or research shows that, a physician makes claims based on research, or the news media blaring “New Study Shows.” 

Even worse, more and more frequently we are seeing providers, government and the media basing their opinions or actions on poor evidence -- or many times the total lack of it.  I have a tee shirt which says: “Show me the evidence and critical thinking.”

It is time for people in pain as well as their advocates to understand research studies and hold accountable those that are cited.

Evaluating research is a little complicated and time consuming, but it is something every medical person needs to do.  More importantly, the media needs to justify their reliance on research and identify that what they are saying is true, rather than something totally lacking in validation and objectivity (which unfortunately is most often the case). 

After all, the media claim to do careful research before doing a story. Politicians should also have accountability for objective truth.

As people living in pain, our arguments and comments are more effective if we show that we know what we're talking about.  It may not change someone's mind if they are opiophobic or dislike and distrust people in pain, but it’s important to try.

I’ve made repeated requests to the Portland Press Herald to give me the citations for their claim that “studies have shown conclusively that opioids not only don’t work for chronic pain but make it worse.” I haven’t changed their minds, but it is ammunition in the battle for actual truth.

These are some of the terms the public and people in pain need to understand:

Correlation and causation: Probably the most important.  Just because something happens at the same time, does not mean one thing “causes” the other.    My husband teaches statistics at a university and the example he uses is when the number of new boat licenses increases the number of manatees being killed. This does not mean boat licenses kill manatees.  This correlation means causation thing is rampant in media stories about pain.

Anecdotes and surveys:  An anecdote is an account not necessarily true or reliable, because it is based on personal experience rather than facts or research.  For every anecdote, there are often many more which tell a totally different story. An example would be: "My son died of an opioid overdose. We have to stop these drugs from killing people." Any death is tragic, but opioids do not in themselves kill people. 

Surveys also rely on someone’s self-reporting.  The one used extensively by the media and politicians is that 3 in every 4 heroin addicts got their start taking prescription opioids. That particular survey relied on addicts to tell the truth, did not not include addicts outside of treatment, and most importunately did not include millions who have taken opioids for pain and never even touched heroin.  Surveys and anecdotes are worthless as evidence.   

Case studies:  These are things that happened to a person, group or situation at a single time and/or place; i.e. a case history.  The CDC makes use of case studies to “prove” in their seminars the correctness of their opioid guidelines.  Case studies are of interest, but are not valid evidence for the same reasons anecdotes are not.

Data mining: This is the process of collecting, searching through, and analyzing a database to discover patterns or relationships. In our case, it usually means they have gone through death certificates, insurance records and the like.  Once again, this is not a source of evidence as there is no way to verify the validity of the data, as well as other confounding factors.  Data mining is the CDC’s favorite method and it has been shown to be highly inaccurate. It does not have a place in medicine, except to develop insights and lead to actual research.

Statistics: These by themselves do not mean much. Researchers need to use the appropriate statistical analyses before publishing them.  Medical providers, media and politicians need to acknowledge what analysis method was used and what the outcomes were.

Qualitative vs quantitative: Qualitative research gathers information that is not in numerical form. For example, diary accounts, questionnaires, case studies and anecdotal accounts are used to gain an understanding of underlying reasons, opinions and motivations. Qualitative data is typically descriptive data and as such is harder to analyze than quantitative data. It can never be “proof.”

Quantitative research looks at numbers, it is the “hard” science. Quantitative research is used to quantify the problem by way of generating numerical data that can be transformed into useable statistics that can be evaluated.

Objectivity: Objectivity means being aware and honest about how one's beliefs, values and biases affect the research process. This also applies to the reviewing, reporting, and selection of research.  The media especially lacks objectivity in their reporting of all issues related to people in pain and the “opioid addiction epidemic”.

Method:  How the study was done; meta-analysis, random controlled trials, non-random controlled trials, survey, cohort or case controlled study, or even expert opinion. The latter is only acceptable when no other research exists on the subject.

Sampling: The number of participants and who they were. A small number has a lower strength of evidence.  My favorite example of a “who” was a study done which claimed to show analgesics caused people to be homicidal.  Their sampling took place in a prison where all the participants were murderers!  Doesn’t take a rocket scientist to figure out this was biased.

Strength of evidence: This is probably the most important term when it comes to research.  There are many different tables used (easy to Google) that show a hierarchy of what is strong evidence, what is weak and what is non-existent.  Even the CDC recognized the evidence for their opioid guidelines was weak to non-existent. Most studies on the opioid epidemic or people in pain are inherently weak because the evidence is so poor.  

Proof:  Research seldom ever provides “proof.”  If multiple studies come up with the same results, then some might call it proof; however it is safer to say “likely.”  When talking about pain, medications, interventions or even addiction, the word “proof” should be off the docket.

Critical thinking: Critical thinking is the identification and evaluation of evidence to guide decision making. Another definition is making reasoned judgments that are logical and well thought out, a way of thinking in which you don't simply accept all arguments and conclusions you are exposed to, but rather question such arguments and conclusions. 

Those who are prejudiced and biased against people in pain or opiophobic rarely use any critical thinking skills at all.  In fact, after a comment I had made on a newspaper article, someone assassinated my character by saying my head was filled with mashed potatoes and I lacked any critical thinking skills whatsoever.  There was more and it was pretty funny.  This unfortunately is characteristic of the media, politicians and general public. No matter what we say or how truthful our comments, they will not hear. 

Evidence based: This means looking at best available clinical evidence from methodical research.  The word term is thrown around lightly and unless you have the actual “evidence” to back it up, it is meaningless. 

Several years ago, I was part of the original Pain PEP (Putting Evidence into Practice) team for the Oncology Nursing Society. We studied pharmaceutical interventions for nociceptor and neuropathic pain in the adult cancer patients. It took us two years to evaluate recent guidelines and research studies, and to write our guidelines based on the strength of the evidence. If you say something is “evidence based,” be prepared to show it.

One last comment on the issue of research and pain management: There are integral difficulties in pain research as people vary in their reaction to pain, the cause of their pain, and how they respond to treatment. Any research that uses the term “chronic pain” is already working with a false premise because there are so many different types of pain that are persistent.  Any research that looks at a “class” of medication such as opioids or antidepressants is also employing a false basis as well.

Pain management is an art and a science, and any attempts to standardize it will only harm people in pain.  

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including a regular one on cooking with pain. 

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

Full Court Press on Opioid Pain Medication

By Pat Anson, Editor

A full court press is a defensive basketball tactic in which a team applies relentless pressure on an opponent the entire length of the court.

This past week felt like a full court press against prescription opioids, with government regulators, politicians, and even economists weighing in on the opioid crisis – almost all of them pointing a finger of blame at pain medication.

Where to begin?

On Tuesday, sixteen U.S. senators wrote a letter to the head of the Drug Enforcement Administration asking the agency to make further cuts in the production of hydrocodone, oxycodone and other opioid pain medications in 2018. The DEA has already reduced the supply of Schedule II opioids by 25 percent or more in 2017.

The letter, which was signed by 15 Democrats and one independent -- many from states where deaths from heroin and illicit fentanyl have eclipsed those from painkillers -- doesn’t even mention the role of illegal drugs in the overdose crisis, pinning the blame solely on pain medication.

“In order to effectively combat this raging crisis, stakeholders -- especially our federal oversight agencies -- must use every tool available to prevent the flood of addictive narcotic painkillers onto the market that can result in misuse, abuse, and diversion,” said the letter.

On Thursday, the Food and Drug Administration signaled that it was prepared to use some of those tools. An FDA funded report by the National Academies of Sciences, Engineering, and Medicine called for a national campaign to combat the opioid crisis, including more aggressive regulation of opioid medications and a “cultural change” in the way they are prescribed.

At the same time, the report warned that the illicit and prescription drug markets are "intertwined" and that "regulatory efforts designed to reduce harms associated with the use of prescription opioids may be contributing to
increased heroin use."

FDA commissioner Scott Gottlieb, MD, welcomed the report with a lengthy statement that completely ignored the role of heroin and illicit fentanyl in the opioid crisis.

“I’ve asked my FDA colleagues to take a fresh look at some key features of the agency’s regulation of opioids, including provider education, benefit-risk assessment in the pre- and post-market setting, and steps we can take to reduce overall exposure to these drugs,” Gottlieb said.

‘Extreme Amount’ of Opioids Prescribed

Also on Thursday, the Department of Health and Human Services’ Office of Inspector General (OIG) published a widely cited and inflammatory report claiming that over half a million Medicare beneficiaries were receiving high doses of prescription opioids.  The estimate is based on the premise that a daily morphine equivalent dose (MME) greater than 120 mg is a “high amount” and a dose of 240 mg or more is an “extreme amount.”

Those would be high doses for most pain patients, but not for Rick Martin, a retired Nevada pharmacist disabled by severe chronic back pain. Martin says he needs up to 300 mg (MME) of opioids daily just to be able to stand and walk for any length of time.

“I am really really incensed about the OIG using the word ‘extreme’ in defining people who take greater than 240 MME/day.  This is shouting fire in the movie theater,” Martin wrote in an email to PNN. “Patients who have long term persistent pain are where they are due to the medical community failing to correctly diagnose and treat what is causing the pain in the first place.  

“So in the OIG's eyes, not only am I a chronic pain patient on long term monitored opioid prescription medications, I am now considered EXTREME ! What a degrading moniker that is. In 6 months, I'll be called an EXTREME OPIOID ABUSER.  That's the next level to come down the pike.”

Like the senators’ letter to the DEA and the FDA study, the OIG report virtually ignores the illegal drug trade, instead blaming patients and providers for the opioid crisis. The report estimates that 400 doctors have “questionable” prescribing practices and 22,000 Medicare beneficiaries are doctor shopping.

“The extreme use of opioids and apparent doctor shopping described in this study put beneficiaries at risk and may indicate that opioids are being prescribed for medically unnecessary purposes and then diverted for resale or recreational use. It may also indicate that beneficiaries are receiving poorly coordinated care,” the report says.

On Thursday, the Justice Department also announced a nationwide crackdown on health insurance fraud and the illegal distribution of prescription opioids. Over 400 people were arrested nationwide, including many doctors, nurses and healthcare providers.

"While today is a historic day, the Department's work is not finished. In fact, it is just beginning. We will continue to find, arrest, prosecute, convict, and incarcerate fraudsters and drug dealers wherever they are,” warned Attorney General Jeff Sessions.

Opioid Crisis Affecting Job Market

Surprisingly, it was left to economists to take a more nuanced view of the opioid crisis – noting there are many other factors involved besides pain medication

Federal Reserve chair Janet Yellen told the Senate Banking Committee that economic despair was one reason that the labor force participation rate remains stubbornly low, despite declines in the unemployment rate.

“Unfortunately this is likely tied to the opioid crisis, the problems that many communities have. We’ve seen an increase in death rates due to despair, suicide, drugs in these communities,” Yellen said, adding that the United States is "the only advanced nation that I know of where in these communities we're actually, especially among less-educated men, seeing an increase in death rates partly reflecting opioid use."

Yellen was reacting in part to a Goldman Sachs report  which blamed opioids of all kinds – both legal and illegal – for keeping millions of Americans unemployed during their prime working years.

“Use of both legal prescription pain relievers and illegal drugs is part of the story of declining prime-age participation, especially for men,” economist David Mericle wrote in a research note that attributed a spike in overdoses to “heroin and illicit fentanyl users, most of whom previously used prescription opioids but switched to these cheaper, more accessible drugs.”

Trump Opioid Commission Delays Report

Curiously silent during a week full of opioid news was the White House Office of National Drug Control Policy, which quietly postponed the second meeting of President Trump’s Opioid Commission.  A notice published in the Federal Register Friday said the commission’s second meeting has been postponed until July 31, the second time the meeting has been rescheduled.  No explanation for the delay was given.

Also delayed was the commission’s interim report on how the federal government should address the opioid crisis, which is now over a month overdue.

At the commission’s first meeting in June, testimony was taken only from government officials and addiction treatment advocates. Pain management experts and patient advocates were not asked to appear, nor are they represented on the commission itself.

Proove Biosciences Linked to Fraud Investigation

By Pat Anson, Editor

A genetic testing company in southern California has been linked to a nationwide crackdown on healthcare fraud that resulted in criminal charges being filed against hundreds of doctors, nurses and medical professionals.

Among the defendants are three individuals affiliated with Physicians Primary Care of Jeffersonville, Indiana, who are accused of unlawfully dispensing oxycodone, hydrocodone and other opioid medications to patients without a legitimate medical need.

The charges also allege that Jeffrey Campbell, MD, and nurse practitioners Mark Dyer and Dawn Antle "caused Proove Bioscience, Inc., a genetic lab company, to falsely and fraudulently bill various health care programs for genetic tests administered to Physicians Primary Care patients that were not medically necessary and never interpreted."

Proove Biosciences is not formally charged in the grand jury indictment, which was unsealed yesterday in the U.S. District Court of Kentucky in Louisville. In an emailed statement to PNN, Proove's founder and CEO said the company cooperated with authorities and terminated its contract with Dr. Campbell when it first learned of the investigation in 2014.

"Since then, Proove has cooperated with both the FBI and US Attorney’s office on this case," said Brian Meshkin. "With regards to tests being 'medically necessary', Proove received written and signed determinations of medical necessity supporting the tests ordered and billed to insurance carriers just like every other laboratory which requires such a determination on a test requisition form. Thus Proove operated appropriately and consistent with usual and customary practices."

As PNN has reported, Proove’s headquarters in Irvine, California was raided by FBI agents last month, along with doctors affiliated with Proove in California, Florida and Kentucky. At the time, the FBI would only say the raids were part of a healthcare fraud investigation.

STAT News reported in February that the FBI and the Inspector General for the Department of Health and Human Services (HHS) were investigating possible criminal activity at Proove. Former and current employees interviewed by the FBI said agents were focused on illegal kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”

"Proove has been subject to a handful of inaccurate stories,” Proove said in a statement last month.  “We can no longer ignore these false stories based on unreliable sources, and filled with erroneous accusations... spread by a few disgruntled former employees and consultants.”

In all, 412 defendants have been charged nationwide in what the Justice Department calls its “largest ever health care fraud enforcement action.” Most of the charges, according to prosecutors, involve the illegal distribution of painkillers and $1.3 billion in various billing schemes that targeted Medicare, Medicaid and TRICARE, a health insurance program for veterans and their families.    

Attorney General Jeff Sessions said nearly 300 health care providers were being suspended or banned from participating in federal health programs.

“Too many trusted medical professionals like doctors, nurses, and pharmacists have chosen to violate their oaths and put greed ahead of their patients,” said Sessions. “Amazingly, some have made their practices into multi-million dollar criminal enterprises. They seem oblivious to the disastrous consequences of their greed. Their actions not only enrich themselves often at the expense of taxpayers but also feed addictions and cause addictions to start.”

Proove’s ‘Peer Reviewed’ Studies

Proove Biosciences promotes itself as a “leader in personalized pain medicine” and claims its genetic tests have been proven effective in clinical studies at identifying medications that can best treat pain and other health conditions. Critics say most Proove studies are not peer-reviewed and one genetic expert told STAT News the studies were “hogwash.”

Last month Proove claimed in a press release that 91% of patients in a peer-reviewed study reported pain relief after treatment changes prompted by its genetic tests. The press release said the study -- conducted by Katrina Lewis, MD, a member of Proove's medical advisory board who works at Benefis Pain Management Center in Great Falls, Montana – was “accepted for publication by the Journal of Addiction Research & Therapy.”

Not only has the study still not been published, but the journal’s publisher has been accused by the Federal Trade Commission (FTC) of deceiving researchers and readers about the true nature of its publications and peer review process.

According to the FTC complaint filed last August, OMICS International has created hundreds of "open access" online medical journals that publish articles with little or no peer review.

Researchers are also charged significant fees to get their articles published by OMICS, a "pay to play" policy that some consider unethical because it diminishes the quality of academic journals and the peer review process.

According to its website, OMICS publishes a dizzying array of over 700 online medical and scientific journals, ranging from the Journal of Hepatitis to the Journal of Yoga and Physical Therapy, "the official journal of Yoga Federation of Russia and the Hong Kong Yoga Association." 

“In reality, many of Defendants’ online publications do not adopt the rigorous peer review practices that are standard in the scholarly journal publishing industry,” the FTC complaint says. “In numerous instances, individuals who have agreed to serve as peer reviewers for Defendants either never receive any manuscripts to review or discover that, when they access the online manuscript review system to review their assigned articles, the articles have already been approved for publication. In addition, in numerous instances, consumers receive no edits or, at most, only stylistic edits before Defendants publish the work.” 

"As for the Journal of Addiction Research & Therapy, Proove can only speak to its experience with this particular journal and cannot comment on the allegations by the FTC," said CEO Meshkin. "Specifically for papers submitted to this journal, our R&D team and academic collaborators engaged in documented, extensive peer-review, received suggested edits and provided responses to the suggested edits to the manuscripts submitted for review and publication. Thus, Proove would certainly consider the publications accepted from Proove-affiliated authors in that journal to be 'peer-reviewed'." 

In March, OMICS published in the Journal of Addiction Research & Therapy a study by Proove which found that one of the company’s genetic tests could identify patients at high-risk of developing opioid use disorder. Proove said in a news release the study had been peer reviewed. 

In April, a second Proove study was published in Pharmacogenomics and Personalized Medicine, an online journal published by Dove Medical Press, another so-called predatory publisher that charges high fees to researchers to get their studies into medical journals.

"This is the first of many peer-reviewed publications over the next several months demonstrating the validity of Proove Opioid Risk (test), building on the existing published evidence," Dr. Svetlana Kantorovich, Proove's Research and Development director said in a news release.