Stop Demonizing the ‘Holy Trinity’     

Lynn Kivell Ashcraft, Guest Columnist    

If we are to have any hope of a rational, scientific discussion about the issues involved in both pain management and addiction treatment, we need to end patient shaming and the use of sensational language that has no basis in clinical practice.

First on my list is to stop using the term “Holy Trinity” when referring to the use of multiple medication classes to manage pain. It is a sensational propagandizing use of terminology that has no place in any meaningful clinical discussion.

Holy Trinity was a term coined by law enforcement when discussing the behavior of addicts. The original Holy Trinity – the so-called “Houston Cocktail” -- referred to the simultaneous ingestion of the short acting drugs hydrocodone (Vicodin), alprazolam (Xanax) and carisoprodol (Soma) by addicts. Other combinations of opioids, muscle relaxants and anti-anxiety drugs such as benzodiazepines are also used.

“The cocktail is commonly known on the black market as the ‘holy trinity’ and is particularly sought-after by addicts, but is also particularly dangerous,” is how the DEA describes the drugs in criminal complaints, search warrants and training guides.  

SOURCE: DEA TRAINING GUIDE

SOURCE: DEA TRAINING GUIDE

Taken together, the three drugs can be risky and cause respiratory depression, overdose and death. But when used under medical supervision, they enable individuals with painful and disabling conditions to improve their quality of life and restore bodily functions.

Holy Trinity was never used originally to refer to any medication combination prescribed by physicians caring for pain patients. But with the advent of the opioid crisis, the term is being used as a scare tactic by law enforcement and even some medical providers to deny patients a combination of medications previously used successfully.

The unintended consequence of this careless usage has been the deaths and needless renewal of pain and disability for patients who were being safely prescribed these medications.  

There is no one-size-fits-all treatment for chronic severe centralized pain. In fact, the current Pain Management and Dosing Guide from the American Pain Society lists opioids plus other central nervous system depressants and valium (a diazepine) as potential treatments for neuropathic pain.

It is well acknowledged that successful treatment often requires polypharmacy regimens tailored to the needs of individual patients to achieve pain relief and provide quality of life. The potential risks of using multiple medications can be reduced by prescribing both long-acting forms of these drugs and by directing patients to take them separately. 

To use the Holy Trinity as an inflammatory term is to demonize certain medications that have been abused by addicts while being used successfully by intractable pain patients. The use of this derogatory term has caused the undeserved transference of the deeply held negative societal bias against “addicts” onto some of the frailest and medically complex patients, many of whom are struggling to achieve some quality of life. 

According to the CDC, about 20 percent of adults in the U.S. have chronic pain and 8 percent have severe “high impact” chronic pain that frequently limits their life or work activities. The 2011 Institute of Medicine report puts the number of Americans with pain at 100 million, which is more than those living with diabetes, heart disease and cancer combined.

The difference between the two reports highlights some of the issues with using and understanding statistics.  However, no matter which report you use, both numbers represent a staggering number of Americans living in pain who deserve effective treatment.

Let’s lose the term Holy Trinity and allow doctors to prescribe whatever medications they deem necessary for the restoration of function and the relief of pain in their patients. Name calling and the use of disrespectful terminology doesn’t solve either the problem of addiction or the problem of pain.

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Lynn Kivell Ashcraft is an Analytic Software Consultant and writer who lives in Arizona. Lynn has lived with chronic intractable pain for almost 30 years and works with Dr. Forest Tennant as part of the Arachnoiditis Research and Education Project. 

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.

Overdoses Linked to Fake Pain Pills Draw Little Attention

By Pat Anson, PNN Editor

A mysterious lung illness linked to marijuana vaping has drawn nationwide attention this week. The CDC said there were 6 confirmed deaths and 380 cases of the illness, which one doctor warned was “becoming an epidemic.”

Even the White House has gotten involved in the vaping crisis, with President Trump calling for a ban on flavored e-cigarettes. “People are dying with vaping,” Trump said.

Meanwhile, an even more deadly health crisis continues to spread, drawing relatively little attention from the nation’s media and federal officials. Counterfeit blue pills made with illicit fentanyl are killing Americans from coast to coast.

This week, health officials in California’s Santa Clara County announced that 9 fatal overdoses have been linked to counterfeit oxycodone pills since January, including the recent deaths of a 15 and 16-year old.  

Local law enforcement has seized a large number of the blue tablets, which have an “M” stamped on one side and a “30” on the other side. They are virtually indistinguishable from real oxycodone.

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“The extent of circulation of these fake pills is unknown; however, they had been consumed by several of the people who died,” Santa Clara Public Health Director Sara Cody, MD, said in a statement. 

“Many opioid pills, which are made to look like real prescription medications, are now made by counterfeiting organizations. These pills are not prescribed, stolen, or resold by or from verified pharmaceutical companies, and there is no connection between their appearance and their ingredients. Many patients may not be aware of the risks of taking a pill that does not come directly from a pharmacy.”  

Mexican Oxy

The overdoses in Santa Clara County are not an isolated situation. Over 700 miles away, the Yakima County Coroner’s Office in Washington State warned that three recent deaths involved fake oxycodone pills with the same distinctive markings. Yakima is used as a major distribution center by Mexican drug cartels.

"Most of the time it comes from Mexico, but we haven't been able to pinpoint exactly which batch it's from and who is actually dealing it," said Casey Schilperoort, a spokesperson for the Yakima County Sheriff's Office.

Known on the street as “Mexican Oxy,” the pills were also found at the scene of four fatal overdoses near San Diego over the summer.  Ports of entry near San Diego are major transit points for counterfeit oxycodone smuggled in from Mexico. The pills are usually transported in vehicles, often by legal U.S. residents acting as couriers. They sell on the street for $9 to $30 each and have spread across the country.

In February, New York City police announced the seizure of 20,000 fake oxycodone pills. Overdose deaths in New York City are at record levels and fentanyl is involved in over half of them. Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine.

This week federal prosecutors in Cleveland indicted ten people for trafficking in fake oxycodone and other illegal drugs. The leader of the drug ring, Jose Lozano-Leon, allegedly directed operations using a cell phone smuggled into his Ohio prison cell.

Prosecutors say Lozano spoke frequently with the co-defendants and others to arrange drug shipments from Mexico to northeast Ohio. The ring allegedly specialized in counterfeit oxycodone.

"In Ohio and other parts of the country, we are seeing an increase in these blue pills that at first glance appear to be legitimately produced oxycodone, but in fact are laced with fentanyl,” said DEA Special Agent in Charge Keith Martin.

Ironically, the indictments were filed in the same federal courthouse where a major lawsuit against opioid manufacturers and distributors is expected to get underway next month.  

Chronic Pain Accelerates Dementia

By Dr. Lynn Webster, PNN Columnist

In 2017, JAMA Internal Medicine published a study that found older people with chronic pain experience faster declines in memory and are more likely to develop dementia.  While prior research had shown a link between chronic pain and brain damage, this was one of the first studies to specifically suggest that chronic pain can cause dementia.

The authors reported that people aged 60 and over with persistent pain experienced a 9.2% more rapid decline in memory score when compared to people of the same age without chronic pain. This means that people with chronic pain may experience more difficulty in managing their finances, medications and social connections.

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Dementia is a chronic condition of the brain that involves memory, personality and judgment. It is not a disease; it is a symptom of one or more diseases.

There are many types of dementia. Alzheimer’s disease is considered to be the most common.

Dementia usually worsens over time if the underlying disease remains static or progresses, as is the case with many chronic pain conditions.

There are an estimated 20 million Americans with high impact (the most severe) chronic pain who may be experiencing accelerated decline in cognition due to their pain. The amount of dementia appears to be associated with the severity and duration of chronic pain. Undertreated or untreated chronic pain may accelerate dementia.

Chronic pain affects an even larger percentage of elderly adults (one in three) than the general population. Since the prevalence of chronic pain increases with age, the probability of experiencing dementia increases as well. However, the reasons for that go beyond aging itself.

Seniors are more likely to take multiple medications that can contribute to mental confusion. On average, elderly people take five or more prescriptions. They may also use over-the-counter medications, which adds to potential drug-associated mental compromise.

Opioids, in particular, have been implicated in cognitive impairment. However, a study published in 2016 suggests there is no difference in cognitive decline between people on opioids and those on nonsteroidal anti-inflammatory drugs. The study's implication is that pain, not opioids, leads to cognitive impairment.

Brain Fog

Chronic pain appears to affect the function and structure of the hippocampus. This is the region of the brain that involves learning, memory, and emotional processing.

One explanation for the mental decline associated with chronic pain is that various areas of the brain compete for attention. Attentional impairment compromises memory by diverting attention to the areas of the brain processing pain. In effect, the brain is multi-tasking and favoring the processing of pain over cognition. This may, in part, explain the clinical phrase “brain fog.”

The Australian Broadcasting Company's "All in the Mind" website explains that pain damages the brain in several ways, including a change in the size of the thalamus and a decrease in the amount of a neurotransmitter (gamma-aminobutyric acid) the brain produces. In other words, chronic pain changes the brain structurally and functionally.

The prefrontal cortex is the part of the brain responsible for executive functions, such as cognition, social behavior, personality, and decision-making. It is also the part of the brain that modulates pain.

According to "All in the Mind," some researchers believe that chronic pain decreases the volume of the prefrontal cortex. Over time, brains damaged by pain lose the ability to handle pain — along with some of the personality attributes that make us who we are.

Brain Damage Can Be Reversed

The good news is that the brain damage caused by chronic pain can be reversed, at least to some extent. Unfortunately, the elderly are less likely to recover from dementia caused by chronic pain as compared with younger patients.

If pain is adequately treated, the brain may be able to regain its ability to function normally. A 2009 study of patients with chronic pain due to hip osteoarthritis showed reversal of brain changes when their pain was adequately treated. 

People who don’t have their acute pain managed are more likely to develop chronic pain. It is postulated that the changes in the brain that occur with chronic pain begin with the onset of acute pain. There is also some evidence that an individual’s genes may influence who is at greatest risk for developing brain damage from chronic pain and who is least likely to recover from it. 

Many people have criticized the concept of assessing pain as the 5th vital sign, and have called it a contributing factor for the opioid crisis. As I have said, pain may not be a vital sign, but it is vital that we assess it. Asking patients about their pain is critical to providing interventions that can mitigate the consequences of undertreated pain, including dementia. 

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

The information in this column 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.

One in Four Adults in England Take Addictive Meds

By Pat Anson, PNN Editor

Nearly 12 million people – about one in four adults in England -- are taking addictive prescription drugs to treat depression, anxiety, insomnia or chronic pain, according to a new review by Public Health England (PHE).

The review takes a cautionary view on the use of five drug classes – opioids, antidepressants, benzodiazepines, gabapentinoids, and so-called “z-drugs” such as zolpidem, zopiclone and zaleplon.

“The medicines we looked at help to make millions of people every year feel better and recover from their illness. Doctors can prescribe them because there is good evidence that they work, but they do have some risks,” the PHE report found.

Benzodiazepines, z-drugs, opioids and gabapentinoids are associated with dependence and withdrawal, while there’s a risk of withdrawal with antidepressants. When the drugs are taken in combination or in high doses, there is also risk of respiratory depression and overdose.  

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About half the patients prescribed the drugs in England had been taking them for at least a year — a sign of dependence. But the report cautions doctors not to abruptly discontinue the drugs and to taper them gradually, if at all.

“There is a view that a sub-population of chronic pain patients can be prescribed long-term opioids at relatively stable doses so that their analgesia and functioning can be maintained with good adherence and tolerable side-effects,” the report found.

“We do not want to put anyone off safely using medicines that could help them. Stopping or limiting the use of medicines could also cause harm, including increasing the risk of suicide or making people try to get medicines or illegal alternatives from less safe sources, such as illegal websites or drug dealers.”

Increasing Use of Antidepressants and Gabapentinoids

Antidepressants were prescribed to about 7.3 million people in England or 17% of the adult population. Opioids were prescribed to 5.6 million patients, followed by gabapentinoids (1.5 million), benzodiazepines (1.4 million) and z-drugs (1 million). Prescriptions for opioids, benzodiazepines and z-drugs are dropping, while the use of antidepressants and gabapentinoids is growing. 

Gabapentinoids such as pregabalin (Lyrica) and gabapentin (Neurontin) were originally developed to treat epilepsy, but the drugs are increasingly prescribed in the UK to treat neuropathy and other types of chronic pain. PHE researchers found only marginal evidence that they are effective for pain and alarming signs that they are being misused. 

“Gabapentinoids have come to be used for a wider range of indications than is supported by the evidence or their licensing, and they have sometimes been prescribed in place of opioids or benzodiazepines in the likely-mistaken belief that they are less liable to misuse or dependence, and lack of awareness of the withdrawal problems that can arise when prescribing is stopped,” the report said. 

Prescriptions for opioids and gabapentinoids were 1.6 times higher in parts of England with more poverty. People in poor areas are also more likely to be prescribed medicines for longer periods. Prescription rates for women are about 1.5 times higher than for men. Prescription rates also increased with age.

DEA Proposes More Cuts in Rx Opioids

By Pat Anson, PNN Editor

For the fourth consecutive year, the U.S. Drug Enforcement Administration is proposing steep cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances.

In a notice published today in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 19 percent and oxycodone by 9 percent in 2020. The supply of hydromorphone, oxymorphone, and fentanyl would also be cut.

“The aggregate production quota set by DEA each calendar year ensures that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” acting DEA Administrator Uttam Dhillon said in a statement.

“DEA takes seriously its obligations to both protect the public from illicit drug trafficking and ensure adequate supplies to meet the legitimate needs of patients and researchers for these substances.”

In setting annual production quotas for controlled substances, DEA considers various factors such as medical need, estimates of retail consumption based on prescriptions, and forecasts from opioid manufacturers. Added to the mix this year is diversion.

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The five opioids being cut are subject to special scrutiny under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which was signed into law by President Trump on October 24, 2018. The law requires DEA to estimate the amount of diversion of the five opioids and “make appropriate quota reductions.”

The agency estimated that 57 kilograms – about 125 pounds – of oxycodone were diverted or stolen in 2018, along with 24 kilograms (53 pounds) of hydrocodone. There was diversion of relatively small amounts of fentanyl, hydromorphone and oxymorphone last year.   

Cuts Began in 2016

The DEA first began cutting the supply of opioids in 2016 during the Obama administration and the trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

If approved, the 2020 production quotas would amount to a 60 percent decrease in the supply of hydrocodone since 2016 and a 48 percent cut in the supply of oxycodone.

While overdoses involving prescription opioids have been declining, they’ve been offset by a growing number of deaths attributed to illicit fentanyl, heroin and other street drugs. “Mexican Oxy” – counterfeit oxycodone pills laced with fentanyl – are being trafficked throughout the United States and are blamed for overdoses from New York City to San Diego.

In addition to the five opioids, the DEA is setting production quotas on more than 250 Schedule I and II controlled substances. The agency is proposing to increase the amount of marijuana that can be produced for research by almost a third, from 2,450 kilograms in 2019 to 3,200 kilograms -- almost triple what it was in 2018. The increase reflects growing interest in marijuana research.

Public comments on the DEA proposal will be accepted until October 10. The agency will publish another notice later in the year on its final decision and begin informing drug manufacturers of their quota allotment.

Praying for a Miracle

By Stephanie King, Guest Columnist

Up until May of 2010, everything was pretty easy going as far as my health was concerned. I was a happily married 22-year old and mother of a sweet one-year old boy. Then one fateful afternoon all of that changed.

There was a bad storm that day but we had to pay bills. My family and I ended up hydroplaning off the road and crashing into trees.

Luckily, our son was unharmed and my husband, while it was bad, suffered nothing worse than a broken leg.

I had the worst of the injuries and needed surgery. I broke my right foot in three places and my back in five. One of those breaks was a compression burst fracture, which means that my vertebrae basically exploded from pressure. 

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Unfortunately, I also developed MRSA, a severe and dangerous bacterial infection. This meant packing the open, oozing wounds every day. Instead of getting better, the infection spread through my back and within a couple of months turned into sepsis. Two more surgeries and six months later, I was finally infection free.

A few years later, my pain was increasing due to degenerative disc disease and arthropathy, so my pain specialist started pushing epidural steroid injections. I was already on fentanyl and MS Contin, so I figured I would give it a shot. This would be the biggest mistake of my life.

I ended up having about ten injections. The last one caused extreme levels of pain and my body felt strange that night. I refused to get any more after that. 

Not long afterwards, I began developing neurological pain that I wasn't used to. Sometimes it felt like warm water running down my legs. Sometimes it was stabbing and biting sensations. Sometimes it felt like my bones were snapping. I didn't make the connection between the epidural and the nerve pain. I assumed it was a pinched nerve, because my back was so messed up. 

STEPHANIE KING

STEPHANIE KING

Then in the fall of 2016, my inner calves began to go numb. The numbness rapidly spread up my legs and into my groin. My GP admitted me into the hospital and I had an MRI done.

That day I heard the words I will never forget, the words that changed my life forever: Adhesive Arachnoiditis.

It was explained to me that this is a disease where scar tissue is engulfing spinal nerves, blocking the flow of spinal cord fluid because of inflammation of the arachnoid lining around the nerves.

The more I learned about Arachnoiditis, the more I realized I was doomed to a lifetime of unrelenting pain, a level of pain some doctors have compared to that of bone cancer. I learned of the possibility of paralysis. I learned how there is no cure, just medication to try to manage the disease symptoms and slow down its spread.

I was devastated but kept pushing on, ignoring the pain as much as possible.

Just over a year later, I learned something else. My birth control had failed. I was pregnant with our daughter. My pain specialist immediately dropped me. My obstetrician panicked and tried to get me in with another pain management doctor due to fear of a miscarriage.

I kept hearing how no one would see someone who was pregnant and not already an established patient at their practice. I was referred to a neurologist, but he told my doctor that there was nothing that he could give me that would be safe during pregnancy.

During my pregnancy, the Arachnoiditis symptoms increased tenfold. The burning in my feet and hands became unbearable. I'm one of the "lucky" Arachnoiditis patients who has scar tissue far enough up their spine to effect my arms and hands as well. I began jerking uncontrollably and developed tremors. I spent most of my pregnancy crying and screaming.

We have a beautiful daughter now! She is so sweet and smart! Unfortunately, my symptoms never subsided. I still don't have a pain management doctor. No pain specialist will see me.

I fear I was red flagged for doctor shopping, even though it was just my obstetrician trying to get me treatment. I have finally started seeing a neurologist but until he has reviewed all of my MRIs, no treatment will be given. I won't see him again for another month.

I live in never-ending pain. I rely on family a lot to help care for my children while my husband works. I have come to realize I have no good options at this point. I can continue on in pain and being a total burden to my family, just becoming more burdensome over time.

I could turn to marijuana but it is illegal in my state. My children could be taken away and I could go to prison. I could commit suicide but that would scar my children and further hurt the rest of my family. I am stuck.   

There are times I pray for death. I pray for the body I once had. I pray I could be the mother and wife I once was. I pray for anything to make it stop, even for just a little while. I pray for a miracle.

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Stephanie King lives in Alabama.

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

The information in 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.

Feds Warns CBD Marketers Again

By Pat Anson, PNN Editor

The Federal Trade Commission (FTC) has warned three companies that sell cannabidiol (CBD) oils, tinctures, edibles and other products to stop making claims that CBD can be used to treat pain and other chronic illnesses.

In letters to the companies, which the FTC is not identifying, the agency warned that it is illegal to advertise that a product can prevent, treat or cure illnesses without scientific evidence to support such claims.

One company’s website claims CBD “works like magic” to relieve “even the most agonizing pain.” Another company advertises CBD as a “miracle pain remedy” for both acute and chronic pain, including pain from cancer treatment and arthritis.

The FTC said the third company’s website promotes CBD gummies as highly effective at treating “the root cause of most major degenerative diseases, including arthritis, heart disease, fibromyalgia, cancer, asthma, and a wide spectrum of autoimmune disorders.” The company also claims its CBD creams and oils can relieve arthritis and fibromyalgia pain.

“In the letters, the FTC urges the companies to review all claims made for their products, including consumer testimonials, to ensure they are supported by competent and reliable scientific evidence,” the agency said in a statement.

The letters also warn that selling CBD products without substantiation could violate the FTC Act and may result in legal action. The companies were given 15 days to respond.

In March 2019, the FTC and Food and Drug Administration sent similar warning letters to three companies -- Nutra Pure, PotNetwork Holdings, and Advanced Spine and Pain — for making false and unsubstantiated health claims about a variety of CBD products.

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Nutra Pure, which makes a line of hemp oil, now has a lengthy disclaimer on its website stating that its products “have not been evaluated” by the FDA and that they “are not intended to diagnose, prevent, treat, or cure any disease.”

But when we posed as a customer in an online chat with “Kristen,” a NutraPure representative, we were assured that hemp oil can treat pain.  

Customer: “Do your products help treat pain?”

Kristen: “There are numerous studies showing CBD has the ability to provide therapeutic benefits in the treatment of various conditions, including chronic pain, arthritis, anxiety/depression, nausea, epilepsy, fibromyalgia, glaucoma and many other ailments.”

Customer: “Which one of your products helps treat fibromyalgia?”

Kristen: “We recommend starting with our 300 or 600 mg bottle.”

Customer: “Will that help joint pain?”

Kristen: “They are like an all in one type product.”

Customer: “What does that mean?”

Kristen: “One product helps with all types of conditions.”

Customer: “Including pain?”

Kristen: “Yes.”

CBD is a non-psychoactive chemical compound derived from the cannabis plant. Much of it comes from hemp – a less potent strain of marijuana – that was legalized under the 2018 Farm Bill. There are literally thousands of CBD products on the market being sold online and over-the-counter without a prescription, often with dubious claims about their health benefits.

FDA and FTC enforcement actions against CBD marketers are sporadic and have usually only targeted small companies. But an FDA warning letter in July to Curaleaf, a Massachusetts company that sells CBD products nationwide, had an immediate impact on one large retailer. CVS Pharmacy pulled most Curaleaf products from its stores.