Ignoring the Evidence in Canada

By Marvin Ross, Guest Columnist

For those of us north of the border who are defending against the assault on pain patients, it was very gratifying to see the American Medical Association come out against the “inappropriate use” of the CDC guideline on opioid prescribing.

Sadly, we cannot hope that the Canadian Medical Association (CMA) will do the same. The CMA embraced the Canadian guideline – which is modeled after the CDC’s -- and argued for better evidence on the safety and efficacy of prescription opioids.

Sadly, how Canadian officials evaluate evidence is suspect. Jason Busse, the chiropractor who chaired the Canadian guideline, contends that no randomized controlled trials (RCTs) have been done on opioids that follow patients for longer than six months. He tweeted that to me after I challenged him on the results of an analysis that concluded that “to dismiss trials as ‘inadequate’ if their observation period is a year or less is inconsistent with current regulatory standards.”

I pointed out that multiple published studies and over 1.6 million patients maintained on doses over 200mg MME (morphine milligram equivalent) disprove his claim opioids don’t work long term.

Busse’s reply was, “Yes - the CDC guideline excluded all trials of less than 1 year duration. The Canadian guideline did not. Nonetheless, there are no RCTs of opioids that follow pts. For more than 6 months.”

He did not reply to my comment that Prozac was approved for use based on trails of only 12 weeks duration and that many patients take anti-depressants for years. It has always seemed strange to me that McMaster University, which led the development of the Canadian guideline, is the home to evidence based medicine. One of the co-ordinators of the guideline is Dr. Gordon Guyatt, who is credited as the one who brought evidence based studies to the world.

The most flagrant avoidance of evidence is by Health Canada, which continues to insist that high rates of opioid prescribing is one of the main causes of the opioid crisis. Ann Marie Gaudon, a columnist for PNN, has been attempting to find out what evidence Health Canada has to make that claim.

Not only have they not responded to her query, but her call to their office at the end of October resulted in one of the most bizarre phone calls ever heard. Syndicated radio show host Roy Green devoted two episodes to what can only be described as a “Who's on First” discussion with a government official.

Health Canada now mandates that every prescription issued for an opioid carry a sticker and a leaflet warning of addiction risks. A total wasted effort. The evidence that prescriptions opioids are a significant part of the problem is lacking.

The Ontario Drug Policy Research Network just released a database that disproves claims that prescriptions are a major cause of opioid overdoses. It shows that opioid prescriptions in Ontario have been declining for years, as they have in the United States.  About two-thirds of the opioid prescriptions written in 2015 were for patients over the age of 45 and less than 2 percent were for fentanyl.

Contrast those stats to information put out by this same agency on opioid deaths. Accidental overdoses among those 15 to 44 accounted for nearly 60% of opioid deaths. And the most common opioid involved in overdoses was fentanyl – most of it illicit and obtained on the black market.

It would be very refreshing if governments and regulators in Canada actually looked at their own data before cracking down on prescriptions for legitimate pain sufferers. That may be too much to expect, but one can always hope.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

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.

Is Kratom Being Spiked With Other Drugs?

By Pat Anson, PNN Editor

It’s no secret that illicit fentanyl has become a scourge on the black market. The potent synthetic opioid – about 100 times stronger than morphine --  is now involved in over half of U.S. overdoses. Fentanyl is being found in a wide variety of street drugs, including heroin, meth, cocaine and marijuana, and it is increasingly used in the manufacture of counterfeit painkillers and other fake medications.  

“As traffickers have expanded into the sale of fentanyl-containing counterfeit pills, the scope of users who were exposed to fentanyl increased significantly; the prescription pain reliever misuser population is almost ten times that of the heroin user population,” a recent DEA report warns. “The presence of fentanyl-containing counterfeit pills in an area is increasingly associated with spikes in overdose deaths.”

Although there is no hard evidence that drug dealers are mixing fentanyl with kratom to boost its potency, some in the kratom community think it is inevitable that someone will try. There have already been cases of kratom products being adulterated with hydrocodone and other opioids.

“I don’t know that there’s been a case of fentanyl in kratom, but since that’s what they are finding in everything else and that is the most dangerous drug out there now, it stands to reason that someone who would spike kratom with hydrocodone would now spike it with fentanyl either wittingly or unwittingly,” said Jane Babin, PhD, a molecular biologist and consultant to the American Kratom Association (AKA), an advocacy group for kratom vendors and consumers.

Like other dietary supplements, kratom products are essentially unregulated and there are little or no quality controls.

In an effort to change that, this week the AKA officially launched a good manufacturing practice (GMP) program, which will require producers of kratom products to meet strict manufacturing standards verified by a third-party auditor if they want to be certified by the AKA.  

"The AKA GMP Standards Program will help reassure the public and demonstrate to the FDA, DEA, lawmakers, and others that the kratom industry is acting responsibly," AKA president Dave Herman said in a statement. 

"The AKA GMP Standards Program will also protect kratom consumers from unscrupulous vendors who produce kratom products using sloppy manufacturing procedures that allow for contamination, and equally important the standards program will exclude vendors who deliberately adulterate kratom products to boost their effect by adding dangerous and sometimes deadly substances like fentanyl or morphine." 

In recent years, millions of Americans have discovered kratom, which has been used in southeast Asia for centuries as a natural stimulant and pain reliever. Kratom is widely available online and in smoke shops, but the quality of what’s being sold and where it comes from is often unknown – even by the people selling it.

“The stuff that’s sold as kratom in the United States cannot be reliably proven to be kratom,” Edward Boyer, MD, a Professor of Emergency Medicine at Harvard Medical School, recently told PNN.  “There is evidence to suggest that some of the kratom sold in the United States is adulterated to make it more potent, to make it more powerful.”

Boyer says some kratom products have been found to contain artificially high levels of 7-hydroxymitragynine, one of the naturally occurring alkaloids that make kratom act on opioid receptors in the brain. Manufacturers may also be lacing kratom with opioids and other drugs.

“One theory is that some unscrupulous vendors may be spiking kratom with something more potent to drive business. It may be even more prevalent than we know, which could account for some of the reports on Reddit and Blue Light (online message boards) that say kratom is addictive and it does lead to euphoria,” Babin said in an email.

A handful of states have already banned kratom and there is speculation that the DEA will soon try again to schedule it as a controlled substance, something the agency backed away from in 2016 after a public outcry. The FDA has recently mounted a public relations campaign against kratom, what the AKA calls a “shadow ban” that has led to kratom shortages.

Could the AKA’s effort to improve the quality of kratom products backfire by giving ammunition to federal regulators who want a nationwide ban?

“That kratom may be adulterated is not a reason to ban it.  There are reports all the time of dietary supplements, even ones sold by reputable companies like GNC and Vitamin Shoppe, are adulterated with prescription drugs, banned substances and who knows what else,” says Babin.

“The other thing to consider is that if kratom is banned, demand may lead to a black market.  It will likely be smuggled in and/or products not containing kratom will be sold as kratom and those may be spiked with other substances, including fentanyl.”

Lessons from 'American Overdose' on the Opioid Crisis

By Roger Chriss, PNN Columnist

The book “American Overdose: The Opioid Tragedy in Three Acts” by Chris McGreal takes a hard look at the opioid crisis. The book focuses on the legal and political side of the crisis, along with a history of Purdue Pharma and OxyContin, and a detailed description of pill mills and rogue pharmacies in Appalachia.

“It is a tragedy forged by the capture of medical policy by corporations and the failure of institutions in their duty to protect Americans,” is how McGreal describes the genesis and evolution of the crisis.

The book highlights the massive collusion and corruption in communities in West Virginia and Kentucky, leading to the Williamson Wellness Center and other pill mills that were protected by law enforcement, ignored by state and federal regulators, and encouraged or exploited by drug manufacturers and distributors.

McGreal also traces the history of Purdue and the Sackler family, and how their efforts to improve pain management led to the creation of the blockbuster drug OxyContin. He explains how Purdue’s marketing claims “proved to be demonstrably false, including an assertion that addiction is rare when opioids are taken under a doctor’s care.”

However, McGreal does not depict Purdue as a lone bad actor. Instead, federal and state dysfunction and disinterest contributed to the crisis. “The FDA wasn’t the only one to drop the ball. A clutch of federal agencies with long names have responsibility for combating drug addiction and overdose,” he wrote. And they all failed.

The failure was both systemic and systematic. As the crisis unfolded, local law enforcement had to contend with “indifference and what they regarded as the political cowardice of the system.” Perhaps more important than the cowardice and corruption was greed, not just corporate greed but also local greed for the money brought in by pill mills: “The businesses did good. You had pharmacies that were doing really good.”

The problem soon extended far beyond Appalachia. Among the earliest and biggest pill mills was American Pain, set up in 2007 near Fort Lauderdale, Florida by twin brothers Chris and Jeff George – neither of whom had medical training.

Opioid addiction also rose across the nation because of cultural factors, writes McGreal. In Utah, “the dominance of the conservative Church of Latter-day Saints appeared to be a cause of addiction, not a deterrent” because of the church’s “toxic perfectionism.”

Government agencies and officials were encouraged to ignore it all. Florida Sen. Marco Rubio’s office wasn’t interested in pursuing pill mills and the “political leadership within Florida wasn’t much better.”

Rudy Giuliani, Eric Holder, and James Comey all helped Purdue, according to McGreal, by delaying investigations of the company as addiction and overdose rates rose rapidly in the 2000’s.

The CDC’s involvement is described as delayed and dysfunctional. "Until 1998 the United States used a classification system lumping heroin, morphine, and prescription opiate deaths together," McGreal points out. Even when CDC researcher Len Paulozzi documented rising trends in overdose deaths, no one paid serious attention until Thomas Frieden, MD, became director. Even then, serious flaws remain in how the CDC reports on overdose deaths.  

Anti-opioid activists Andrew Kolodny, MD, founder of Physicians for Responsible Opioid Prescribing (PROP), and PROP President Jane Ballantyne, MD, sounded warnings about opioids, but offered little in the way of solutions outside of cutting off prescriptions. Many of their warnings proved to be unfounded, in particular with the opioid analgesic Zohydro. The drug was approved by the FDA amid dire warnings of a major spike in addiction and overdoses, but “there was no great surge of overdoses because of Zohydro.”

“FDA officials don’t like Kolodny. They characterize him as unreasonable and difficult. One described him as a ‘complex character’,” McGreal writes.

Similarly, the 2016 CDC opioid prescribing guideline is described as too late to be useful. McGreal looks closely at the debate about the CDC guideline and recommendations from the 2017 opioid commission set up by President Trump. But despite these much-touted steps, “little changed on the ground for states desperate for treatment facilities and help with the social costs of the tragedy.”

The book concludes on a pessimistic note, captured in a comment from Nathaniel Katz, MD, about opioid addiction and overdose: "I don’t really see any prospect for intelligent policy in this area in the United States.”

McGreal summarizes his ideas with an indictment of American culture.

"In large parts of the United States, opioids were popular because they were a fix. A fix for emotional pain. A fix for failing bodies. A fix for struggling to make it in a society that promises so much, and judges by what is achieved, but turns it back on so many of those who fail to live up to that promise," he writes.

If “American Overdose” offers lessons, it is that the opioid crisis is a result not only corporate greed but also American culture; in particular politicians, regulators and a broader medical industry with agendas contrary to the public good. The book is an origin tale of the opioid crisis that offers little hope for the future.

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. 

Opioid Hysteria and the Demonizing of Dsuvia

By John Burke, Guest Columnist

Recently the FDA approved a new sublingual formulation of sufentanil -- called Dsuvia -- for the management of moderate to severe acute pain in hospital-like settings. This would include surgical centers and emergency departments.

When the FDA announced this approval, several so-called experts claimed that Dsuvia – which is a potent opioid – would worsen the already out of control opioid problem. They said it would quickly find its way to the streets of America and kill even more of our citizens addicted to opioids. They can’t imagine why the FDA would approve such a killer drug!

Dsuvia was originally developed by AcelRx Pharmaceuticals, in cooperation with the U.S. Department of Defense, to treat battlefield wounds. The single dose formulation is designed to enter your body and provide pain relief faster than the traditional intramuscular injections that are now standard in treating traumatic injuries.

I can only imagine the horrendous wounds that are present on the battlefield. Offering faster pain relief seems like a great option, to say the least!  

ACELRX PHARMACEUTICALS

Dsuvia will also be used in our nation’s emergency departments and other healthcare facilities to offer faster pain relief to patients who suffer traumatic injuries. The drug will not be available in retail pharmacies or for most prescribers to order up for a patient. Doctor shoppers, script scammers and others that prey on retail pharmacies will have no access to this pain reliever. Those involved in armed robberies or burglaries of retail pharmacies will also have zero access.

Who will have access to Dsuvia are healthcare employees -- nurses, doctors and other medical professionals who already have access to a whole host of opioid drugs. There is no question that Dsuvia could potentially be a target of a small group of professionals who suffer from addiction problems. However, the illegal diversion and sale of this specific medication seems less likely in healthcare facilities.

Dsuvia will be more easily identified when it is diverted due to its limited availability and usage. Addicted healthcare employees will likely opt for more commonly used opioids like morphine and hydromorphone rather than a rarely used medication that will be easily missed when diverted.

The other part of this equation, that was either not considered by critics or didn’t suit their narrative, is that diversion inside healthcare facilities virtually always involves self-addiction. This means that even if an opioid is stolen by an employee inside one of these facilities, it will rarely make it to the street and cause more deaths.  

AcelRx has already developed a Risk Evaluation and Mitigation Strategy (REMS) involving RADARS, a nationwide drug abuse surveillance system, to monitor any diversion of Dsuvia and provide quarterly reports to law enforcement. In the interest of full disclosure, I am on the Scientific Advisory Board of RADARS.

Dsuvia has great potential to provide quick relief to trauma patients in a focused setting. Its diversion potential, especially to the public, is almost nil. Demonizing a drug without any real knowledge of its legal distribution and potential for diversion is irresponsible to say the least.

The drug problem in America primarily involves street drugs such as heroin, illicit fentanyl, and more recently crystal methamphetamine and cocaine. Even as the prescribing of opioids has dropped over 30% in recent years, drug deaths continued to rise. The reason is the increased supply of street drugs supplied by cartels that continue to profit from our nation’s addiction.

Put the blame where it belongs, and don’t ostracize a legitimate new pain drug that any of us might need in an emergency.

John Burke spent nearly 50 years in drug and law enforcement in southwestern Ohio. John is a former president of the National Association of Drug Diversion Investigators and is the president and founder of the International Health Facility Diversion Association, a non-profit devoted to the issues surrounding the diversion of controlled substances from healthcare facilities.

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.

FDA Warns About Unapproved Drugs in Pain Pumps

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning patients and healthcare providers about serious complications that can occur when using medications not approved for use with intrathecal pain pumps. The agency says it has received “numerous reports” of pump failures, dosing errors, infections and other safety issues.

Pain pumps are implanted under the skin, usually near the abdomen, and deliver medication through a catheter directly into spinal fluid to treat chronic pain. They require a healthcare provider to periodically refill the pump with pain medication. The pumps are generally used as a last resort for patients whose pain is not adequately managed by oral medication, surgery and other treatments.

Currently, there are only two FDA-approved medications for intrathecal pain pumps; Infumorph (a morphine sulfate solution) and Prialt (a sterile solution).

Drugs approved for intrathecal administration must meet additional safety standards because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses.

The FDA has found that some patients are being treated with medications that are not approved for pain pumps – including hydromorphone, bupivacaine, fentanyl and clonidine – as well as compounded medications.

One reason patients may not be using Infumorph is that it is currently listed on the FDA’s drug shortage list. Some patients may also believe the unapproved drugs are more effective, although the FDA says they are still too risky.  

“While medical devices, such as implanted pumps that deliver medication directly into the spinal fluid, have the potential to play an important role in treating pain, their use must be judicious and their instructions for use must be carefully followed. This is especially true when it comes to implantable pumps that deliver analgesic medicine directly into the nervous system,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

The FDA says the failure rate of the pumps more than doubles when unapproved medications are used. Some drugs may contain preservatives that can damage the pump tubing or cause corrosion. Dosing errors can also occur because the software on pain pumps is only designed to calibrate doses with approved medications.

“FDA acknowledges that some patients being treated for pain may not be adequately managed by medicines approved for use with these pumps; however, the use of medicines not approved with the implanted pumps are associated with additional risks,” the agency said. “The FDA recommends that health care providers review the implanted pump labeling to identify the medicines and medicine concentrations approved for use with the specific pump.”

Patients and providers who experience an adverse event with an implanted pump or suspect one is having problems are encouraged to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Is Palliative Care an Option for Chronic Pain Patients?

By Rochelle Odell, PNN Columnist

Most of us have heard about 2016 CDC Opioid Guideline, which is supposed to be a voluntary guideline for primary care physicians treating non-cancer pain.

What has happened? In the span of two years the guideline has seemingly become law. Countless pain patients have made the trek to their doctor dreading the thought that their lifeline -- opioid pain medication – will be reduced or even discontinued.

Pain patients are often forced into surgical procedures such as epidural steroid injections or implants of spinal cord stimulators and other medical devices. The implants and injections all too often create more problems than they help. I know because I have had three different stimulators implanted and removed, as well as two pain pumps. The devices ultimately damaged my spine, compounding my Complex Regional Pain Syndrome (CRPS). 

Many of us are told if we do not undergo these invasive procedures our opioid medication will be stopped.  We are then forced to find a new physician for pain medication, a search that is often futile.

What happened to “patient driven healthcare” and freedom of choice in the so-called opioid epidemic? Is there anything patients can do?

Yes, we can request our physician determine if we meet the requirements for palliative care, which is specifically exempt from the CDC guideline.

Palliative care is often confused with end-of-life or hospice care, but imminent death is not a requirement for palliative care. The CDC defines palliative care in a way that many chronic and intractable pain patients would qualify for:

“Palliative care is defined… as care that provides relief from pain and other symptoms, supports quality of life, and is focused on patients with serious advanced illness. Palliative care can begin early in the course of treatment for any serious illness that requires excellent management of pain or other distressing symptoms for cancer.”

The World Health Organization (WHO) takes a similar broad view of palliative care:

“Palliative care is an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.”

According to WHO, palliative care should include “a support system to help patients live as actively as possible” and “enhances quality of life.”

If these palliative care conditions are met, does it mean we are safe from having our opioid medication cutoff? Not necessarily. but it’s an option we should ask our doctors about.

Therein lies a possible roadblock. Too many physicians, nurses and healthcare organizations still associate palliative care with cancer and other diseases where the only outcome is death. 

The Alliance for the Treatment of Intractable Pain (ATIP) is working to enhance and clarify the definition of palliative care to include those suffering from chronic, intractable pain that may not be terminal. Cancer pain isn't necessarily different or anymore painful than the pain suffered by CRPS patients. Our pain is often worse, as there is no end in sight. The pain lasts a whole lifetime and we do not get better.

A case in point regarding the confusion over palliative care. A friend of mine was told that she qualified for palliative care. Great, one might think.  Her pain medication is still being prescribed, but her physician is afraid of losing his license and will not continue to prescribe her current dose or increase it. She will have to find a new pain management physician, assuming she can find one. 

I have been requesting for over two months that I be evaluated for palliative care, but my own pain management group "does not do palliative care." My case manager told me palliative care is only meant to keep the patient out the hospital.

My primary care physician's office has been working on my request and recently a doctor from Home Health Care came to my home to evaluate me. Not for palliative care, but for Transitional Care Management (TCM), a term I had not heard of. 

TCM is very much like palliative care in that the patient receives care from any needed medical specialty. A support system is put in place and whatever specialist I need to see will be covered.  The physician who did the evaluation based it not only on my medical records but by interviewing me and going over all my physical and mental health requirements. He noted I had been on high dose opioids and anti-anxiety medication and functioned with both them. He also recommended that my opioid medications be increased.

Will they be increased? I don't know yet, but a Home Health Care nurse will now be coming to my home on a regular basis. Unless I am unconscious and basically on death's door, I will not go to an emergency room for treatment. I refuse to wait hours on end only to be treated like a drug seeker. The nurse will come to my home and give me opioid medication if I need it. That is a definite plus and something I will not abuse.

These two avenues of palliative care and transitional care management appear to be a chronic pain patient's only options. Many doctors may not initiate either one. It is often the patient or patient's family who must push for care. Being alone and with no help means I will have to do more research and seek care even if it means contacting my physician's office multiple times. It’s the only option I have.

Rochelle Odell resides in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

Drug Price Hiked 600% to Capitalize on Opioid Crisis

By Pat Anson, PNN Editor

A U.S. Senate report and 60 Minutes are highlighting how a Virginia drug maker exploited the opioid crisis by substantially raising the price of an overdose recovery drug and passing much of the cost to taxpayers.

The report by the Senate Subcommittee on Investigations found that Kaleo, a privately-owned pharmaceutical company, raised the price of its naloxone auto-injector Evzio by over 600% to “capitalize on the opportunity” of a “well established public health crisis.” As a result, the report estimates the U.S. government paid over $142 million in excess costs to Kaleo.

Naloxone is usually administered by injection or in a nasal spray to quickly reverse the effects of an opioid overdose. Syringes containing naloxone typically cost about $15 each, but Kaleo’s two-dose Evzio injector now sells for over $4,000. The original price was $575.

“Naloxone is a critically important overdose reversal drug that our first responders have used to save tens of thousands of lives,” subcommittee chairman Sen. Rob Portman, R-Ohio, said in a statement. “The fact that one company dramatically raised the price of its naloxone drug and cost taxpayers tens of millions of dollars in increased drug costs, all during a national opioid crisis no less, is simply outrageous.”

“We raised the price to improve access to this product,” Kaleo CEO Spencer Williamson told 60 Minutes. “The big misperception is that by raising the price of Evzio we reduce the access to this product. The exact opposite is true.”

Prescriptions for Evzio increased substantially after the price increase, but largely because Kaleo urged its sales department to have doctors sign prior authorization forms for patients stating that “Evzio was medically necessary.” Under that language, Medicare had no choice but to pay for Evzio at nearly full price.

When it was approved by the Food and Drug Administration in 2014, federal health officials called Evzio a “more user-friendly version” of naloxone because the injector gives verbal instructions on how to use it and can be administered by anyone.  Evzio was given fast-track status by the FDA and approved in less than 15 weeks without an advisory committee hearing.

“The approval of this product is great,” Andrew Kolodny, MD, founder and Executive director of Physicians for Responsible Opioid Prescribing (PROP) told Medscape at the time.

Kaleo began raising the price for Evzio the following year. By 2018, the average cost of an injector for Medicare patients was nearly $4,100. The cost for patients who pay in cash or are covered under private insurance is similar, but they make up only a fraction of Evzio sales as most insurers refuse to pay for the injectors.  As a result, Medicare and Medicaid payments account for an oversized portion of Kaleo’s revenue.

The company claims Evzio has saved over 5,500 lives since it was introduced and that “we have never turned an annual profit on the sale of Evzio.”

Naloxone has rapidly gone mainstream in recent years as public health officials and politicians have reacted to the opioid crisis by spending billions of dollars on addiction treatment and overdose prevention. Naloxone rescue kits are now routinely carried by police, firefighters and paramedics or given to heroin and opioid addicts to keep at home.

Naloxone is not usually prescribed to patients taking opioids for pain relief, although a 2016 study suggested it should be. The CDC opioid guideline also encourages physicians to prescribe naloxone to pain patients – even those on relatively modest doses.

“Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, or higher opioid dosages (≥50 MME), are present,” the guideline states.

Over the years, Kaleo has donated hundreds of thousands of free Evzio injectors to first responders, schools, hospitals and addiction treatment clinics. STAT News has reported that the naloxone in many of the injectors was just months away from expiring.

According to ProPublica, in 2016 Kaleo paid nearly $950,000 to pain management doctors and addiction treatment specialists for consulting, promotional speaking, travel, lodging, and food and beverage expenses.  

Learning to Cope With Loss

By Mia Maysack, PNN Columnist

There has never been an employment situation that has not been impacted by my chronic migraines, fibromyalgia and other health conditions. I'm a worker bee but pushing myself too hard for too long while trying to keep up has resulted in my inability to pursue aspirations that are not physically feasible.

The realization of not being able to live up to who you feel like you are is a tough one. A person cannot refrain from asking: What is wrong with me?

All the while, outsiders ask the same question, most with a hinge of disbelief pertaining to "invisible illness."

She looks and seems fine. Is anything really wrong with her?

In that regard, I've chosen to no longer stress over occasionally needing to wear my sunglasses indoors.

At least people can see those!

It can be a difficult concept to understand, how someone can seem fine one day, then be bedridden for the duration of any given week. Things we may have been able to do, even just the day before, vary moment by moment.

I’ve sensed an undertone of judgement regarding what taking proper care of myself looks like. A few examples of what I mean: 

“Must be nice to lie around in bed all day!”

“You’re still sick?”

“I have headaches too, but still manage to….”

In an effort to alleviate the pressure of these expectations, I've gotten to the point that I do my absolute best to avoid making commitments or plans. I only make them with those who understand my need for sudden disappearances, last minute cancellations, awkward positioning and random yoga stretches.

One of the greatest gifts I've ever given myself is taking good care of and putting myself first. Despite what seems to be a popular belief, that doesn’t mean trips to a day spa or an exotic beachfront. Pursuing self-care for me is the difference between being somewhat functional or a dungeon dweller.

Every time my health interferes with whatever I had my sights on, it’s like ripping gauze off a wound that’s not yet healed. It reopens its own spectrum of painful emotions, often leading to guilt over missing out and all those our absence is impacting. It’s a double-edged sword in a battle I seemingly cannot win.

It can be frustrating, but inward compassion is imperative. Think of it this way: When we know someone we care about is feeling unwell, what do we do? We offer support, advise them to rest, take the time they need, and do whatever is necessary for the sake of their health and healing.

We as chronic pain warriors deserve the same compassion, empathy, respect and self-care. I've learned over the years that forgiveness, patience and grace for ourselves is just as important as having that capacity for others.  

My experience has mostly been a lonesome one. Never once have I had a medical professional ask me how I am coping with these heavy burdens that are anticipated to be lifelong. I have still not been able to fully comprehend the gravity of what that diagnosis means.

It has been an excruciating process to get to where I am now. There's no guide book for this stuff, we gotta just keep trying until we find a way to make all of this serve us -- as opposed to the other way around.

I prefer now to find the positive in changes as they come, not worry about them until they do, and neglect the urge to over-analyze them long after they've arrived.  For me, it’s all about finding the joy, beauty and blessings in the given. There is always something to be appreciated and admired.

We must remain true to ourselves, even through and despite the turmoil of chronic pain. It may not reflect the vision we once had, but there’s no need to look back.  We are not headed in that direction anymore.  

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

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 FDA ‘Shadow Ban’ Causing Kratom Shortages?

By Pat Anson, PNN Editor

The American Kratom Association (AKA), an advocacy group for kratom vendors and consumers, came out with an alarming bulletin this week.

“BREAKING: FDA Commissioner Scott Gottlieb is shutting down kratom supplies shipments to the United States. The AKA is running out of time and resources to make sure we can secure the supply chain for you to purchase kratom,” read the post on the AKA’s Facebook page.

The bulletin claimed the FDA was trying to “criminalize kratom users” and then launched into a fundraising appeal asking supporters to “dig deep and send a contribution right now” to the AKA to support its lobbying efforts.

At best, the AKA’s bulletin was premature. At worst, it was misleading. Gottlieb is certainly no friend of kratom, but he’s not issued orders shutting down imports of kratom, an herbal supplement long used as a stimulant and pain reliever in southeast Asia.

The FDA declared an “import alert” for kratom in 2012 and again in 2014 – long before Gottlieb became commissioner – authorizing the seizure of dietary supplements containing kratom. Several large shipments were confiscated as a result of the alert, but clandestine imports of kratom into the U.S. continued largely unchecked.

Kratom has since become widely available online and in many smoke shops, and millions of Americans have discovered kratom can be used to self-treat their chronic pain, anxiety, depression and addiction.

AKA president Dave Herman told PNN the bulletin was based largely on anecdotal reports from a handful of vendors who had kratom shipments confiscated in recent months.  

“I’m sure some of them don’t want to talk about it, but I’ve talked to at least four or five that said their stuff has been grabbed,” Herman said. “I know of one vendor that had a hundred tons literally confiscated.

“We feel from day one that commissioner Gottlieb has been running a shadow ban. It’s clearly an attempt to ban and they’re using any and all portals to do that. But can I hand you a piece of paper (from FDA) that says, ‘We’re doing it?’ No.”

Herman said some kratom vendors are down to a few weeks supply.  

“There’s a lot of fear about what’s going on out there,” he said.

Kratom Demonized

Inflammatory rhetoric and scare tactics have become increasingly common in the escalating debate over kratom.

Gottlieb publicly calls kratom an “opioid” – even though its active ingredients are alkaloids -- while claiming there is “no evidence to indicate that kratom is safe or effective for any medical use.” Last year, the FDA claimed dozens of fatal overdoses were associated with kratom, while admitting nearly all of the deaths involved other drugs and “could not be fully assessed.”

Several kratom products were recalled earlier this year during an FDA and CDC investigation of a small salmonella outbreak associated with the herb. Although the source of the outbreak was never identified and only about 200 people were sickened, Gottlieb said “anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella.”

More recently, Ohio health officials have claimed kratom produces a “heroin-like high” and was being used intravenously by drug addicts – a notion that most kratom users found preposterous.

“Who the hell is injecting kratom? These people are out of their minds,” one reader told us.

The FDA did not directly respond to a request for comment on the AKA’s bulletin, only saying that “certain kratom products and importers” were targeted in its 2012 import alert. But Herman says it is clear to him what’s happening in 2018. “It’s a full demonization. I don’t think there is any doubt about that,” he said.

Herman believes federal health officials may be trying to avoid scheduling kratom as a controlled substance, something the DEA tried and failed to do in 2016 after a public outcry.  Scheduling kratom would require a public comment period and likely get Congress involved, which the FDA can avoid with a “shadow ban.”

“It’s a concerted effort. There is a (kratom) shortage out there. The shortage didn’t exist previously,” Herman said. “The range I’ve heard of any (vendor) inventory is the highest is 6 months and the lowest is two weeks. There’s definitely a movement there and its harder and harder to get the product into the country.”

When asked if the AKA bulletin could incite fear and lead to hoarding and price increases, Herman was circumspect.

“Some people will stock up. Some won’t,” he said. “How people react, I can’t anticipate. I don’t know the answer to that. I do know that’s there’s a shortage of product. And I think prices have already risen, best as I can tell.”   

Lightening the Load Over the Holidays

By Carol Levy, PNN Columnist

There was a train full of sewage traveling through Alabama. One town found the smell so horrid, likening the stench to “rancid meat” or worse, that they refused permission for the train to enter the town or even stop to transfer loads.

Another town welcomed the train. “Let it come. The smell can't be as bad as they say. They're exaggerating,” they said.

But then the train arrived. The second town found the stench to be as utterly revolting and repulsive as the first town had said. The second town had to experience it firsthand before they would believe a train could emit such noxious smells.

Sound familiar? I’ve always felt that those of us with chronic pain are singled out in a similar way, when we are disbelieved and told the pain "is all in your head.”

But if it can happen when people have a freight train full of sewage in their backyard, and even they are not believed, it gives me hope. Maybe we are not so different after all.

What does this have to do with the holidays, you ask?

When I heard about the train and the reaction to it, it started me thinking. The holidays are fast approaching and so are all the dinners and social gatherings that come with them.

I see the worries starting as I read posts on Facebook and elsewhere. Will I be able to do whatever they ask me to do? Will I have the energy to stay and make small talk and play with the kids? Will my family and friends accept me as I am, respecting my limitations and boundaries?

We can only answer those questions in the theoretical. We don’t know what the reality will be, how we will be, and how others will be when the holidays arrive.

Maybe now is the time to prepare ourselves. To realize some people will be respectful, helpful, compassionate and empathetic; while others will turn their backs on our needs and us. We often already know who will do what. We know who thinks, “It's not so bad. You're exaggerating.”

And like the first town with the sewage train, the residents' lives brightened and the stench dissipated when they got rid of the train. That is the thing about visiting. You know you can leave.

As the holidays approach, it is important that we allow ourselves the freedom to accept the caring folk, as well as the uncaring; the kind as well as the nasty; and the helpful as well as the hurtful.

And, most important of all, we must accept ourselves and all that we are.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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.

AMA: ‘Inappropriate Use’ of CDC Guideline Should Stop

By Pat Anson, PNN Editor

Two and a half years after the release of the CDC’s opioid prescribing guideline, the American Medical Association has finally taken a stand against the “misapplication” and “inappropriate use” of the guideline by insurers, pharmacists, federal regulators and state governments.

Although the guideline is voluntary and only intended for primary care physicians treating non-cancer pain, many pain patients have been forcibly tapered to lower doses, cutoff entirely or even abandoned by their doctors – all under the guise of preventing addiction and overdoses. The CDC has stood by and done nothing to correct the false portrayal of its guideline by insurance companies and pharmacies such as CVS.

The genie may be out of the bottle, but the AMA is now trying put it back in.

At its interim meeting in Maryland this week, the AMA House of Delegates adopted a series of resolutions that call for restraint in implementing the CDC guideline – particularly as it applies to the agency’s maximum recommend dose of 90mg MME (morphine equivalent units).

RESOLVED that our AMA affirms that some patients with acute or chronic pain can benefit from taking opioids at greater dosages than recommended by the CDC Guidelines for Prescribing Opioids for chronic pain and that such care may be medically necessary and appropriate.

RESOLVED that our AMA advocate against the misapplication of the CDC Guidelines for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit access to opioid analgesia.

RESOLVED that our AMA advocate that no entity should use MME thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guidelines for Prescribing Opioids.

“I was gratified to see these resolutions from AMA. This problem has been developing for some time, but really seems to have picked up steam over the past year, especially with respect to limits placed by pharmacy chains and insurers,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“It would have been good to see this kind of statement when various entities first began misinterpreting and misapplying the CDC guideline, but I also understand the need to ensure that a problem develops before proposing a solution.”

“Great to see the AMA is finally stepping up to help bring common sense to the ill-conceived and frankly very harmful CDC guideline,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “Unfortunately too many people have already been a victim of CDC’s misguided attempt to address the opioid problem.” 

Guideline Not Mandatory

Missing from the resolutions is any recognition by the AMA that many of its own members – the organization represents over 200,000 physicians – have been lying to their patients or remain wilfully ignorant about the voluntary nature of the CDC guideline.  

“Earlier this year my doctor explained that he was required to reduce my pain medications. I was shocked. He explained that new opioid prescribing guidelines were requiring patients to be reduced across the board, regardless of their condition,” pain patient Liz Ott wrote in a recent guest column. 

“My current doctor is currently weaning me off the last of my opioids, stripping me of the last tiny bit of medication that have any effect on my pain,” wrote Michael Emelio in another guest column. “After talking to half a dozen pain management doctors this year, I believe that they have been so programmed by the anti-opioid propaganda that many believe they're doing the right thing and fail to realize the true extent of the suffering they have caused.”

“A pharmacist decided to cut my opioid medication in half without permission from me or my doctor. It took 3 months to fix this and find a pharmacy to fill my medication,” wrote Deann Goudy in her guest column.

Even the AMA’s president had a patient – a man with advanced prostate cancer – who couldn’t get an opioid prescription filled by a suspicious pharmacist.

“The pharmacist suspected my patient was a drug seeker and did not alert me that his prescription was denied. My patient, a very proud man, felt shamed and didn’t know what to do. So, he went home to be as tough as he felt he could be. That worked for about three days and then he tried to kill himself,” Barbara McAneny, MD, said in a speech this week at the AMA meeting.

“My patient suffered, in part, because of the crackdown on opioids… When I visited my patient in the hospital as he was recovering from his suicide attempt, I apologized for not knowing his medication was denied. I felt I had failed him.”

The AMA has failed pain patients in the past. In 2016, just months after the release of the CDC guideline,  the AMA House of Delegates recommended that pain be removed as a “fifth vital sign” in professional medical standards – a move that pain management experts warned against because it could lead to delays in getting a diagnosis and treatment.  

AMA delegates that year also passed a resolution urging The Joint Commission to stop requiring hospitals to ask patients about the quality of their pain care. Medicare has a funding formula that requires hospitals to prove they provide good care through patient satisfaction surveys, but critics contended that questions about pain promoted opioid prescribing. They offered no credible evidence to support their claims, but the pain questions were soon dropped from patient satisfaction surveys.

Is Pain a Self-Fulfilling Prophecy?

By Pat Anson, PNN Editor

Getting out of bed, taking a shower, doing the dishes and other simple chores can be painful experiences for someone with intractable chronic pain. But some of that pain may be self-fulfilling: Getting out of bed hurts because you expect it to.

That's the theory behind a new brain imaging study published in the journal Nature Human Behaviour, which found that false expectations about pain can persist even when reality demonstrates otherwise.

"We discovered that there is a positive feedback loop between expectation and pain," said senior author Tor Wager, PhD, a professor of psychology and neuroscience at the University of Colorado Boulder.

"The more pain you expect, the stronger your brain responds to the pain. The stronger your brain responds to the pain, the more you expect."

Wager and his colleagues recruited 34 people for a heat test to see if the expectation of pain can cause changes in neural mechanisms of the brain.

Participants were taught to associate one symbol with low heat and another with painful heat. Then, the subjects were placed in a functional magnetic resonance imaging (fMRI) machine, which measures blood flow in the brain as a proxy for neural activity.

For 60 minutes, subjects were shown the low or high pain cues (the symbols “Low” and “High” or the letters L and W), and then asked to rate how much acute pain they experienced as heat was applied to their forearms or legs. Unbeknownst to the participants, heat intensity was not actually related to the preceding cue.

The study found that when subjects expected more heat, brain regions involved in threat and fear were more active as they waited for the heat to be applied. Regions involved in the generation of pain were also more active when they received the stimulus.

The result? Participants reported more pain with high-pain cues, regardless of how much heat they actually got.

"This suggests that expectations had a rather deep effect, influencing how the brain processes pain," said lead author Marieke Jepma, PhD, a researcher in Wager's lab who is now a researcher at Leiden University in the Netherlands.

Many subjects also demonstrated a high degree of confirmation bias -- a tendency to learn from things that reinforced their beliefs, while discounting those that didn’t. If they expected high pain and got it, they might expect even more pain the next time. But if they expected high pain and didn't get it, nothing changed.

"You would assume that if you expected high pain and got very little you would know better the next time. But interestingly, they failed to learn," said Wager.

Researchers say the study was the first to demonstrate the dynamics of a feedback loop between pain expectations and neural mechanisms that cause pain. Although the test only involved short-term acute pain, researchers say the findings may help explain why chronic pain can linger long after damaged tissues have healed.

"Our results suggest that negative expectations about pain or treatment outcomes may in some situations interfere with optimal recovery, both by enhancing perceived pain and by preventing people from noticing that they are getting better," said Jepma. "Just realizing that things may not be as bad as you think may help you to revise your expectation and, in doing so, alter your experience.”

New Cannabis Studies for Pain Management Underway

By Roger Chriss, PNN Columnist

Clinical trials of cannabis are quickly ramping up. Legalization of cannabis in Canada is leading to new studies of cannabis for pain management. And the recent legalization of medical cannabis in Utah and Missouri underscores the growing consumer and commercial interest in cannabis and the need for proper clinical research.

The National Academies of Science last year released a report stating that cannabis can be effective for managing some forms of chronic pain. But the report also acknowledged there is a limited evidence base to support the use of cannabis in pain management.

So, while it is trite to observe that enthusiasm for cannabis may be running ahead of science, it is important to note how quickly this is changing. We will soon know more about what cannabis is useful for medically, as well as when and how to use it clinically.

For instance, a new clinical trial is getting underway in Canada to look at inhaled cannabis versus fentanyl buccal (sublingual) tablets for managing pain in cancer patients.

This is a Phase II trial with two goals. First, an open-label randomized study to evaluate the effects of cannabis versus fentanyl in adults with breakthrough cancer pain who are already on opioids. Second, a randomized double-blind placebo-controlled trial to evaluate the effect of cannabis or fentanyl as compared to a placebo group with breakthrough cancer pain.

“Medical cannabis may help reduce the use of drugs like fentanyl for treating breakthrough and chronic pain,” said Dr. Guy Chamberland, CEO of Tetra Bio-Pharma, which is running the trial. “However, unrefuted scientific data on its safety and effectiveness that will satisfy regulators, professional groups and insurers is what’s missing.”

This will be the first trial to compare cannabis and opioids in a head-on fashion. Though it is specific to breakthrough cancer pain, it may provide insight into what the strengths and limitations of cannabis are in other types of pain management.

Another trial is looking at CBD oil for managing chronic non-cancer pain. It is sponsored by Hamilton Health Sciences Corporation and the Michael G. DeGroote Institute for Pain Research and Care at McMaster University in Canada. This is also a Phase II trial that seeks to determine whether CBD alone or a combination of CBD and THC reduces the pain of patients with chronic non-cancer pain. The trial will assess pain reduction and associated symptoms, as well as reductions in the use of other medications.

According to the trial protocol, participants will be randomly selected to receive up to 80mg of CBD in capsules for 12 weeks. The doses are many times greater than the commercial CBD oils, edibles and other products that are available over-the-counter, so this trial should help clarify how much CBD is needed to treat pain.

Research is underway in the United States as well, in particular at places like the UCLA Cannabis Research Initiative and at Washington State University. The results of these and other trials will enable sound clinical decisions for cannabis in pain management. At present, a lack of information hampers clinicians.

This was demonstrated in a recent article in The New England Journal of Medicine that looked at the pros and cons of using medical cannabis to treat a woman with Complex Regional Pain Syndrome.  Even the doctor who wrote in favor of cannabis admitted “high-quality evidence is limited” on its effectiveness as a pain reliever, although experiments on animals “provide reassuring support on safety.”

The studies now underway will better inform doctors about such decisions and reduce uncertainty.

Cannabis deserves good science. The changing legal landscape in Canada and the United States is providing research opportunities that will help clarify what cannabis may be useful for and how best to use it.

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.

Will Christie or Bondi Be Next Attorney General?

By Pat Anson, PNN Editor

PNN readers cheered last week when Attorney General Jeff Sessions was fired by President Donald Trump. Sessions angered many in the pain community when he called for further cuts in opioid production and said pain patients should “tough it out” by taking aspirin.  

“The good news is Jeff Sessions (was) forced to resign,” wrote Carole Attisano. “Finally getting a small bit of Karma you so well deserved,”

“Now let’s hope that we get somebody with some type of human conscience for those who suffer with pain,” wrote another PNN reader.

As the saying goes… be careful what you wish for.

According to CBS News, two of the early front runners to be nominated as the next Attorney General are former New Jersey Gov. Chris Christie and Florida Attorney General Pam Bondi. Like Sessions, both have been longtime critics of opioid prescribing and served last year on President Trump’s opioid commission.

CHRIS CHRISTIE

Christie certainly has experience in law enforcement. He was a federal prosecutor and U.S. Attorney in New Jersey from 2002 to 2008.

As governor, Christie signed legislation that made New Jersey one of the first states to limit the supply of opioids for short-term, acute pain. He also bitterly opposed efforts to expand the use of medical marijuana, calling cannabis activists “crazy liberals” willing to “poison our kids” for marijuana tax revenue.   

The final report from the president’s opioid commission, which Christie chaired, took a law-and-order approach to the opioid crisis, calling for “involuntary changes” in opioid prescribing.

“This crisis can be fought with effective medical education, voluntary or involuntary changes in prescribing practices, and a strong regulatory and enforcement environment,” the commission said.

In its five public hearings, the commission heard testimony from addiction treatment activists and several people who lost loved ones to opioid overdoses. But the panel never asked for or received testimony from pain sufferers, patient advocates or pain management physicians.

Pam Bondi did not have a prominent role on the opioid commission and only joined the panel in its final weeks. Her second and last term as Florida’s Attorney General ends in January. “She has not yet made a decision as to what she will do next,” a spokesman told CNN.

Bondi has a good relationship with President Trump and was once rumored to be the next head of the White House Office of National Drug Control Policy — also known as the nation’s “drug czar.”

Bondi played a prominent in shutting down Florida’s pill mills, but critics say she has been slow to acknowledge that the opioid crisis has shifted away from prescription painkillers to heroin and illicit fentanyl.

“The problem is Bondi isn't doing enough about the heroin epidemic,” the Miami Sun Sentinel said in a 2017 editorial. “Considering that Bondi was once touted as a potential Trump drug czar — and infamously failed to investigate Trump University after receiving a major donation from Trump — it's no surprise that she was named to the commission. But she's still living off her reputation from the pill mill crack down.”

PAM BONDI

Christie also has a good relationship with the President Trump, but has urged that there be no interference with special counsel Robert Mueller’s investigation – a potential stumbling block with the president. Like Sessions, Christie could also face calls to recuse himself from the investigation because he chaired Trump’s transition team.

According to CNN, other potential contenders for Attorney General are Solicitor General Noel Francisco, Rep. John Ratcliffe, (R) Texas, former Judge John Michael Luttig, Judge Edith Jones, former Judge Janice Rogers Brown, retiring Rep. Trey Gowdy, (R) South Carolina, and Sen. Lindsey Graham, (R) South Carolina.

Matthew Whitaker, the current acting Attorney General, can serve in that temporary position for 210 days under federal law.

AMA: Patients Being Harmed by Rx Opioid Crackdown

By Pat Anson, PNN Editor

Patients are being harmed by the crackdown on opioid pain medication and increasingly “burdensome” requirements for prior authorization, according to the president of the American Medical Association.

“The pendulum swung too far when pain was designated a vital sign, and now we are in danger of it swinging back so far that patients are being harmed. We need to use our expertise in patient care to change the dialogue to appropriate pain control,” said Barbara McAneny, MD, at a weekend meeting of the AMA. 

McAneny, who is a practicing oncologist in Gallup, New Mexico, shared the story of a patient with advanced prostate cancer who was in severe pain.  

“Metastatic prostate cancer in your bones hurts, and one day he called me to say that his pain regimen wasn’t holding him. So, I increased the dosage of his opioids from two per day to three and of course he ran out early,” McAneny said. “So, I called his primary care physician who agreed to write a prescription for his very large amount of time-release morphine.” 

When the patient tried to get his prescription filled, the pharmacist called the insurer for prior authorization and was denied. The pharmacist also checked the prescription drug monitoring program (PDMP) and found that the patient had multiple prescriptions written by McAneny and other doctors.  

BARBARA MCANENY, MD (AMA PHOTO)

“The pharmacist suspected my patient was a drug seeker and did not alert me that his prescription was denied. My patient, a very proud man, felt shamed and didn’t know what to do. So, he went home to be as tough as he felt he could be. That worked for about three days and then he tried to kill himself,” said McAneny.  

“Fortunately, his family found him in time, and the emergency medicine physician was able to save his life. He spent a week in the hospital and finally we got his pain back under control, on the exact regimen I had prescribed him as an outpatient.”  

Ironically, the insurer paid for the patient’s ambulance and hospital bills without any prior authorization. And the CDC’s “voluntary” opioid guidelines — which have been widely adopted by insurers — don’t even apply to cancer patients.

“Like you, I share the nation’s concern that more than 100 people a day die of an overdose. But my patient nearly died of an under-dose. This story illustrates the problems we all confront every day in our current dysfunctional health care system,” McAneny said. “The health plan does not have the chart, doesn’t know the patient, and basically countermanded my orders without even telling me using the prior authorization process. How have we let health plans determine the course of care? They call this quality? 

“My patient suffered, in part, because of the crackdown on opioids… When I visited my patient in the hospital as he was recovering from his suicide attempt, I apologized for not knowing his medication was denied. I felt I had failed him.”

McAneny cited a 2017 AMA survey, which found over 90% of doctors believed prior authorization led to delays in treatment and had a negative impact on patient outcomes. Nearly a third of doctors had to wait at least 3 business days for a prior authorization decision to be made.  

New prior authorization rules to be adopted by Medicare on January 1 could lead to delays in treatment for millions of elderly and disabled pain patients on high doses of opioids. Prescriptions over 200mg MME (morphine equivalent daily doses) will trigger a “hard edit” safety alert requiring pharmacists to consult with the prescribing physician before filling a prescription. Insurers will also be given greater authority to identify beneficiaries at high risk of addiction and to require they use “only selected prescribers or pharmacies.”