Suspension of Dr. Ibsen's Medical License Reversed

By Pat Anson, Editor

A Montana district court judge has reversed the suspension of Dr. Mark Ibsen's medical license, ruling that the state medical board made numerous errors when it suspended Ibsen’s license in 2016 for allegedly overprescribing pain medication.

Judge James Reynolds said the Montana Medical Board violated Ibsen’s right to due process by failing to allow expert witnesses to testify in his defense during board hearings. The board also rejected the findings of its own hearing examiner, who said Ibsen’s standard of patient care was sufficient.

“It is analogous to the selection of a jury in a civil case and then when the verdict comes in against a party, that party asking for the selection of another jury. Except in this case, it is even more striking because it is the agency who selected the hearing examiner,” Judge Reynolds ruled.

“They screwed up,” Ibsen attorney John Doubek told the Independent Record. “I think it’s a pretty sharp rebuke to a decision that was totally off-base.

“The sad thing is my client has been under their thumb now for two years. He can’t move his practice because he has this black mark against his reputation and against his license, so he’s been unable to practice medicine and this guy is a good doctor.”

DR. MARK IBSEN

Ibsen first came under investigation in 2013, when he was accused of over-prescribing opioid medication by a disgruntled former employee at his Helena medical clinic.

“I’m a little stunned that it happened,” Ibsen said of the judge’s decision. “I’m mostly angry. It could have been resolved in 10 minutes, instead of five years.”  

Although the suspension of Ibsen’s license was stayed while he appealed the board’s ruling, his professional reputation was so damaged that pharmacists refused to fill his prescriptions and he was forced to close his clinic. Ibsen’s former patients also suffered. He says three committed suicide (including the recent death of Jennifer Adams) and three others died of causes likely related to the stress of their pain not being treated. Montana has the highest suicide rate in the country.

Ibsen told PNN that Montana has become a virtual “wasteland” for pain care, because many of the state’s doctors fear being prosecuted or losing their licenses for prescribing opioids.  Several of Ibsen's patients were former patients of Dr. Chris Christensen, a Ravalli county physician convicted of negligent homicide after two of his patients died from overdoses.

“There was a clear time there I was crying for help. I was just inundated by these pain patients that my colleagues weren’t dealing with. And I was just sort of shocked at the cruelty of the way I was treated and the cruelty of the way pain patients were being treated,” he said. “I’ve got a lot of compassion for people who don’t feel like they belong in the medical model. I’ve been shunned. They’ve been shunned.”

And after five years of legal battles, the only drug Ibsen will prescribe now is medical marijuana.

“It terrifies me to consider opening up a clinic again. They might come after me,” Ibsen said. “Things could change, but I have nothing in the on-deck circle.  I don’t have anything planned. It was just not good for me to plan anything.”

Did 70,000 Opioid Deaths Go Uncounted?

Pat Anson, Editor

The nation’s overdose epidemic may be worse than it appears, according to a new study that estimates as many as 70,000 opioid-related overdose deaths since 1999 were not included in mortality figures because of incomplete reporting.

The study, which does not distinguish between deaths involving prescription opioids and those linked to illegal opioids such as heroin, adds to growing evidence that the government's overdose statistics are unreliable.

Researchers at the University of Pittsburgh Graduate School of Public Health analyzed death certificate data from 1999 to 2015 and found that coroners and medical examiners in many states often did not specify the drug that contributed to the cause of death.  

“Coroners are less likely than medical examiners to be physicians and do not necessarily have the medical training needed to complete drug information for death certificates based on toxicology reports,” said lead author Jeanine Buchanich, PhD, who reported the findings in Public Health Reports, the official journal of the Office of the U.S. Surgeon General.

"Incomplete death certificate reporting hampers the efforts of lawmakers, treatment specialists and public health officials. And the large differences we found between states in the completeness of opioid-related overdose mortality reporting makes it more difficult to identify geographic regions most at risk."

The variability among states was significant - ranging from fewer than 10 unspecified overdose deaths in Vermont to 11,152 in Pennsylvania. States with a decentralized county coroner system or a hybrid system that uses both coroners and medical examiners were more likely to have a high proportion of unspecified overdose deaths.

Overdose deaths are assigned specific "T codes" for each drug found by the coroner or medical examiner. Deaths that can’t be attributed to a specific drug are given the T-code of T50.9 – which means "unspecified drugs, medicaments and biological substances."

Researchers say the widespread use of that code underestimates the actual number of opioid-related deaths. In five states - Alabama, Indiana, Louisiana, Mississippi and Pennsylvania - more than 35 percent of the overdose deaths were coded as unspecified.

“Our analyses indicated that potentially more than 70,000 unspecified, unintentional overdose deaths in the past 17 years, including more than 5,600 in 2015, could be categorized as opioid-related unintentional overdose deaths,” said Buchanich.

Questionable Overdose Data

Last year President Trump’s opioid commission urged the federal government to work with states to improve the toxicology data on overdose deaths by developing uniform forensic drug testing.

“We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the commission said in its final report.

Critics also say the overdose data reported by the CDC and other federal agencies is often flawed or cherry-picked. CDC recently researchers admitted that many overdoses involving illicit fentanyl and other synthetic black market opioids were erroneously counted as prescription opioid deaths. Toxicology tests cannot distinguish between pharmaceutical fentanyl and illicit fentanyl

The overdoses data is further muddied because multiple drugs are involved in almost half of all drug overdoses. And there is no way to distinguish between deaths caused by legitimate opioid prescriptions and those caused by diverted prescriptions or counterfeit drugs.

A recent report from the Substance Abuse and Mental Health Services Administration found that drugs used to treat depression, anxiety and other mental health conditions are now involved in more overdoses than opioid pain medication.

The CDC estimates that 63,632 Americans died from drug overdoses in 2016 – a 21.5% increase over the 2015 total.  

My Opioid Dependency Turned into Addiction

By Jim Best, Guest Columnist

When I was in my early 40’s, I had an accident at work that injured the discs in my lower back. I tried physical therapy, but after three months of little improvement they performed a discectomy.

The surgery was successful and I had very little pain until a year later, when I re-injured the same area. I was taken to the hospital in an ambulance and a neurosurgeon decided I needed emergency surgery and performed a laminectomy. This time, the pain came back after less than six months. I was in constant pain (most days rated somewhere between a 6-8) and unable to work. 

The next ten years included numerous trips to various providers, including pain specialists. I was evaluated by orthopedists and neurologists, and informed I was not a good candidate for spinal fusion surgery due to my overall body structure. They took more than a dozen MRI’s and I was subject to painful spinal injections on a regular basis.

I was also given a discogram, which is an extremely painful diagnostic procedure involving the insertion of needles into the spinal discs. The pain was so severe from this procedure that I passed out. The results were “inconclusive.”

During those ten years I was also introduced to opiate medication. They started me off on Vicodin and I was eventually prescribed OxyContin by my regular doctor. I took relatively small doses to start, but it didn’t take too long before I was being prescribed larger and larger doses.

What I didn’t know was that the more I took, the more I thought I needed. This is known as opioid-induced hyperalgesia, a syndrome in which people can become hypersensitive to painful stimuli due to prolonged use of opioids.

Although at the time I was sure that had nothing to do with my case, now I see where it made perfect sense and I should have ceased my opiate use immediately. However, I continued to use for five additional years. 

JIM BEST

An important part of my story concerns my addiction to alcohol, which I stopped using in 2005. I was a stalwart member of AA up until 2015, when I had a relapse. I never really discussed my use of painkillers with other people because I was afraid they would think I might have a problem with pills. Of course, they would have been correct, but I fooled myself into thinking I was okay.

That is part of the self-delusion of any kind of drug use, but perhaps more so with opiates because they were prescribed by a doctor and because I felt I had a legitimate reason for using them -- a rationalization I maintained even when I was using far more than prescribed.

Looking back, I do not believe I should have ever been prescribed opioid medication due to my addictive personality. I don’t blame the doctor who prescribed them to me. I would tell her horrible stories of not being able to get out of bed without the pills, or how some days all I could do was sit in a chair and cry. I believe that as a physician (as well as a caring and compassionate human being), she was concerned with my pain and truly thought she was doing what was in my best interest.   

It’s important to make one fact clear: I was in pain. Although I certainly hyperbolized my symptoms to my doctor, girlfriend and a few others, I did have daily chronic pain. And I was dependent on the drugs to provide some modicum of relief.

There came a time, however, when the dependency turned into an addiction. I literally could not function without large doses of the drugs. I also began to abuse them by taking more than prescribed and taking them in non-prescribed methods such as snorting.

The end of my use came when I got busted by my doctor. She caught me in one of the myriad of lies I had to tell because I would run out of pills before the next prescription was due. She gave me a script for 10 Xanax and basically told me good luck.

I went through withdrawal for a few days and then, after almost ten years of sobriety, I started to drink again. Eventually, I ended up in treatment. I admitted to the counselors at the treatment center that opioids were also “sort of a problem.” Luckily, they saw through the lie and I was put on Suboxone. I still take the Subs because they help with the pain and I don’t have the urge to use anymore.

I still experience daily pain. Some days it is bad enough that I have to be very careful with how much I exert myself. But I manage to get by without the pills.

As an aside, I feel like the current restrictions being put on opioid medications are too extreme. Not everyone that takes them has a problem and by restricting them, as many states currently are, they are making life very difficult for the ones using them responsibly.

What other people do is their business. For myself, taking such medications is no longer an option. I hope this story helps someone. 

Jim Best lives in Minnesota.

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.

Did Chronic Pain Patients Help Elect President Trump?

By Pat Anson, Editor

Rates of opioid prescribing were significantly higher in counties that voted for Donald Trump in the 2016 presidential election, according to a new analysis published in JAMA Network Open.

Researchers at the University of Texas compared voting trends, census information and Medicare data for people who received opioid prescriptions for 90 days or more. Nearly 60 percent of U.S. counties that voted for Trump had an above average opioid prescribing rate in 2015. Counties with below average prescribing rates voted for Trump only 39 percent of the time.

The researchers cautioned that the study does not mean that chronic pain patients were more likely to vote for Trump. It’s more likely to indicate that economic, health and social problems that lead to opioid use – sometimes called the "epidemic of despair" -- played a role in Trump’s victory.

“Support for the Republican candidate in the 2016 election is a marker for physical conditions, economic circumstances, and cultural forces associated with opioid use,” wrote lead author Dr. James Goodwin, chair of geriatric medicine at the UT Medical Branch in Galveston. “This association is related to underlying county socioeconomic characteristics that are common to both chronic opioid use and voting patterns, particularly characteristics pertaining to income, disability, insurance coverage, and unemployment.”

The researchers created a map (above) showing counties with the highest rates of opioid prescribing in dark red, while a second map (below) shows counties that overwhelmingly voted for Trump in dark red. 

The maps have similarities, but they don’t align perfectly or prove a cause and effect relationship between prescribing and voting. For example, while Trump won unexpected victories in Michigan, Wisconsin and Pennsylvania, where opioid prescribing is high, he also won in North and South Dakota, where prescribing rates are relatively low. 

During the 2016 presidential campaign, Trump and Hillary Clinton both called for further restrictions on opioid prescriptions and expanded access to addiction treatment. Clinton also endorsed a proposed tax on opioid pain medication.

“Given that both candidates focused on opiate addiction as a major campaign issue, it is difficult to infer that opiate prescription rates are somehow linked with voting behavior based on the candidates’ respective campaign promises and/or platforms,” wrote James Rosenquist, MD, in an editorial also published in JAMA Open Network.

“These limitations aside, this article’s findings add to a growing body of literature showing the interrelationship between public health and society, including the all-important economic and political realms.”

The “epidemic of despair” was first documented by Princeton researchers Anne Case and Angus Deaton in 2015.  They believe that the reduced life expectancy of middle-aged white Americans is linked to substance abuse, unemployment, poor finances, lack of education, divorce, depression and loss of social connections.

"People who reach for an opioid might also reach for ... near-term fixes," Nancy Morden, PhD, a professor at the Dartmouth Institute for Health Policy and Clinical Practice, told NPR. "I think that Donald Trump's campaign was a promise for near-term relief."

A Third of Pain Patients Have Stopped Using Rx Opioids

By Pat Anson, Editor

Over a third of pain patients (34%) have stopped taking opioid medications because their doctor is no longer willing to prescribe them, according to a large new survey of American adults living with chronic pain.

Eight out of ten patients (84%) say there is an unfair stigma associated with chronic pain, and half said they have lied about or hidden their use of opioid painkillers from others.

“The rise of the opioid epidemic has had a significant impact on those living with chronic pain, and oftentimes the voice of this population has gotten lost. We wanted to shine some light on the experiences of chronic pain sufferers with this research,” said Shai Gozani, PhD, president and CEO of NeuroMetrix, which commissioned the survey.

NeuroMetrix is the creator of Quell, a wearable medical device that uses neurostimulation to relieve chronic pain. The company hired the market research firm of Vanson Bourne to interview 1,500 Americans aged 25 and older, who were suffering from chronic pain for at least three months. An equal number of men and women participated.

The interviews were conducted online in early 2018 -- two years after the Centers for Disease Control and Prevention released new guidelines that discourage the prescribing of opioids for chronic pain. Although voluntary and only intended for primary care physicians, the guidelines have been widely adopted by insurers, regulators and providers throughout  the U.S. healthcare system.

The survey found that most pain patients are cautious about their use of opioids. Sixty-one percent are worried about addiction, a little over half (51%) said they only take opioids when necessary, and 42% don't like their side effects.

The stigma associated with opioids impacts how some patients communicate with their doctors. One out of five (20%) downplay the level of their pain and 13% said they are more cautious when speaking with their doctor. Only 9% of patients said they emphasize their pain level.

Most patients want to try pain therapies besides opioids. Nine out of ten said they are actively looking for new treatment options and most had tried at least one alternative, non-pharmacological therapy.  

Most Widely Used Alternative Therapies

• 65% Physical therapy
• 65% Lotions, rubs and patches
• 44% Over-the-counter TENS
• 33% Doctor prescribed TENS
• 28% Yoga, pilates, meditation
• 21% Acupuncture
• 16% Medical marijuana
• 16% Cognitive behavioral therapy
• 15% Surgery, implantable devices

The two most common reasons for pain patients to seek alternative treatments is because they don't like the side effects of prescription drugs (43%) and they prefer to treat pain without medication (39%). A majority (59%) don't believe their doctor is completely informed of treatment options outside of prescription drugs.

“These results underscore the need for more research and treatment modalities to support those living with chronic pain, as well as a joint effort among care providers, innovators, government stakeholders and patients to expand the goals of pain treatment," said Gozani.

"If we shift focus to making the end goal of pain treatment about decreasing suffering and disability rather than exclusively pain intensity, we may open ourselves to new possibilities and treatments that will empower those with chronic pain to find relief and gain greater control over their lives.”

You can read the full report, “Flipping the Script: Living with Chronic Pain amid the Opioid Crisis” by clicking here.

I’m Ashamed of the U.S. Justice Department

By Drew Pavilonis, Guest Columnist

I was a federal law enforcement officer with the U.S. Department of Justice (DOJ) for 14 years. Hard work, a willingness to transfer, and a graduate degree brought fast promotions and a coveted position in management at a DOJ training academy just outside of Denver.

However, a rare type of brain tumor deep in the thalamus brought everything to a sudden halt after ten years in Denver. My doctors initially said the brain tumor was inoperable due to its sensitive location, but the tumor continued to grow, and I eventually flew to Phoenix to have a talented neurosurgeon perform the difficult surgery to remove it.

The thalamus and brainstem proved to be a very challenging surgery and I suffered permanent disability because of it. I spent several months as an inpatient at a neuro-rehabilitation hospital, relearning how to walk and speak, dress and bath myself.

The DOJ medically retired me because cripples can't be law enforcement officers. Fortunately, I had 19 years of federal service and was able to retire with a pension, which was a good thing since I was not able to work due to my significant disability. 

However, the suffering didn’t end there. I developed chronic, debilitating pain 3 years after the surgery.

DREW PAVILONIS

Fortunately, at the urging of my sister, I had moved close to Duke University Hospital in North Carolina for follow up medical care. The doctors at Duke hypothesized that my pain was due to scar tissue that formed in my thalamus after the brain surgery. The thalamus is the brain's pain center and my pain “switch” had been permanently turned on.

I was bedridden and prayed for death daily. The pain was so bad that I could not walk. I was taken by ambulance to Duke Hospital for a one week stay as an inpatient and was medically tested to the extreme. Eventually, the doctors determined that I had real pain and referred me to pain management. 

I was prescribed methadone, four times a day. Additionally, to fight the debilitating nerve pain that I also have, I was put on the maximum dose of gabapentin. The medications just allow me to live, much like diabetics need insulin to survive. I am always in pain, but the medications control it to a tolerable level.

I am able to travel internationally (I write this from my hotel room in Berlin, Germany), do volunteer work, and ride an outdoor wheelchair. However, I worry that that I will someday become collateral damage in this “war on opioids.”

I cringe every time I see a journalist cite the CDC report about opioid related deaths in America. That report was full of errors and incorrect by the CDC's own admission. Also concerning are the jack-booted tactics of the DEA, which attacks legitimate pain treatment as if doctors were responsible for all the heroin in the country.

Those rogue tactics have had a chilling effect on the practice of pain management and contributed to a growing number of patient suicides. Many chronic pain patients have taken their own lives because they could not get the appropriate medication that they so desperately need to live.

I never thought I would see human rights violations conducted by my own government against fellow Americans. It is unbelievable.  I no longer tell people that I am retired from the DOJ because I am ashamed of it. I just say that I’m retired from the federal government. That's sad.

Drew Pavilonis lives in North Carolina.

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.

Hydrocodone Rescheduling Fueled Online Drug Sales

By Pat Anson, Editor

Hydrocodone was once the most widely prescribed and one of the most abused drugs in the United States. Over 135 million prescriptions were filled in 2012 for hydrocodone combination products such as Vicodin, Lortab and Norco.

Then in 2014 the Drug Enforcement Administration rescheduled the opioid painkiller from a Schedule III controlled substance to the more restrictive category of Schedule II. The move was intended to reduce the prescribing of hydrocodone – and it quickly had the desired effect.  By 2017, only 81 million prescriptions for hydrocodone were filled.  

But while legal prescriptions for hydrocodone have gone down, the DEA’s 2014 rescheduling may have fueled a surge in illegal online sales of hydrocodone and other opioids, according to a new study in the British Medical Journal.    

“The scheduling change in hydrocodone combination products coincided with a statistically significant, sustained increase in illicit trading of opioids through online US cryptomarkets. These changes were not observed for other drug groups or in other countries,” wrote lead author Jack Cunliffe, PhD, a lecturer in data analysis and criminology at the University of Kent.

Cunliffe and his colleagues studied these online cryptomarkets – also known as the “dark web” – by using web crawling software that scans the internet looking for websites dedicated to online sales of illicit drugs. From October 2013 to July 2016, they found that sales of prescription opioids on the dark web nearly doubled, from 6.7% to 13.7% of all online drug sales.  

“Our results are consistent with the possibility that the schedule change might have directly contributed to the changes we observed in the supply of illicit opioids,” said Cunliffe. “One explanation is that cryptomarket vendors perceived an increase in demand and responded by placing more listings for prescription opioids and thereby increasing supply.”

‘Iron Law of Prohibition’

The increase in supply and demand wasn’t just for hydrocodone. The researchers also noted a growing number of online listings for more potent opioids, such as oxycodone and fentanyl. They attribute that to the “iron law of prohibition” – banning or reducing the supply of one drug encourages users to seek more potent drugs from new sources.

“We found that users were first buying oxycodone followed by fentanyl. Drug users adapt to their changing environment and are able to source drugs from new distribution channels if needed, even if that means by illegal means. In a context of high demand, supply side interventions are therefore likely to push opioid users towards illicit supplies, which may increase the harms associated with their drug use and make monitoring more difficult,” Cunliffe wrote.

As PNN has reported, business is booming for illegal online pharmacies. As many as 35,000 are in operation worldwide and about 20 new ones are launched every day. About half are selling counterfeit painkillers and other medications. Overdoses involving fentanyl and other synthetic opioids – most of them purchased on the black market – have also increased and now outnumber those linked to prescription opioids.

"The study’s findings are troubling but not surprising. As you’ve well reported, there are often unexpected and negative externalities resulting from well-intended anti-addiction interventions," Libby Baney, Principal, Faegre Baker Daniels Consulting and senior advisor to Alliance for Safe Online Pharmacies said in an email to PNN. 

"What’s worse still, when buying medicine online - whether from dark or surface web sellers - it is virtually impossible for the consumer to know if the product is what it claims (in this case, an opioid like oxycodone) or is a dangerous counterfeit laced with a deadly dose of elephant tranquilizer or poison. As too many victims have shown, even one pill can kill."

A recent study at the University of Texas Medical Branch also found an association between hydrocodone's rescheduling and increased opioid abuse.  Researchers found that hydrocodone prescriptions for Medicare patients declined after rescheduling, but opioid-related hospitalizations increased significantly for elderly patients who did not have a prescription for opioids.

The Other Victims of the Opioid Epidemic

By Katie Burge, Guest Columnist

Imagine the fear, frustration, helplessness and anger you might feel upon learning that your doctor cannot treat you to the best of his or her ability because they’re afraid of being arrested. 

I don't have to imagine that because I am a chronic pain patient with a degenerative spinal condition, plus severe osteoarthritis and fibromyalgia; each of which cause severe chronic pain 24/7. Combined, they can make simple tasks like getting dressed in the morning sheer torture.

Pain patients are the other victims of the so-called opioid epidemic, the ones the media usually don’t mention unless they're blaming us for other people's drug usage. 

Patients are being forced to live in agony and, as a result, increasingly lose their lives due to catastrophic medical events, such as stroke, heart attack and even suicide.

These can all be triggered by the physical, mental and emotional pressures of trying to survive with inadequately treated chronic pain.

Why?  Because politicians and bureaucrats (who refuse to admit the government is completely impotent at controlling the proliferation of illicit drugs) have managed to sell the public on the ridiculous premise that refusing medically necessary medication to one group of people will somehow alter the behavior of another group, and handily end America's drug crisis.

This approach simply does not work. Torturing vulnerable pain patients by refusing them life-giving medication will never make the slightest dent in the illegal drug trade because, sadly, people who want to get high will find something somewhere that will enable them to do so. 

Also, most of the prescription opioids that people abuse DO NOT come from doctors or pain patients. Less than one percent of legally prescribed opioid medication is diverted.  People in true pain are not going to suffer additionally by sharing or selling their medication. And doctors are not as careless with their prescription pads as the powers-that-be would like you to think.  

Nonetheless, the entities that control doctors’ licenses to prescribe opioids have yielded to political pressure by ordering doctors to either cut back on pain medication to the point that it's ineffective or stop opioid treatment altogether, regardless of patient need or outcome.

Inadequately treated chronic pain has stolen a great deal of my independence and quality of life, and though I hate the idea of taking pain medication at all, my greatest desire is to simply be able to fully participate in my own life again.  I will never be pain free, but I long to be able to play with my grandchildren, go to the theater or sit through an entire movie (and still be able to walk back to my car).

The mainstream media is also responsible for the ridiculous narrative that opioids have no legitimate clinical use and are immediately addictive. The result of this bias and hyperbole is that most folks believe outlawing the legitimate medical use of opioids can only be a good thing. Society teaches us that pain is somehow shameful.  We must “suffer in silence” and learn to control our pain without complaint or medical intervention. 

With such an abundance of myth and misinformation, it's no small wonder that actual facts about pain tend to get lost in the mix. Please allow me to share a few:

First, many overdose deaths are made to sound as though they were caused by a single prescription or even a single dose of opioids, when they are actually the result of a mixture of different medications, street drugs and alcohol. 

Second, chronic pain affects more Americans than heart disease, cancer and diabetes combined.  And studies have repeatedly shown that less than 4% of those who take opioid medication for pain become addicted.  They might develop a dependence or tolerance, but that occurs with many medications.

Physical “dependence” simply means that, if a drug or substance is stopped abruptly, the body will react by exhibiting withdrawal symptoms.  “Tolerance” occurs over time, as the dosage of some drugs might need to be adjusted as the body grows tolerant to its effects. Neither of these conditions is unique to opioids, nor are they necessarily indicative of addiction -- which is characterized by compulsive drug seeking behavior and use, despite harmful consequences.

Personally, I believe the question of addiction simply comes down to motive.  If your primary motive in taking opioids is to get high, you might be a drug addict.  If your only motive is pain relief and once that relief is achieved you do not increase the dose, you are not a drug addict.

Drug abuse is a complex social issue that has no easy fixes.  It should not, however, be confused with the medical management of chronic pain.  All life is precious and should be valued and protected, but not at the expense of others.

So, the next time your favorite TV show has a story line about someone going to the hospital and being transformed into a raving drug addict, or you hear yet another biased news story about opioids, do something about it.  You can help save lives by contacting the source of those fallacies and insisting that they tell the whole truth about the opioid crisis. Call them. Write a letter. Send an email.

We desperately need your voice, your prayers, your empathy and your compassion.

Katie Burge lives in south Mississippi, which she calls a “a veritable wasteland” for pain treatment. 

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.

Life After Pain Meds

By Dana Stephenson, Guest Columnist

It was a warm October afternoon in 1997 when my boyfriend called and asked if I wanted to go for a ride. Being from the northeast and motorcycle season was almost coming to an end, I said sure.

I often wonder how my life would have played out if I had just stayed home that day.

It started out as a normal ride with another friend, until the friend took off down a back road. Being just 18, my boyfriend took off after him. Long story short, the road turned and we did not. We slammed head-on into a telephone pole at 85 mph. The brakes on a motorcycle don't work so well when the wheels aren't touching the ground.

I was airlifted to a hospital and was in critical condition for several weeks. I spent 10 months in the hospital and had at least eight surgeries for a fractured spine and pelvic bone, pierced colon, and bruised heart, lungs and kidney. On the outside, I only had a few scratches but I was lucky to be alive at all, considering I wasn't wearing a helmet. 

Sadly, the worst was yet to come.  I kept asking the nurses, “Where’s Mike?” The nurses would act like they couldn't hear me. I understand now they were just doing their job, but at the time I thought I was going crazy.

Three days into my hospital stay, I asked my dad the same question. He gave a simple reply, four words that I'll never forget: "He didn't make it."

Not only was this my first experience with broken bones, surgery and stitches, it was also my first experience with death.

Pain medications were necessary, along with some counseling. I made it out of the wheelchair, off the walker, and then finally the crutches. The doctors called me a walking, talking miracle.

After a few years they transferred me to pain management and I slowly began developing a new problem. To people that didn't know my story, I appeared to be normal. Pharmacists always gave me the impression that they thought I was a drug addict. Why is this young, healthy-looking girl taking such high doses of painkillers? Over the years this began to bother me more and more.

Ten years after my accident, I finally decided to get a spinal fusion, hoping the pain would go away and the social judgement would finally stop. Well, that didn't go as planned. In the 10 years since my initial fracture, I had developed scoliosis. During surgery the doctor pulled so hard on my spine, trying to get it as straight as possible before screwing it in place, he ended up re-fracturing it. Now I was in worse shape than before. 

DANA STEPHENSON

Yet a new chapter of my life began. I had to accept that at age 29, I was going to have to file for disability. After a two-year struggle they approved my application, after first denying it because of my age. That's not even legal.

After 15 years of being in pain and treated like a junkie, I had enough. It was time to get off all pain medication. I went the Suboxone route and it definitely helped with the withdrawals. After a few years I quit that too.

Of course, I'm still in a lot of pain but taking the medications again is just not worth it to me. I moved away from home, so I wouldn’t be tempted to bum pills off my old connections.

I can honestly say I haven touched a pain pill in over 5 years. It's not easy, but I'm going to be in pain with or without the pills.

Dana Stephenson lives in Florida.

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.

Sessions: ‘Drug Overdoses Finally Started to Decline’

By Pat Anson, Editor

There are signs – very tentative signs –  that the U.S. is making progress in the so-called opioid epidemic. Attorney General Jeff Sessions alluded to some of them in a speech on Friday.  

“New CDC preliminary data show that last fall, drug overdoses finally started to decline.  Heroin overdose deaths declined steadily from June to October, as did overdose deaths from prescription opioids,” Sessions said at the Western Conservative Summit in Denver.

Overdoses from heroin and prescription opioids did indeed fall by about 4 percent during that five-month period, but what Sessions failed to mention is that deaths from illicit fentanyl and other synthetic opioids rose by 12 percent – more than making up for whatever gains were made in reducing deaths from heroin and painkillers. 

From October 2016 to October 2017, the CDC estimates that 68,400 Americans died from drug overdoses, a 12% increase from the previous 12-month period.

So overdoses have not “finally started to decline” as Sessions claims. And the Attorney General, who once urged chronic pain sufferers to take two aspirin and “tough it out,” continues to blame prescription opioids for much of the nation’s drug problems.

“This (Justice) Department is going after drug companies, doctors, and pharmacists and others that violate the law,” Sessions said. “Since January 2017, we have charged more than 150 doctors and another 150 other medical personnel for opioid-related crimes.  Sixteen of those doctors prescribed more than 20.3 million pills illegally.”

ATTORNEY GENERAL JEFF SESSIONS

The Drug Enforcement Administration, which Sessions oversees, is also seeking a rule change that could lead to further tightening of the nation’s supply of opioid medication -- in addition to the 45% in production cuts the DEA ordered over the last two years. The DEA wants to change the rules so it can arbitrarily punish drug makers who fail to prevent their opioid products from being diverted and abused.  

Sessions ‘Socially Irresponsible’

“I think they’re attacking it from the wrong end, to be candid with you,” says Tony Mack, the CEO and chairman of Virpax Pharmaceuticals. “Who is going to end up suffering is the real patients that have chronic pain and can’t get a hold of these opioids.”

Although Virpax is focused on developing non-opioid pain medication, Mack has a wealth of experience in opioid pharmaceuticals, having worked for Purdue Pharma, Endo and Novartis. In an unusually blunt interview for a drug company executive, Mack told PNN that Sessions’ focus on prescription opioids was “socially irresponsible.”

“I believe Attorney General Jeff Sessions needs to sit down and talk to some of these physicians who are pain specialists and understand that what he’s doing is going to put the chronic pain patient, the post-operative patient, and the patient that comes to the emergency room in serious jeopardy,” Mack said. “I think that Jeff Sessions is not educated well. I think he is picking on something that sounds good politically but doesn’t make sense socially. It’s socially irresponsible.”

Mack says pain patients would be caught in the middle if the DEA changes the opioid production rules and, for example, tells Purdue Pharma to stop selling OxyContin, its branded formulation of oxycodone.

“If you cut off that particular company, since they have more oxycodone out there than anyone, what will happen is patients will have to go to morphine or have to go to fentanyl,” Mack told PNN. “You’re not going to give patients the choices that they need to have in order to manage their pain. Not every single opioid works the same way for every single person. They all work differently."

Mack thinks the DEA’s earlier production cuts have contributed to nationwide shortages of IV opioid medications, which are used to treat hospital patients recovering from surgery and trauma.

“Absolutely, I do,” he said. “It’s just a domino effect to me. You’re going to send more patients home or you’re going to be postponing surgeries until they get opioids because they can’t do (surgeries) without it. It would be inhumane.”

Mack says efforts to limit opioid prescribing and production may have backfired, giving patients little choice but to turn to the black market for pain relief.

“I think they’re trying to throw the baby out with the bathwater here. They’re not thinking it through,” Mack said. “They’re probably going to increase the amount of (illegal) drugs out there. And patients aren’t going to try and get help, because they’re going to be on heroin. Not on a prescription medication. They’re going to be shooting up heroin.”

Lost in the debate over opioids and their role in the overdose crisis is this little known fact: A recent study by the Substance Abuse and Mental Health Services Administration (SAMHSA) found that psychotherapeutic drugs used to treat depression, anxiety and other mental disorders are now involved in more overdoses than any other class of medication. They include antidepressants, benzodiazepines, anti-psychotics, barbiturates and attention deficit hyperactive disorder (ADHD) drugs such as Adderall. Over 25,000 overdoses in 2016 involved psychotherapeutic drugs. That compares to 17,087 deaths linked to opioid pain medication.

CDC Report Ignores Suicides of Pain Patients

By Pat Anson, Editor

The suicide rate in the United States continues to climb, with nearly 45,000 people taking their own lives in 2016, according to a new Vital Signs report by the Centers for Disease Control and Prevention.

The suicide rate in the U.S. is so high it rivals the so-called “opioid epidemic.” The number of Americans who died by suicide (44,965) exceeds the overdose deaths linked to both illicit and prescription opioids (42,249).  The nationwide suicide rate has risen by over 30 percent since 1999.

“Unfortunately, our data shows that the problem is getting worse,” said CDC Deputy Director Anne Schuchat, MD. “These findings are disturbing. Suicide is a public health problem that can be prevented.”  

Contrary to popular belief, depression is not always a major factor in suicides. The report found that less than half of the Americans who died by suicide had a diagnosed mental health issue. Substance abuse, physical health problems, and financial, legal or relationship issues were often contributing factors. So was the availability of firearms, which were involved in nearly half of all suicides.

But while CDC researchers can go into great detail about the methods, causes, demographics, ethnicity and even the drugs used by suicide victims, they did not investigate anecdotal reports of a growing number of suicides among pain patients.

“Our report found that physical health problems were present in about a fifth of individuals as circumstances considered to lead up to suicide," Schuchat said in a conference call with reporters. "That doesn’t differentiate whether it was intractable pain versus other conditions that might have been factors.”

Asked directly if lack of access to opioid medication may be contributing to pain patient suicides, Schuchat said that federal agencies were “working on comprehensive pain management strategies,” but they were not investigating patient suicides, such as the recent tragic death of a Montana woman.

“We don’t have other studies right now. But I would say that the management of pain is a very important issue for the CDC and Health and Human Services,” she said.

PNN asked a CDC spokesperson if the agency was conducting any studies or surveys to determine whether the CDC's 2016 opioid guideline was contributing to patient suicides, and what impact it was having on the quality of pain care. The boilerplate response we received essentially said no, and that the CDC was only tracking prescriptions. 

"Through its quality improvement collaborative and its work with academic partners, CDC is evaluating the impact of clinical decisions on patient health outcomes by examining data on overall opioid prescribing rates, as well as measures such as dose and days’ supply, since research shows that taking opioids for longer periods of time or in higher doses increases a person’s risk of addiction and overdose," Courtney Leland said in an email.

As PNN has reported, the CDC’s guideline may be contributing to a rising number of suicides in the pain community.  In a survey of over 3,100 pain patients on the one-year anniversary of the guideline, over 40 percent said they had considered suicide because their pain was poorly treated.

Most patients said they had been taken off opioids or had their doses reduced to comply with the  CDC guideline, which has been widely adopted throughout the U.S. healthcare system. Many patients say they can’t even find a doctor willing to treat them.

‘Making Plans to End This Life’

“I am scared to death as pain for me is unbearable. If I cannot get a prescription for relief I will probably be one of those (suicide) statistics because as far as I'm concerned, my quality life would be gone and no longer worth living. I will be sure to leave a note telling the CDC to go to hell too,” one PNN reader said.

“If my life is reduced to screams of agony in my bed while my father has to watch, if that happens and I can’t take anymore suffering, I will leave a note (probably a very long one), and in it I will say that the people who are making these guidelines into law, should be charged with my homicide,” another patient wrote.

“My suicidal ideation has increased exponentially. I have now resorted to cutting and punishing myself in order to distract from the physical chronic pain I suffer with,” said another patient. “I am struggling terribly and can’t even get sleep. I have been making plans to end this life and if the pain continues without treatment, it will not be hard to do.”

“My wife has been talking about suicide as the only option to escape her chronic pain and migraine headaches. I am starting to think the same thoughts,” wrote a man who also suffers from chronic pain. “Many chronic pain patients left without a doctor or opiate painkillers will commit suicide to escape the pain and suffering. My wife and I included.”

British Columbia Revising Its Guideline

The Canadian province of British Columbia was one of the first to adopt the CDC guideline as a standard of practice for physicians. In April 2016, British Columbia declared a public health emergency because overdose deaths from illicit fentanyl, heroin and prescription drugs were soaring. In response, the College of Physicians and Surgeons of British Columbia released new professional standards and guidelines that were closely modeled after the CDC’s.

Two years later, the British Columbia guidelines are now being revised because too many patients were being denied care or abandoned by doctors fearful of prescribing opioids.

“Physicians cannot exclude or dismiss patients from their practice because they have used or are currently using opioids. It’s really a violation of the human rights code and it’s certainly discrimination and that’s not acceptable or ethical practice,” college registrar Heidi Oetter told The Globe and Mail.

Under the old guidelines, British Columbia doctors were strongly encouraged to keep opioid doses below 90 milligrams of morphine a day – the same recommendation as the CDC’s. Now they’re being told to use their own discretion and to work with patients in finding an effective dose.

“Hopefully it’s clear to physicians that the college is really expecting that they exercise good professional discretion, that they are really engaging patients in informed consent discussions and that patients are really aware of the potential risks that are associated with opioids, particularly if they’re taking them in conjunction with alcohol or sedatives,” Oetter said.

Not only were the old guidelines harmful to patients, they were ineffective in reducing overdoses. British Columbia still has the highest number of overdoses in Canada, with 1,448 deaths last year.

Overdoses also continue to soar in the United States – mostly due to illicit fentanyl and other street drugs. Will the CDC change its guideline -- as promised -- because it is harming patients and failing to reduce overdoses?

"CDC will revisit this guideline as new evidence becomes available," the agency said in 2016. "CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

Today’s report on suicides indicates the agency has no plans to do either.

New Campaign Against Bogus Online Pharmacies

By Pat Anson, Editor

The U.S. Food and Drug Administration has launched yet another campaign against illegal online pharmacies, sending warning letters to the operators of 53 websites that they must stop marketing oxycodone, tramadol and other opioid medications.

"This illegal online marketing of unapproved opioids is contributing to the nation’s opioid crisis,” said FDA Commissioner Scott Gottlieb, MD.  “Opioids bought online may be counterfeit and could contain other dangerous substances. Consumers who use these products take significant risk with their lives.”

Gottlieb said the FDA would take additional steps in coming months to stop the online sale of opioids and their shipment through the mail. The agency also plans to hold a summit June 27 with internet stakeholders, researchers and advocacy groups to find new ways to work collaboratively to address the problem.

Last September, the FDA sent similar warning letters to over 500 online pharmacies as part of an international operation called Pangea X. Interpol said it seized over $51 million in illicit and counterfeit medications as a result of the investigation. Over 400 people were arrested worldwide and 3,584 websites shut down.

The problem with these law enforcement efforts is that many of the bogus pharmacies are quickly back online under different names and website addresses.  

Some of websites being targeted in the latest FDA crackdown operate brazenly, offering opioids and other controlled substances without a prescription.

“One advantage of buying medication through our website is that it’s cheap and exciting. Sometimes, what happens is that the drug can only be bought with a prescription, and getting prescription is not that simple,” one operator claims. “(We provide) the solution to this. We don’t require any prescription or proof of recommendation. If you need any sort of medication, just go to our website, log in and place the order. After the payment is made, the order is finalized and shipped to your place.”

Another website claims “you won’t need a written prescription from a doctor as we have doctors within our team who will write your prescription free of cost.”

Online Pain Pharma then displays images of four smiling “doctors” with specialties in radiology, emergency care, radiology and rheumatology. The names appear fictitious and the pictures are stock photo images that can be purchased from a website that sells images of “Smiling Medical People With Stethoscopes.”

image from onlinepainpharma.com

Dr. Anna Mariya may be a radiologist for Online Pain Pharma, but on a pediatrician's website she’s an orthopedic specialist named Dr. Bagavativarasyar.  

The FDA warning letters were sent to nine online pharmacy operators, most of which have multiple websites. They were given 10 working days to respond.

• AnonShop
• Eassybuyonline
• Instabill ECS-Rx
• Medstore.biz
• One Stop Pharma
• RemedyMart
• RxCash.Biz
• TramadolHub
• XLPharmacy

"The public needs to know that no one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription," said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "Drug dealers and rogue website operators are using the internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder.”

According to one estimate, as many as 35,000 online pharmacies are in operation worldwide. About half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

FDA Monitors Social Media for Drug Abuse Trends

By Pat Anson, Editor

A recent letter in The New England Journal of Medicine sheds some light on how the Food and Drug Administration tracks changing patterns of drug use on Facebook, Twitter and other social media.

The FDA began monitoring social media – what it calls “proactive pharmacovigilance” – about a decade ago, primarily as an early warning system for adverse events involving medication.

More recently, the agency has used active surveillance of social media to study the abuse of opioid painkillers and gabapentinoids, a class of nerve medication that includes gabapentin (Neurontin) and pregabalin (Lyrica). Gabapentinoids are increasingly being prescribed as “safer” alternatives to opioids.

“To understand why usage patterns are shifting, the FDA used a social media ‘listening platform’ to set up a dashboard to track traditional social media sites (such as Twitter, Facebook, Instagram, blogs, and forums) that we monitor for conversations about opioids,” explained FDA commissioner Scott Gottlieb, MD, and co-authors Douglas Throckmorton, MD, and Janet Woodcock, MD, two senior FDA officials.

“When we find mention of additional substances on social media or elsewhere, we conduct more specific searches for relevant, publicly available conversations through our listening platform, as well as through Reddit, Google, and various online forums that don’t require registration or subscription. These may include forums associated with drug misuse or abuse, such as Bluelight.org and talk.drugabuse.com.”

What did the FDA learn about gabapentinoids on social media? Preliminary findings indicate the abuse of gabapentinoids isn’t widespread, but their use continues to increase, especially for gabapentin.

The FDA is also actively monitoring the social media sites of kratom vendors. As PNN reported last month, one vendor received a warning letter from the FDA for sharing on its Facebook page a CNN story about the herbal supplement as a possible treatment for pain and opioid addiction. The vendor only said the story was “positive news for kratom,” but the FDA said that amounted to the illegal marketing of an unapproved drug.

“The FDA thus faces challenges as we confront the opioid crisis and monitor changing patterns of use, abuse, and misuse of other products,” Gottlieb wrote. “The right approach to regulating these substances is best determined through a multifaceted system of pharmacovigilance, using various tools to mine traditional and new sources of epidemiologic data, assess products’ pharmacologic properties, and evaluate the social contexts in which substances are being used.”

To be clear, the FDA’s surveillance of social media isn’t very different from what private enterprise is already doing. NUVI, for example, provide social media monitoring to companies “to get real-time insights into what people are saying about your brand online.”  Companies also sell software that track keywords, hashtags and user profiles on social media. And PatientsLikeMe, the largest online patient network with over 600,000 members, sells some of its data to the FDA and healthcare industry.

At PNN, we do stories all the time about opioids, kratom, gabapentinoids and other drugs. Is Pain News Network under surveillance by the FDA? Are reader comments on our website and social media being monitored? We don’t know. But in an age of growing concern about Internet privacy and the sharing of personal data, we thought you should know that the answer could be yes.

CEO of U.S. Pain Foundation Resigns

By Pat Anson, Editor

The founder and CEO of the U.S. Pain Foundation – an advocacy group representing chronic pain patients -- has resigned under pressure.

Paul Gileno resigned Tuesday, May 29th at the request of the foundation’s board of directors, according to a statement released on Thursday by U.S. Pain. It is highly unusual for a non-profit’s board of directors to remove its CEO. No explanation was offered for Gileno’s sudden departure

Nicole Hemmenway, U.S. Pain’s chairperson, has been appointed as interim CEO. A search for Gileno’s replacement is underway.

“The organization is stable and excited to be moving forward on its mission – to empower, educate, connect and advocate for people living with chronic conditions that cause pain,” said  board member Ellen Lenox Smith. “The Board has complete faith in Nicole and the wonderful staff that makes up our organization.”

U.S. Pain has recently faced criticism over its relationship with Insys Therapeutics, an Arizona drug maker under investigation for its marketing of Subsys, an oral fentanyl spray blamed for hundreds of overdose deaths. Former Insys executives and sales representatives have been charged with racketeering and bribing doctors to prescribe Subsys off-label. A four day supply of Subsys can cost nearly $24,000.

In recent years, Insys has donated over $3.1 million to U.S. Pain, with most of the money going to a prescription discount program to help patients pay for Subsys and other medications prescribed for breakthrough cancer pain. Critics say the program was primarily designed to benefit Insys by allowing the company to bypass Medicare rules governing illegal kickbacks.

“Co-pay assistance programs (also called copay charities) were created to get around this restriction. Medicare allows copay charities to cover Medicare co-pays, so pharmaceutical companies funnel money through these groups to cover co-pay costs for Medicare patients while bilking Medicare, which bears the full cost of unnecessarily expensive drugs,” a group of critics said in a blog post by The Hastings Center.  

Last week Pfizer agreed to pay a $24 million fine to resolve federal charges that it used a similar co-pay assistance program to pay kickbacks to Medicare patients. “Pfizer used a third party to saddle Medicare with extra costs," said U.S. attorney Andrew Lelling.

In a statement released in February, Gileno defended U.S. Pain’s acceptance of funding from Insys for the co-pay assistance program.

"This funding, like any funding we receive, does not influence our values,” Gileno said. “The funding we receive is not used to promote one type of treatment over another.”

According to a report released by Missouri Sen. Claire McCaskill, U.S. Pain received $2.5 million from Insys in 2017 – an amount three times larger than what the non-profit received from all donors in 2015.

(Update: U.S. Pain has a statement on its website saying its copay assistance program with Insys ended “as of August 2018” and that “U.S. Pain will not accept funding from Insys going forward.”)

Gileno founded the Connecticut Pain Foundation in 2006 after a back injury forced him to abandon his catering business. In 2011, he launched U.S. Pain, which now claims to be the nation’s largest patient advocacy group. It's growth was fueled by marketing partnerships and donations from dozens of pharmaceutical companies and healthcare organizations.

In its 2016 promotional material, U.S. Pain claimed to have over 90,000 members and over 225,000 social media followers, including 59,000 followers on Twitter. However, that was reduced to less than 14,000 followers in early 2018 after Twitter purged from its system millions of fake accounts.

(Update: U.S. Pain has revised the way it counts actively “engaged members.” The organization now says its has over 15,000 members, 1,500 volunteers and a social media reach of more than 217,000 followers.)

In 2015, Gileno was paid a salary of nearly $404,000, according to U.S. Pain's tax return. Gileno says the 2015 compensation was for “back pay” from 2006 to 2012. The foundation has not publicly released its tax returns for 2016 or 2017, so we don’t know how much Gileno was paid for those years.

In a 2018 New Year’s message to U.S. Pain members, Gileno said he “would never sell out.”

“Not once has the creation of this foundation been about boosting my ego, finding public notoriety or obtaining fame. I am here to serve you. I will never jeopardize our mission or passion to gain five minutes of fame for myself," Gileno said.

"The work of U.S. Pain Foundation is 100% genuine. There are no strings attached or ulterior motives. All that I care about is further enhancing the lives of people suffering with pain, and we will continue to do so in a discreet and powerful manner."

PAUL GILENO

Gileno has been criticized by some in the pain community for a passive approach to patient advocacy that avoided public controversy and protest. Some say he also has an overbearing personality that rubbed people the wrong way.

“There are so many reasons I could cite as to why it’s good to have Paul out, but I am biased because he was one of my biggest bullies and a thief to others in the chronic pain community,” a longtime patient advocate who asked to remain anonymous told PNN. “I am hoping the leadership at U.S. Pain Foundation will do better than they have in the past.”

Interim CEO Nicole Hemmenway has been a key member of U.S. Pain since its inception. She has lived with Complex Regional Pain Syndrome (CRPS) most of her life.

“We’re very focused on the future. We have a lot of wonderful programs and events coming up – a training program for chronic pain support group leaders in June; our Pain Awareness Month campaign and related activities this September; and our first retreat for pediatric patients this November,” Hemmenway said in a statement.

Is CDC Opioid Guideline Harming Cancer Patients?

By Pat Anson, Editor

It was only intended for primary care physicians who treat chronic non-cancer pain, but the CDC’s opioid prescribing guideline has had a sweeping effect on the practice and quality of pain management in the United States.

The guideline is also causing confusion among oncology specialists who treat cancer and adding to the “already appalling burden of unrelieved cancer pain,” according to an op/ed being published in JAMA Oncology.

Two experts in oncology and palliative care at the University of Pennsylvania say some of the CDC’s recommendations are based on weak evidence and conflict with national cancer pain guidelines.

"This lack of evidence, coupled with conflicting and competing contemporary guidelines from diverse authoritative agencies and organizations carry the potential to confuse, if not seriously jeopardize, pain management for patients with cancer who are living with moderate to severe pain, adding to an already appalling burden of unrelieved cancer pain," wrote Neha Vapiwala, MD, and Salimah Meghani, PhD.

Meghani is a Professor of Nursing and Chair of Palliative Care at the University of Pennsylvania School of Nursing, while Vapiwala is a Professor of Radiation Oncology and Vice Chair for Education in the Perelman School of Medicine at the University of Pennsylvania.

Although the CDC guideline is intended for chronic pain patients outside of active cancer treatment, it includes patients “who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only.”

Meghani and Vapiwala say the CDC’s inclusion of “cancer survivors” is a mistake because it is not uncommon for cancer pain to persist long after the cancer is treated.  

“Unfortunately, this arbitrary distinction is not consistent with the evidence of pain trajectory in cancer survivors,” the wrote. “More important, similar levels of pain were reported in survivors who were still receiving cancer treatment and those who had completed active cancer treatment.”

The CDC guideline also conflicts with the guideline of the National Comprehensive Cancer Network (NCCN), which is widely used by oncology physicians. The NCCN recommends that doctors use both short and long-acting opioids when treating flares from cancer pain, while the CDC recommends against long-acting opioids because of the potential risk of addiction.

The CDC also recommends that non-pharmacologic therapy such as meditation and non-opioid drugs such as gabapentin (Neurontin) be used for chronic pain. But Meghani and Vapiwala say there is little evidence those therapies work in managing moderate to severe pain.  They're urging the CDC, NCCN, American Medical Association and other organizations to develop more uniform guidelines based on solid evidence.

"Many of the current recommendations around opioid prescribing practices stem from expert consensus rather than empirical research, which is urgently needed to generate and develop informed guidelines for patients with chronic cancer-related pain," they wrote. "Clinicians who care for patients with cancer are frustrated by an increasingly overwhelming set of institutional, regulatory, and policy requirements around opioid prescribing that can interfere with being good stewards and advocates for their patients with pain.”

Cancer Patients Denied Opioids

Some cancer patients say the CDC guideline has interfered with their treatment.

“I had a painful radical surgery for cancer and was only provided 3 days of low-dose opioids per CDC guidelines and suffered terribly for 2-3 months. Still have persistent pain 5 months later due to poor acute pain control,” one PNN reader told us.

“My brother in law was just diagnosed with stage 4 pancreatic cancer with metastasis to the liver and his first oncologist refused to treat his pain adequately due to the CDC guidelines, telling him I'm not risking my license for you,” another reader said.

“I have a family friend who is a cancer patient in her mid-sixties. Her doctor pulled her off of her morphine without warning, and she has been left to suffer,” wrote another.

“I'm stuck with a bad physician in order to get pain management. No other doctor in this county will do pain management,” said a patient who has to drive 45 miles to get treatment. “My doctor misdiagnosed my stomach illness and missed my cancer all together.”

Other patients say their pain is just as bad or worse than cancer pain – and don’t understand why they are treated differently under the CDC guideline.

“These are guidelines, not meant for all patients. And to exclude ONLY cancer patients is outrageous,” wrote one patient who was born with a rare and painful digestive disease. “Why should I have to be penalized because I have a rare disease and not cancer? These rules and regulations that are coming out make me wish I had a cancer diagnosis.”