FDA Ends Probe into Kratom Salmonella Link

By Pat Anson, Editor

The Food and Drug Administration has ended its investigation of a small salmonella outbreak linked to kratom – but not without taking some parting shots at the herbal supplement used by millions of Americans to treat chronic pain, addiction, depression and other conditions.

“It appears the salmonella problem with kratom uncovered earlier this year has probably been occurring for some time and is ongoing. We have closed our outbreak investigation, concluding that anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella,” said FDA commissioner Scott Gottlieb, MD, and Stephen Ostroff, MD, FDA Deputy Commissioner for Foods and Veterinary Medicine, in a lengthy joint statement.

The FDA ended its investigation five weeks after the Centers for Disease Control and Prevention wrapped up its own probe of the salmonella outbreak that sickened 199 people in 41 states. The CDC investigation began in February of this year, but salmonella illnesses linked to kratom were traced back as far as January 2017.

No single source of the outbreak was ever identified, but kratom was considered the “likely source.” A little over half of the 81 kratom samples that were analyzed tested positive for strains of salmonella bacteria.

“This means that users of these products had essentially a one in two chance of being exposed to this pathogen,” Gottlieb and Ostroff said. “The more than 50 percent contamination rate is stunningly high. It represents a level rarely seen in outbreak investigations of this nature. It shows that a high proportion of kratom being shipped into the United States may be contaminated with salmonella.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural pain reliever and stimulant, particularly in rural areas of Indonesia and Thailand.  

“In these locations, the plant is being grown, harvested and processed in problematic conditions that readily create the circumstance for widespread contamination with foodborne pathogens. Although some of the kratom is further processed once in the United States into capsules, powders or herbal remedies, based on our findings, these procedures do not appear to be eliminating microbial contamination,” wrote Gottlieb and Ostroff.

In recent years, millions of Americans have discovered kratom and started buying it online or in convenience stores and “head shops.” But not until this year did federal health officials show any concern that kratom products were contaminated with salmonella bacteria. Their primary focus was that kratom was being marketed as an unapproved medical treatment, particularly for pain and addiction.

The FDA has even started calling kratom an addictive “opioid,” when in reality its active ingredients are mitragynine and 7-hydroxymitragynine, two alkaloids that are believed to act on opioid receptors in the brain. Earlier this year, the FDA released a computer analysis that found kratom contains over two dozen opioid-like substances – a report that critics say was biased and amounted to “junk science.”

Over a dozen kratom products were recalled during the FDA and CDC salmonella investigations. Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Severe cases can result in death.

There have been several other salmonella outbreaks this year, including infections linked to melons, raw sprouts, dried and shredded coconut, live poultry, chicken salad, pet guinea pigs, and Kellogg’s Honey Smacks cereal.

Opioid Medication Made My Chronic Pain Worse

By Robert Gripp, Guest Columnist

After 18 years of largely untreatable chronic pain, I found myself with an intrathecal pain pump delivering huge quantities of fentanyl to my spine every day. And I was still in debilitating pain.

I was on my second pain pump (they have to be replaced about every seven years) when the pump began to act up and I started into withdrawal. I immediately saw my new doctor, who had taken over my care when my original doctor retired at age 75.

He had the pump manufacturer’s representative there to help figure out what was going on. It turned out the pump was unreliable, and the doctor recommended it be powered off. I was sent home with minimal meds to detox.

Detox was the absolute most horrible experience I have ever encountered, but at the end I was virtually pain free. The reason was that I had developed opioid-induced hyperalgesia (OIH), which increased my sensitivity to pain.

ROBERT GRIPP

OIH is a well-documented syndrome, but my doctors had missed the hallmark signs of it, which are changes in the location and characteristics of your pain, as well as little or no relief from pain when the dosage is increased.

I am now 63 years old and have a new life. I have some pain, but nothing that is not well controlled with little or no opioids.

I do not believe that all patients who take high doses of opioids experience hyperalgesia, nor does the literature support any such conclusion. My purpose is to caution anyone on high doses for an extended period. If it is not helping you or your pain is worse after increasing the dosage, you should be aware of this condition and its potential.

Overzealous lawmakers and over-reaching insurance companies who want to limit opioids due to the addiction crisis don’t have a clue. Limiting opioids is making it harder for pain patients who really need them. But my experience is also something that needs to be better understood and the condition of hyperalgesia needs to be more publicized.

Our tendency is to believe more pain medicine is better when our pain worsens. I have to wonder how many people are out there in tremendous pain being caused by the very medicine given them to abate it. I am afraid it is way too many.

I hope my story helps someone get a new life, without having to stumble onto it as I did.

Robert Gripp lives in Texas.

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.

Migraine Costly to Workers and Employers

By Steve Weakley

Most employees who suffer from chronic migraine headaches miss nearly a full week of work (4.6 days) due to migraines each month, according to a large new online survey.

Amgen and Novartis surveyed over 11,000 migraine sufferers in 31 countries to demonstrate how painful and costly the condition can be for both workers and employers.  The My Migraine Voice survey included people who had four or more migraine days a month.

Eighty percent of the survey takers in the U.S. said their employers knew about their migraines, but only 21 percent said their bosses offered support and understanding. Nearly two-thirds (63%) said migraines impaired their work performance and many felt judged by co-workers as a result.

"From being afraid to speak up about their disease at work in fear of losing their jobs, to feeling judged by colleagues, the stigma around migraine in the workplace is an ongoing issue that the migraine community faces daily," said Mary Franklin, executive director of the National Headache Foundation, in a press release.

"The findings from the My Migraine Voice survey shed light on the true impact of migraine at work, and showcase the urgent need for employers and employees to change the dialogue around migraine."

According to one estimate, U.S. employers lose about $11 billion a year in missed work and lost productivity because of migraines.

Amgen and Novartis presented the survey findings at the 60th annual meeting of the American Headache Society in San Francisco, to help stir up interest in their new injectable migraine drug, Aimovig (erenumab). The FDA recently approved the monthly self-injected drug for the prevention of migraine in adults.

Aimovig uses human antibodies to target brain receptors that are thought to trigger migraines. Three clinical trials demonstrated that the drug reduced the number of migraine days for sufferers by an average of 2.5 days per month.

One obstacle in getting people to try Aimovig is its price. Amgen say the drug will cost about $6,900 a year, or $575 for each monthly dose. Amgen holds the sales rights for Aimovig in the United States, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.

Amgen is offering a migraine management program to several large U.S. employers. The program consists of an educational program as well as a research study to document the impact of migraine on worker absenteeism, presenteeism, healthcare utilization and costs. The wellness portion of the program includes webinars, email and website tips, and a  mobile app to track migraine symptoms.

CDC Head Wants Opioid Guidelines for Acute Pain

By Pat Anson, Editor

When Dr. Robert Redfield was appointed as director of the Centers for Disease Control and Prevention in March, he told CDC staff the opioid epidemic was “the public health crisis of our time” and pledged to “bring this epidemic to its knees.”

After three months in the job, Redfield has finally given his first media interview and provided some vague details about how he will tackle the opioid crisis. He told The Wall Street Journal that the CDC would develop opioid prescribing guidelines for short-term acute pain and use a new enhanced data system to track overdoses in hospital emergency rooms.

“We’re going to continue to expand our efforts,” Redfield said. “We’re going to be able to track this epidemic in real time, which I think is really important to be able to respond.”

The CDC has been roundly criticized in the past for how it tracked and counted opioid overdoses – erroneously mixing illicit fentanyl deaths with those linked to prescription opioids – so any improvement in that area is welcome.

DR. ROBERT REDFIELD.

But for the agency to even consider prescribing guidelines for acute pain is puzzling – considering how disastrous its guidelines have been for chronic pain. Since their botched release during a sketchy webinar in 2015, the CDC’s “voluntary” guidelines for primary care physicians have been widely adopted as mandatory by insurers, regulators and providers – who have used them to deny treatment, abandon patients, and forcibly taper many off opioid prescriptions. The DEA even targets physicians who exceed the CDC's recommended dosage for opioids. 

“I was forced tapered. How could the CDC take over my medical treatment? How is this legal? The CDC had never assessed me yet changed my pain medicine,” PNN reader Patti asks.  “I've gone from being an active woman to spending my days in bed or on the couch. I live in non-stop pain 24/7.”

Patti is not alone. In a PNN survey of over 3,100 patients last year, over 90% said the CDC guidelines have been harmful to patients and nearly half said it was harder for them to find a doctor willing to treat their pain. Ten percent don't have a doctor at all.

There are also troubling reports of patients committing suicide because their pain is so poorly treated.

"My son committed suicide 4 months after his docs took him off all pain meds," said Rick. "I knew right then the reason for his suicide. But, it goes unrecognized by doctors and other officials, and his suicide autopsy mentioned nothing about pain meds. This will continue, suicides vastly increased until post medicinal suicides (are) recognized and accounted for."

"My 70 year old mother committed suicide last month after being cut off at pain management. Although she could barely walk and was in constant pain, she was the most positive person. Something needs to be done," said Janie Jacobs.

“Wishing for it to be over is a pervasive daily thought. I have to work diligently to chase those thoughts away,” pain patient Leanne Gooch wrote in a recent guest column for PNN. “My doctors can’t or won’t treat me because my chronic pain contributed to all the addicts all over the world. I’ll admit that’s a ridiculous statement when they admit they’ve gone too far in denying me proper medical care.”   

The quality of pain care in the U.S. has gotten so bad that Human Rights Watch launched an investigation into the treatment of pain patients as a possible human rights violation.

“What kind of quality of life do I even have when I can barely move?” asks Amy, who suffers from myofascial pain and is confined to a wheelchair.  “I really want to lead a functional life and to have a family. It's not a lot to ask. I'll never have it this way, though. Please give me back some tramadol. Please allow me hydrocodone if I really need it. Please help me. Please help all of us.”

The CDC guidelines have also failed to achieve a key objective. While opioid prescribing has declined (a trend that began years before the guidelines were released), opioid overdoses have spiked higher, driven by a scourge of illegal opioids sold on the black market. Americans are now more likely to die from an overdose of illicit fentanyl than they are from pain medication.

Several states and insurers have already adopted regulations limiting the initial use of opioids for acute pain to a few days supply. The CDC has weighed in on the issue as well.

"When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed," the agency says in its chronic pain guidelines. 

According to a spokesperson, the CDC was working with the Agency for Healthcare Research and Quality (AHRQ) to develop a report reviewing the effectiveness of opioid and non-opioid therapies for acute pain.

"If an update to the CDC Guideline is warranted based on the scientific findings of these AHRQ efforts, CDC will undertake the scientific process to update the guideline, possibly including expanded guidance treating acute pain," Courtney Leland told PNN in an email.

Why does Dr. Redfield want to develop guidelines for acute pain? In his interview with The Wall Street Journal,  Redfield said his interest stems, in part, from a close family member’s struggle with opioid addiction.

“I think part of my understanding of the epidemic has come from seeing it not just as a public-health person and not just as a doctor,” he said. “It is something that has impacted me also at a personal level.”

The epidemic is also impacting chronic pain patients, in ways the CDC has yet to admit or acknowledge.

Doctors Won’t Treat My Chronic Pain

By Leanne Gooch, Guest Columnist

I have never been addicted to anything.

I feel the need to preface any conversation about my chronic pain with that statement. I have degeneration in my neck, arthritis, spinal stenosis, failed back surgery syndrome, and some other names that have been thrown into my medical charts. 

A layperson without chronic pain would wonder why I feel the need to document every boring detail of my health history. It’s because I’ve had to explain every minute detail to each and every provider I’ve seen. For 20 years!  

Initially, when my pain started, I had a good primary care doctor who tried hard to find and treat the cause. He prescribed pain medications and sent me to many specialists. But after injections, physical therapy, rehabilitation, etc., he became the first in a long line of doctors who would not treat me as a pain patient. 

I wasn’t considered “chronic” until the 10th year. I learned during that time that women are viewed by the medical profession as weak for reporting their pain. I have seen the faces of both men (doctors) and women (nurses) who judged my pain story as being overly dramatic and embellished.  

I was eventually sent to a hotshot, top-of-his-game neurosurgeon. He said I had degeneration in my spine that they would normally see in elderly patients, 60 or 70 years of age. I was told a surgery would fix me all up. They would cut, put some donor bone in, some screws to hold it all together, and that constant aching pain would be gone!

I signed on the dotted line. I was only 25 years old. Of course, now we know those surgeries are a very bad idea, especially for someone so young, because even if they’re effective in the short term, all that hardware eventually leads to further degeneration with age. 

I had a spinal fusion, was patted on the head and sent my way. In follow-up exams with the surgeon, I was told everything was perfect and that my pain would subside when I healed. “Go live your life,” he said.

LEANNE GOOCH

Yeah, not so much. I spent the next four years in even more pain and was dismissed by no less than six doctors, who claimed that because my x-rays showed everything was fine, I must be fine. I didn’t need further treatment. I didn’t need pain medication. There’s no way I could be in the pain I claimed to be in. 

Eventually, I got in with another hotshot surgeon, but this time it was at a hotshot hospital! They finally unearthed the fact that my fusion never did fuse. I had another surgery, but there were complications. They said my body rejected the donor bone. The bone would have to come from me, from my hip. They would need to cut the front and back of my neck, and my hip. They’d also put in more screws, metal plates and a metal bracket. 

The second surgery was not successful in ridding me of any pain. 

I was back on the merry-go-round of trying to find another doctor. In the interim, I’d gain and lose jobs due to whatever had taken up residence in my once amazingly functional body. I’d gain and lose medical insurance as well. Needless to say, I also went into deep and terrifying medical debt, while also being denied pain treatment. I was ineligible for individual policies because I had a pre-existing condition. 

I was forced into taking antidepressants when I didn’t need them. I wasn’t depressed, I was in pain. I was also forced to undergo counseling twice; both times I was dismissed after one visit because it wasn’t a mental issue I was dealing with. I was too embarrassed to properly express my pain levels. Forced to downplay how desperate I was for pain relief. 

I was even turned away by receptionists, who flatly and rudely said, “We don’t see or treat pain patients.”

That’s a short synopsis of why I am where I am 20 years later, essentially bedridden. The pain doesn’t allow for restful sleep. I can feel my health disappearing. I now have weight issues from hypothyroidism, no appetite most of the time, insomnia that doctors won’t treat, and very high blood pressure. 

After 18 years, I finally got to a pain clinic, as they call them now. The doctor has two physician assistants, one who believes everyone is a drug addict and one who wants to do a good job, but whose hands are tied by government guidelines and overreach. 

I am under-treated by a long shot, yet I am harassed by the pharmacist every single month. I use one pharmacy and one doctor, but still run into denial or delay getting a prescription filled. I had to explain and essentially beg the pharmacist to get a small script filled after my most recent invasive surgery for a spinal cord stimulator. 

Four months later, I’m still in tremendous pain and have a nearly constant tremor in my right arm. The stimulator seems to hit on a nerve and my muscles seize up, the pain rising to levels that I didn’t know a human could withstand. It’s awful. It’s painful. And I am under-medicated because of criminals I never had a thing to do with. 

I have been told that my pain will never get better and can never be cured. It will only get worse as the degeneration continues. Wishing for it to be over is a pervasive daily thought. I have to work diligently to chase those thoughts away, so as not to fall prey to giving up.

My doctors can’t or won’t treat me because my chronic pain contributed to all the addicts all over the world. I’ll admit that’s a ridiculous statement when they admit they’ve gone too far in denying me proper medical care. 

I am 43 years old.

Leanne Gooch lives in Missouri.

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.

Over 600 Arrested in Healthcare Fraud Sweep

By Pat Anson, Editor

Over 600 doctors, nurses, pharmacists and other medical providers have been arrested in what the U.S. Justice Department is calling its largest healthcare fraud investigation.

Most of the charges involve false claims for opioid prescriptions or addiction treatment that resulted in $2 billion in fraudulent billings to Medicare, Medicaid and other health insurers. Many of the arrests occurred weeks or months ago, and were apparently lumped together by federal agencies to make the crackdown on healthcare fraud appear to be the "largest ever." 

“This is the most fraud, the most defendants, and the most doctors ever charged in a single operation -- and we have evidence that our ongoing work has stopped or prevented billions of dollars’ worth of fraud,” said Attorney General Jeff Sessions.

Federal officials also announced that they have excluded 2,700 individuals from participating in Medicare, Medicaid and other federal health programs, including 587 providers excluded for conduct related to opioid diversion and abuse. 

“Health care fraud is a betrayal of vulnerable patients, and often it is theft from the taxpayer,” said Sessions.  “In many cases, doctors, nurses, and pharmacists take advantage of people suffering from drug addiction in order to line their pockets. These are despicable crimes.”

A $106 million scheme uncovered in Florida alleged there was widespread fraudulent urine drug testing at a substance abuse treatment center. The owner, medical director and two employees at the sober living facility allegedly recruited patients and paid kickbacks to them for participating in bogus drug tests.

In California, an attorney at a compounding pharmacy allegedly paid kickbacks and offered incentives such as prostitutes and expensive meals to two podiatrists in exchange for bogus prescriptions written on pre-printed prescription pads. Once the fraudulent prescriptions were filled, about $250 million in false claims were submitted to federal, state and private insurers.

In Texas, a pharmacy chain owner, managing partner and lead pharmacist were accused of using fraudulent prescriptions to fill bulk orders for over one million hydrocodone and oxycodone pills, which the pharmacy then sold to drug couriers for millions of dollars. 

“Healthcare fraud touches every corner of the United States and not only costs taxpayers money, but also can have deadly consequences,” said FBI Deputy Director David Bowdich.  “Through investigations across the country, we have seen medical professionals putting greed above their patients’ well-being and trusted doctors fanning the flames of the opioid crisis.”

Since becoming Attorney General, Sessions has shown a particular interest in opioid prescriptions -- once urging pain patients to “tough it out” and take aspirin instead.

Last August, Sessions ordered the formation of a new data analysis team, the Opioid Fraud and Abuse Detection Unit, to focus solely on opioid-related health care fraud.  Five months later, Sessions launched a Justice Department task force targeting manufacturers and distributors of opioid medication, as well as physicians and pharmacies engaged in the “unlawful” prescribing of opioids.

As PNN has reported, the data mining of opioid prescriptions -- without examining the full context of who the medications were written for or why – can be problematic. Last year the DEA raided the offices of Dr. Forest Tennant, a prominent California pain physician, because he had “very suspicious prescribing patterns.” Tennant only treated intractable pain patients, many from out-of-state, and often prescribed high doses of opioids to patients because of their chronically poor health -- important facts that were omitted or ignored by DEA investigators. Tennant has not been charged with a crime, but announced plans to retire after the DEA raid.

Sessions has also proposed a new rule that would allow the DEA to punish drug makers if their painkillers are diverted or abused. If approved, the agency could reduce the amount of opioids a company would be allowed to produce, even if the drug maker had no direct role in the diversion.

Most overdoses are not linked to opioid pain medication, but are more likely associated with illicit fentanyl, heroin, anti-anxiety drugs or antidepressants.

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.  

Wear, Tear & Care: The Curable App

By Jennifer Kilgore, PNN Columnist

Nobody wants to be told that pain is in their head. If you’ve been in an accident like I have or suffer from a debilitating condition, that translates to: “This pain is your fault. You’re just lazy. If you tried harder, you wouldn’t be in pain.”

Pain is in your head. Pain is a signal that says your body is in danger, and for many people that switch never turns off. It becomes chronic, endless, crippling and traumatizing. This leads to a sort of fossilization in which we are scared to move, because movement hurts. Our lives become smaller, but the pain becomes larger until it consumes the entire world.

When my pain therapist suggested I try EMDR therapy (eye movement desensitization and reprocessing) for post-traumatic stress disorder, I resisted for two years. Why should I have to make a concerted effort to get rid of my pain and work through memories of crumpled metal and squealing tires? Why was it my responsibility to fix things when somebody else’s negligence was the cause of my injuries?

As always, it’s more complicated than that. My pain signals have coalesced over the past 15 years into a body-wide tangle of energy that never stops hurting. It spreads from my back up to my neck, down into my arms and legs, wrapping around my ribs. Pills are thrown into the void. Devices are worn. The pain remains.

I can’t even remember how I stumbled across the Curable app. I think it came up on a Facebook ad, though I do get many Google Alerts for this type of product. Either way, I now have it downloaded and pay for the annual subscription ($6.39 per month).

CLARA

The Curable app is like having a virtual therapist -- her name is Clara -- on my phone designed specifically for chronic pain. I can work through these memories in the comfort of my own home, on my own time.

As described in their FAQ: “Curable is an online pain psychology program. Modern research tells us that recurring pain is caused by multiple complex and interconnected factors. Treatments like drugs or chiropractic try to target some of the chemical or structural issues, but these issues are only part of the equation when it comes to recurring pain.”

Pain researchers have discovered that the way we act and think play a significant role in pain reduction. I’m not saying that people don’t have valid injuries -- I broke my back in four places and have two fusions in my neck -- but I know, deep down, that my level of pain does not make sense. There were structural abnormalities. Most of them were fixed.

What’s left?

The rest remains in my head, and I am quite curious to see what is actually pain and what part is catastrophizing, fear, anger and stress. Curable says that this cycle of pain can be “deprogrammed,” and the app trains patients to tease apart what is real pain and what is not.

The program is easy enough to use. It can be done entirely on a computer, tablet or phone, and it’s compatible with almost every device.

Clara, the virtual pain coach, interacts with you by a stream of text messages, and it honestly feels like I’m talking to a friend who just gets me. She sends information and leads you from one activity to another, offering resources, exercises and funny gifs to help you “reverse the cycle of pain going on in your brain.”

Each session is between five and 20 minutes, and lectures run about the same length. Some of them are difficult -- for instance, I’m resisting the “Identifying Your Stressors” exercise in which I have to free-write, simply because I don’t want to face that part of my brain. It’s hard. I don’t particularly like waging battle against a part of myself, no matter how unwelcome that part is.

Clara even noted that many users find the writing exercises difficult and avoid them in favor of the other activities, because who wants to commit to such a level of self-reflection?

The makers of the app know this, and they get how hard it is because all three of the founders suffered from chronic pain. That level of understanding makes all the difference.

Curable is designed for three weekly sessions, though any pace can be set. A survey of users showed that some reported a reduction to zero pain within three weeks of trying the app. Everyone’s pain experience is unique, however, and they acknowledge that “there is no correlation between the total number of exercises you complete… and when you will begin to experience relief.”

As they also note, “Racing through the program ‘to feel better faster’ will not work.” I’ve found that racing through is pretty much impossible, because facing all of these thoughts and memories is exhausting.

I’m very excited about this app. I think it will be a great complement to my EMDR therapy and can keep me on track when my therapist can’t. Clara even speaks to me in a way that only other pain patients do. She understands our language, and the relief from that is staggering.

You can try the Curable app for free here.

Jennifer Kain Kilgore is an attorney editor for both Enjuris.com and the Association of International Law Firm Networks. She has chronic back and neck pain after two car accidents.

You can read more about Jennifer on her blog, Wear, Tear, & Care.  

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.

FDA Approves First Marijuana-Based Prescription Drug

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved the use of Epidiolex, the first drug derived directly from marijuana, to treat seizures caused by two rare and severe forms of childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

Epidiolex is the first FDA-approved medication that contains cannabidiol (CBD), one of the active ingredients in marijuana. It does not contain tetrahydrocannabinol (THC), the chemical compound in marijuana that makes people high.

“This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition,” FDA commissioner Scott Gottlieb, MD, said in a statement.

FDA approval of Epidiolex is a major milestone for GW Pharmaceuticals, a British company focused on developing CBD-based medications. The company said Epidiolex would be available in the fall, but did not disclose the price. Some analysts have predicted it could cost as much as $25,000 a year.

Many oils and tinctures containing CBD are already sold online and in states were medical marijuana is legal, but the FDA has not approved any of them. The agency has only approved a handful of synthetic cannabinoids such as Marinol (dronabinol) to treat loss of appetite and nausea.

“We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products,” Gottlieb said.

“But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Some children in clinical trials experienced side effects from Epidiolex such as liver toxicity, anemia and drowsiness, but an FDA staff report said the risks were “mild to moderate” and could be managed with warning labels. The staff report also found there was low risk of the strawberry flavored Epidiolex being abused.

“Today’s approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies,” Justin Gover, GW Pharmaceutical’s CEO, said in a statement.

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

While Epidiolex is only approved for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, doctors will presumably be able to prescribe it “off label” for other conditions such as chronic pain.  

GW Pharmaceuticals also makes Sativex, an oral spray that contains both CBD and THC. Sativex has been approved in Europe, Canada, Australia, New Zealand and several other countries for the treatment of muscle spasticity caused by multiple sclerosis. In Israel, Sativex is also approved for the treatment of pain and chronic non-cancer pain.  

One Is the Loneliest Number

By Ann Marie Gaudon, PNN Columnist

Part of what makes pain "painful" is the feeling of being misunderstood and the feeling of aloneness.

"Nothing is quite so isolating, as the knowledge that when one hurts, nobody else feels the pain,” Robert Murphy wrote in his memoir, “The Body Silent: The Different World of the Disabled.”

When you combine a sufferer who sees only pain with someone who can't see it at all, a barrier often springs between the two.  Pain causes this barrier because it inverts our typical perspective. No longer able to reach out to others for work or leisure, pain patients turn inward and life becomes about self-protection. Something is wrong inside of us, so we must tend to it and ensure it doesn't get any worse. This is an evolutionary response for survival; it’s instinctive and quite normal under these circumstances.

Once patients are constrained in their daily activities, a large part of their social world and the emotional health that depends on it can quickly deteriorate. Relationships are arguably the largest part of what makes life worth living.  In contemporary Western society, our self-confidence and identity arise from social interactions.

But as chronic pain sufferers’ lives become more restricted and limited, they frequently experience an erosion of their former self-image without the simultaneous development of a new one.

For example, I have heard: “I was a nurse, a mother, a wife, a friend, a daughter, and a sister, but now all of that is gone and I am alone in a cage with my pain.”

When isolated and in pain, our mind can become our worst enemy. The collapse of one’s social world can result in feelings of anxiety, emptiness, loneliness, anger, sadness, grief, guilt and low self-worth.

All of this psychological stress (aka “dirty pain”) is a response to your physical pain (aka “clean pain”).

Stress is a complex cascade of physical and biochemical responses to strong emotional stimuli. Emotions are electrical, chemical and hormonal discharges of the human nervous system. When not processed in a healthy manner, they can generate or increase pain and illness.

People can and do help themselves. Some join groups. If possible, join a walking group for exercise. If you don’t like walking, join another. The point is not so much what the group is doing, but rather that you are in a social situation.

Online forums are another way that people connect, especially if one is mainly housebound. Online communication can help you feel not so alone with your pain.

Maybe it’s possible for you to open up your home to low-maintenance company. Host a popcorn and movie night, or it could be cards or board games. You do the choosing, including when it begins and ends. Start with a single and simple event to prevent over-exertion and see where it leads.

Remember, what’s important is that you are building and maintaining relationships. To the extent that it’s possible, stick with those who support you. This could mean family, friends or even a support group for your condition, which can be a platform to form meaningful relationships with people who understand you. By listening to each other, you both know that you are heard and that you are not alone.

Some folks make their pain more communicable and thus sharable through pictures, artwork or expressive writing. Oftentimes this helps to bring barriers down to help others understand how you are feeling. There are no rules, you choose your form of expression.

Finally, realize that it is not your fault that you live in a pained body. Adding self-blame to your list of challenges will only make things worse for yourself. Learn to ask for help when you need it. Asking for help is never a weakness but is an act of self-compassion. I work extensively with clients on self-compassion, most of whom are quite naïve about it. If beating yourself up were the way to better health, wouldn’t you be the healthiest person on the planet by now?

I also work with people to get realistic about their life and expectations. What can stay? What can go gracefully to make room for new ways of being?

People aren’t broken, they’re just stuck. It’s not always easy, but with new learning, adaptations and support, people also become unstuck.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for 33 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website.

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

Women Most at Risk for ‘iPad Neck’

By Pat Anson, Editor

If you have neck and shoulder pain and regularly use an iPad or tablet device, there’s a good chance the two are connected. Especially if you’re a young woman.

A recent study of over 400 university students, alumni and staff found that 60 percent have persistent pain in the neck and upper shoulders – often caused by slouching or bending to watch their iPads or tablet computers. Over two-thirds (68%) said they experienced symptoms while using their tablets.

"Such high prevalence of neck and shoulder symptoms, especially among the younger populations, presents a substantial burden to society," said lead author Szu-Ping Lee, PhD, a physical therapy professor at the University of Nevada Las Vegas. His study was published last week in the Journal of Physical Therapy Science.

The top risk factor for “iPad neck” was surprising. Women were twice as likely as men to experience neck and shoulder pain during tablet use.

“Our study revealed that females and individuals with current musculoskeletal symptoms were more likely to be at risk for neck and shoulder symptoms,” Lee wrote.

“Certain postures during use were also identified as important risk factors, specifically sitting without back support and with the tablet in lap were significantly associated with symptoms during use.”

UNLV IMAGE

The most frequently reported symptoms were stiffness, soreness or aching pain in the neck, upper back, shoulder, arms, hands or head. Most of those surveyed (55%) reported moderate discomfort, but 10 percent said their symptoms were severe and 15 percent said it affected their sleep. Less than half (46%) said they stopped using the devices when they felt discomfort.

Lee says the findings concern him, especially given the growing popularity of tablets, e-book readers, and other devices for personal, school and business purposes. At PNN, we know that about 10 percent of our readers use iPads or tablets.

Almost half of the tablet users surveyed use their devices for three or more hours each day. Flexing the neck forward for long periods of time puts pressure on your spine, causing neck and shoulder pain. Sedentary behavior and bad posture while reading are also contributing factors.

Researchers say many students sit cross-legged on the floor when studying on their tablets. Interestingly, women were far more likely (77%) to use their tablets while sitting on the floor than men (23%).

Lee offered these tips to avoid iPad neck:

• Sit in a chair with back support.
• Use a posture reminder device -- small, wearable devices that beep to alert you when you're slouching.
• Place your iPad on a stand (rather than a flat surface) and attach a keyboard to achieve a more upright posture.
• Exercise to strengthen your neck and shoulder muscles.

"Using these electronic devices is becoming a part of our modern lives," Lee said. "In order to reduce the risk of developing long-term neck and shoulder problems, we need to think about how technology like tablet computer affects human ergonomics and posture."

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."

Should I Be Trying to Pass as Healthy?

By Crystal Lindell, PNN Columnist

Recently my new boyfriend told me he could tell from the moment he met me that I took pain pills.

“It’s all in the eyes. They look weathered. Mostly because the pain medications affect your sleep pattern.”

“Wait. What? What does that even mean? So I look old?”

“I think it’s really attractive actually.”

Sure. 

I was a bit devastated to find out that my elaborate efforts to convince the world that I am indeed quite healthy had failed me. So much for my $48 concealer from Ulta. 

The thing is I look young and I’m relatively friendly, so people usually can’t tell that I almost always feel like someone is repeatedly breaking my ribs. And I confess that I often use this to my advantage. People at work are on a need-to-know basis.

Until I met my boyfriend, I rarely told guys about my chronic pain. And when I’m at professional events it never comes up.  Sometimes I feel a little guilty about this, as though I’m somehow reaping the benefits of being able-bodied while my actual body is falling apart.

Looking healthy means nobody ever questions my ability to get things done, show up or keep working.

But the other side of this is that when I actually need help, it’s a lot harder to get. Nobody wants to give up their seat in the waiting area for the young girl who looks like she could go out and run a marathon tomorrow. Well, fine, probably not a marathon, but I definitely look like I could easily walk a 5K.

And getting help lifting a bag, or even using a scooter at the store makes me look like I’m just some lazy blonde chick taking away benefits from the people who actually need them.

I recently covered three trade shows in three weeks for work, and the whole thing left me battered on the couch at home. But during that final week, when I finally was bold enough to just float the idea of using a scooter to get around, someone who doesn’t know about my health said, “Well that would be in poor taste.”

It’s so hard to know what to do in that moment. Do I verbally vomit up my medical history right then? Do I laugh like I’m embarrassed? Or do I just ignore it?

I chose to throw out a sentence about how I was actually in real pain and then dropped the conversation.

More moments like that are bound to come up though. And one day I will have to break down and actually use the scooter. When that happens, I’m sure I’ll get some nasty looks from people who just assume I’m too lazy to walk the trade show floor.

But I’m also sure that eventually people will be able to tell I’m sick just by looking at me. And honestly, I’m dreading that more.

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

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

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