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.”

Don’t Take Away Our Medicine

By Lynn Joyce, Guest Columnist

I am a 62-year-old woman who -- aside from my intensely painful back --- enjoyed a full life of work, swimming, going to the gym, outings to various places with my husband and friends, and running my household.

A few years ago, my back pain became so severe I had to move from my primary care doctor to pain management after all the solutions we tried, including physical therapy, various pain treatments, x-rays and MRIs could not diagnose or in the end treat me. I went to a doctor in Sarasota who gave me pain medicine. which helped a little. I also had several procedures under anesthetic, which again did not totally relieve the pain.

I was desperate, as I spent much of the day and night with ice packs on my back to ease the pain. My ordinary life went down the drain, my husband got fed up with me not being able to accompany him and looking after my home went downhill.

I cried as I went to bed early with a sleeping pill to take away the pain -- though this did not always work as the pain woke me up. I tried various types of pain medicine and the one that worked best was oxycodone.

Nearly a year ago my doctors finally found a combination of drugs that made me pain free and able to resume my normal life. I was ecstatic to be able to do all the things I enjoyed again and to be able to run my home and look after my family.

I then had a shock a month ago when my doctor told me that my medicine would have to be reduced. I had two tearful visits to his office, where he told me that starting July 1st I would receive only one oxycodone a day.  

LYNN JOYCE

My doctor knows that this is not even a therapeutic dose and yet is being forced to break his sacred oath to "First do no harm." After getting my life back, I was so upset that I would have to go back to my previous existence, where every day is full of pain and there is very little joy.

I am not a drug addict. I am a person that needs medication for a condition that curtails my enjoyment of life, just as much as another person who needs a drug to alleviate their condition or keep them alive. My doctor should be allowed and supported in the care of his patients, not vilified by government and media alike.

There are legitimate people who are truly suffering and need the medication that is being taken from them. I am one of these people -- the other side of this so-called crisis – and we are being ignored and used as scapegoats by the government.

I do not understand how such arbitrary, draconian laws can be passed in a modern society. This government’s heavy-handed solution to the "opioid crisis" is targeting the wrong people. We are not the ones selling drugs like fentanyl and heroin, we are just people with an illness. We are not lawbreakers, although some of us may be driven to escape the pain with illegal drugs or, in some tragic cases, suicide.

There are studies that totally refute the reasoning behind these opioid laws and guidelines, doctors who have tried to stop this from happening to their patients, and those who know the science and social reasons that show we are not the cause. We are not out there selling our drugs or "doctor shopping."

I see and read daily about politicians and stores that are jumping onto the false bandwagon to further their own careers and profits. Pharmacies that are too afraid or are taking a false moral stance about the prescriptions they will or won't fill.

There has been mishandling of prescriptions in the past, but systems have been put in place to remedy that. Yet the media screams about this person or that who has overdosed and stores like Walmart that will limit a person’s medication to seven days. I hope there are the few that get opioids for short term use if they need it, but they are not long-term pain sufferers who need their therapeutic doses daily to ameliorate their pain.

I have read that companies are being forced by the DEA to reduce their drug production so much that there are worries about hospitals not having enough to treat patients or with surgeries being delayed.

Those of us that need long term drug treatment are your family member, a friend, or a familiar stranger like the postal worker who you see every day. We are not the archetypal addict that people think of when the words “drug user” comes up. Think of a time in your life when you or someone you care about was in pain and were helped by medication to make it go away.

We have that pain every day and it doesn't go away without our medicine. The government or anyone else in a position of power who keeps on pushing this inhumane agenda should walk in our shoes for a day.

Lynn Joyce 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.

When Do Guidelines Become Guidelines?

By Marvin Ross, Guest Columnist

Blaming doctors for failing to prescribe to guidelines that did not exist is the latest in the strange research coming out on the use of opioid pain medication.

That was the case for a recent study led by Dr. Tara Gomes, Dr. David Juurlink and others at the Institute for Clinical and Evaluative Studies (ICES) in Toronto, Canada. Both of these authors have a long list of research reports on opioids and Juurlink was one of the central players in the development of the Canadian guidelines for prescribing opioids for non-cancer pain. Juurlink is also a board member of Physicians for Responsible Opioid Prescribing (PROP), which is notorious for their anti-opioid views.

This particular study, called “Clinical indications associated with opioid initiation for pain management in Ontario, Canada,” is published online in the journal Pain. Gomes and Juurlink set out to evaluate prescribing patterns for patients who are “opioid naïve” to see if their prescriptions complied with guidelines adopted in the U.S. and Canada. In many cases, they did not.

“The U.S. and Canadian clinical guidelines for prescribing opioids for chronic non-cancer pain suggest that doctors should avoid initiating opioids at daily doses above 50 MME,"  Gomes is quoted saying in an ICES press release.

"Our study found that nearly one-quarter of Ontarians taking an opioid for the first time received a daily dose exceeding this threshold, and for certain indications such as knee, hip and shoulder surgeries and Caesarean sections, the dose was even higher.”

Here is the problem with their work. Gomes and Juurlink looked at prescription opioid claims for over 650,000 people in Ontario from April 1, 2015 to March 31, 2016 and compared them to guidelines that did not exist during the study period.

They defined as inappropriate any initial opioid dose that exceeded 50 MME (milligram morphine equivalent) or had a duration exceeding 7 days’ supply.  According to their findings, 17 percent of the opioid prescriptions were for periods longer than 7 days and almost one quarter (23.9%) were for dosages over 50 MME. This prescribing, they said, was not in line with North American guidelines.

By guidelines, they mean the Centers for Disease Control and Prevention guidelines that were released on March 18, 2016 --- two weeks before the end of the study period. The U.S. guidelines have never been formally accepted in Canada, although they were used to help shape the Canadian opioid guidelines that were released in 2017, a full 13 months after the study period.

How can one say that doctors were not compliant with prescribing guidelines when those guidelines did not exist at the time they prescribed? Doctors may be very clever, but I do not know of any who are capable of abiding by guidelines that only exist in the future

Aside from the study being biased and wrong, the misleading findings were picked up and portrayed by several Canadian news outlets as another example of doctors fueling the so-called opioid crisis. The Ottawa online policy paper Ipolitics ran a story with the headline, “A quarter of prescription drugs in Ontario exceeded dosage guidelines.”

Dr. Gomes also appeared on a popular radio show in Toronto saying, “We’re not really aligned right now with the guidelines in Canada.”

I have filed a formal retraction request with Dr. Michael Schull, the CEO of ICES. Schull referred my complaint to Gomes herself, who replied via e-mail on May 17 with:

“Your point regarding the timing of the guidelines in contrast with the timeframe of our study is an important one, and one that we made sure to address through our communications related to this study. In particular, in our study, we speak to the evidence related to harm associated with opioid doses above 50MME as being a core reason why attention should be paid to the high proportion of new opioid patients who are exceeding these doses. It is not simply that these doses exceed thresholds now recommended in guidelines, but that they have been shown in the literature to be associated with considerable risk of harm. We therefore need to consider how to mitigate this harm whenever possible.”

I pointed out in my reply that neither the media reports nor the press release cautioned about the discrepancy between the study period and the release of the guidelines, and I requested a public clarification and retraction. Schull replied that you cannot retract a study just because someone disagrees with it.

This is more than a simple disagreement. You cannot compare apples to oranges as they did. Schull’s final e-mail to me was we will agree to disagree, and I should take it up with the editors of Pain. Francis Keele, the editor in chief of Pain, informed me via e-mail on May 26 that they will be looking into the matter.

Broadcaster Roy Green, who has taken up the defence of chronic pain patients in both the U.S. and Canada through his syndicated radio show, offered Gomes the opportunity to bring with her 3 medical doctors to have an on-air debate on her research with him and me. So far, she has refused to respond.

I did point out to her boss that she works at the expense of taxpayers and since she is willing to discuss her work with a journalist who knows little or nothing of the topic, she has an obligation to talk to us.

I am not holding my breath.

(Update: Mr. Ross has been informed by the editor of Pain that the Gomes study has been revised to clarify to that the CDC and Canadian opioid guidelines were not in effect during the study period.) 

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

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

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

Spinal Injection Bill Would Raise Healthcare Costs

By Pat Anson, Editor

Republicans and Democrats often claim that reducing the cost of healthcare is one of their major goals. But a bipartisan bill that is sailing through Congress with little debate will do just the opposite, raising the cost of some epidural, facet joint and other spinal injections used to treat pain by as much as 25 percent for Medicare beneficiaries.

Critics say the legislation is little more than a money grab by doctors who perform the procedures, under the guise of preventing opioid addiction.

The “Post-Surgical Injections as an Opioid Alternative Act” (HR 5804) is one of nearly 60 bills to combat the opioid crisis approved last week by the House Energy and Commerce Committee. It moves to the full House for a vote.

The bill would partially reverse a decision made by the Centers for Medicare and Medicaid Services (CMS) in 2016 to cut the Medicare reimbursement rate for epidurals and other injections.  The interventional procedures – which do not involve opioids -- can cost several hundred dollars per injection.

The American Society of Interventional Pain Physicians (ASIPP) lobbied unsuccessfully to get the reimbursement cuts overturned – until it found two Illinois Republican congressmen willing to sponsor HR 5804, Rep. John Shimkus and Rep. Raja Krishnamoorthi.

“We first went to the CMS, then HHS, with no success in reversing draconian cuts for interventional techniques. CMS and the administration told us that it requires an Act of Congress,” ASIPP says on its website. “As a first step toward this, Shimkus and Krishnamoorthi have introduced H.R. 5804, which reverses some of the cuts for Ambulatory Surgery Center procedures. This is only the beginning. We have many other cuts to be reversed.”

According to OpenSecrets.org, Shimkus and Krishnamoorthi have both received $10,000 in campaign donations from ASIPP. The organization has spent over $500,000 on lobbying and donations so far in the 2017-2018 election cycle.

‘I Find It Hard to Trust CMS’

Shimkus introduced the ASIPP bill on May 15th and two days later helped shepherd it through its first and only hearing before the House Energy and Commerce Committee.

During the hearing, Shimkus claimed that by cutting the cost of spinal injections, CMS created a disincentive for doctors to perform the procedures and encouraged them to prescribe opioids instead.

“A lot of us were surprised to see CMS reduce the reimbursement rate for non-opioid pain treatments like epidurals for post-surgery pain,” Shimkus said. “I find it hard to trust CMS when those of us in this arena think their cut has led to more opioid use.

“A lot of us believe the inability to use epidurals to treat pain and prescribe opioids is not healthy for our country.”

To be clear, the CMS reimbursement cuts do not prevent any doctor from performing injections – it only made the shots less profitable. And Shimkus offered no evidence that the lower reimbursement rates encourage more opioid use – although he convinced many of his colleagues that they did.  

“I do think it's important in this crisis to be specific with CMS to make sure that we are not discouraging the use of non-opioid alternatives based on reimbursement-related issues,” said Rep. Larry Bucshon, MD (R-IN), who is a cardiologist. “In my experience over the years, CMS makes reimbursement decisions based on the financial incentives to do so, not necessarily, in my opinion, based on what is the appropriate therapy.”

“I don't agree that epidurals are not an alternative (to opioids) already. They are. They are. I just had a conversation with a surgeon about that. So that's not so,” said Rep. Anna Eshoo (R-CA).  “Imagine being able to manage pain without taking an opioid. We could do 20 other things together and it wouldn't equal that."

Rep. Frank Pallone (D-NJ) wasn’t buying any of it.

“I don’t think we have gotten any objective criteria to suggest that what CMS did is going to lead to more people taking opiates,” Pallone said. “I don't think there is any evidence to suggest that this legislation will lead to decreased opioid prescribing or a decreased prevalence of addiction.

“I think we are setting a bad precedent with the bill. I don't think that we, as Congress, are in a good position to pick and choose winners amongst therapies and procedures. I just don't think we know enough to understand the consequences of doing that to understand the relative value and the efficacy of different therapies and procedures on the market.”

Despite those concerns -- and after just 30 minutes of debate that included no public testimony -- committee members overwhelmingly supported the bill by a vote of 36 to 14. Nine Democrats joined with all Republicans on the committee in voting yes.

“What we are doing is temporarily reversing cuts to non-opioid treatment that we all agree save money and lives, then collecting to help ensure we are reimbursing providers at the most appropriate levels possible,” Shimkus said.

“That’s ASIPP talking,” says Terri Lewis, PhD, a researcher and longtime advocate for the pain community. “What does Shimkus know? Shimkus doesn’t know anything. There is no data to support that.”

Health Risks of Spinal Injections

There was no discussion by the committee about the effectiveness of epidurals and other spinal injections -- or of the health risks associated with their use.

Epidural injections have long been used to relieve pain during childbirth, but they are also increasingly being used to treat back pain, despite reports there is little evidence the shots are effective.

The FDA has also warned that the use of steroids in spinal injections – a procedure that’s never been approved by the agency -- “may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

“Here we have a procedure that they’re trying to slip under the swimming pool fence that is not FDA approved, that relies on materials that are not regulated and/or contraindicated, and they’re trying to pull a fast one. And they could very easily do it in this climate of opioid hysteria,” said Lewis.

As PNN has reported, some pain management experts believe spinal injections are overused – in part because they’re more profitable for doctors than using opioids or other procedures.  

“Probably everything that gets compensated well is over-utilized because it’s the compensation system. It’s a reimbursement system that pays more for treatment procedures than outcomes,” said Lynn Webster, MD, a past president of the American Academy of Pain Medicine.

A 2012 report by the General Accounting Office – a report requested by Rep. Pallone – found that unsanitary injection practices in ambulatory care clinics expose thousands of patients every year to blood borne pathogens such as hepatitis and HIV.  A perfectly sanitary needle can also go astray and puncture sensitive membranes in the spinal cord, leaving patients with serious and sometimes permanent injuries.      

“When it comes to spinal injections after surgery the risk to the patient, related to adverse events, increases substantially because spine surgery comes with risks of dural tears and accidental cuts,” says Terri Anderson, a Montana woman whose spine was damaged after receiving steroid injections for a ruptured disc in her back.  She now suffers from adhesive arachnoiditis, a chronic inflammation in the spinal membrane that causes severe pain.

“It is unconscionable that harmful injections would be pushed on unsuspecting pain patients,” Anderson said in an email to PNN. “It looks like the large hospital corporations and interventional pain professional societies have been busy lobbying our congressional representatives.  Apparently our healthcare system has become a profitable venture that indirectly contributes to many election campaigns in the U.S.”

No date has been set for a full House vote on HR 5804. To become law, it must pass both the House and Senate and then be signed by President Trump.  There is little opposition to the bill because many critics only recently learned that it was even being considered by Congress. 

“If this is allowed to stand, we have a problem,” says Lewis. “Another thing is Congress directing the practice of medicine. We’ve had just about enough of that.”