A Nightmare Experience With Surgery

By Rochelle Odell, Columnist

I have been warning my “healthy” family and friends that the opioid epidemic and the backlash against prescription opioids would affect them at some point. My recent nightmare of a surgery may prove that the time may now be at hand. 

On February 2, I underwent what normally would be minor surgery to remove a catheter -- called a portacath -- that had become dislodged. For patients with Complex Regional Pain Syndrome (CRPS), there is no such thing as a minor procedure and my experience became a prime example of what could go wrong.

My friend Debbie drove me to the hospital where the surgery was performed. I have undergone over 40 procedures for CRPS and I always become apprehensive, as any patient facing surgery should be. I told Debbie I did not have a warm toasty feeling about the surgery. I was frightened, a feeling I don't usually experience. But this time I did.

Before I was taken back to pre-op, Debbie asked me if I would like to pray. Thankful for the thought, I responded yes. It did not alleviate the feeling of dread nagging at me, but I hoped God would protect me.

Once in pre-op, the nurse went over my extensive allergy list. Believe me, it's long. I am allergic to almost all antibiotics, including penicillin, along with some opioids like Demerol and methadone, as well as aspirin and NSAID's. Betadine causes blisters and a horrible rash. I’m also allergic to most medical tape, including cloth, plastic, silk and paper tapes. The only one I can tolerate is Hypafix. It's a soft adhesive that allows the skin to breathe. I was very vocal about that.

The nurse asked what kind of surgery I was about to undergo and why. I told her it was because I don't have any good veins, never have, and that a catheter was a necessary evil. Without one, if I were to pass out or become very ill, dying could be a real possibility.

I told her she would only got two tries for the IV line I would need for surgery. I am not a pin cushion and multiple needle pricks could cause a major pain flare. She started the IV on the second try.

The surgeon and anesthesiologist then came to see me. I explained how nervous I was and that I honestly was very close to walking out. I should have done that. I could tell the surgeon had no clue what CRPS was or how to treat me post-op. That is not unusual, a lot of doctors have no clue what it is, and that extra steps are needed to keep a major pain flare from happening.

Even the anesthesiologist seemed clueless about CRPS. I thought that odd, since anesthesiologists are often pain management physicians. He kept telling me don't worry, once in the operating room I would be out soon.

Four hours later I was taken to the operating room. I told the anesthesiologist that I forgot to add fentanyl to my allergy list. It gives me a smothering feeling and can't breathe. I also told him I wanted an LMA mask, because being intubated causes my asthma to flare. He told me he would use the mask, but he wanted to use fentanyl and that if I stopped breathing he would intubate me.

What is wrong with this explanation? Use something other than fentanyl and you won't have to intubate me. I also asked the surgeon to place me on IV antibiotics, as I have a long history of staph and MRSA infections.

Upon coming out of anesthesia, my throat was killing me. I knew he must have intubated me and used a drug I didn't want. The pain was excruciating. I was given small doses of Dilaudid and oxycodone, which did absolutely zip for me.

They also gave me IV Tylenol. Really, Tylenol post-op in a CRPS patient? The recovery room nurse was trying to console me as I was in tears.  Any nurse I dealt with said they were trying to make sure I didn't die of an opioid overdose. That took the cake, the minuscule doses I received were obviously not working, so an opioid overdose certainly would not happen.

One nurse told me my pain was emotional pain. I should have screamed at her to get away from me, but I was in so much pain I couldn't think clearly. I was kept for observation overnight, which brought more problems and the realization that the very thing I warned my healthy family and friends about was indeed at hand.

What kind of pain control do patients get now after surgery?  My surgeon was responsible for ordering all my meds, but how is a man who has no clue what CRPS is going to manage my pain? A man I had only seen one time before the surgery.

My RN was very sweet, but she too was stating what I think must be the hospital's policy. They do not want to provide opioid pain management.  Everyone is so convinced the opioid epidemic was and is caused by prescription opioid medication. It dawned on me, ignorance is alive and well and it must be contagious.

My ordeal continued to worsen. I looked at my surgery sites. Not only were my upper chest and right arm covered in the tell-tale orange color from Betadine, but there was medical tape. A big painful and very itchy rash had developed.

My skin was driving me nuts. I asked the nurse to remove the tape and use non-stick pads and Hypafix, but she refused. Didn't anyone read my allergy list? Why ask for one if you are going to ignore it? The surgeon ordered Benadryl cream for my arm. It helped a little and I did get one injection of IV Benadryl, but that was it. I received less medication in the hospital than I was taking at home.

After a long painful night, I told the nurse I would refuse to see the surgeon. Anyone who causes a patient as much pain as he did is one I will not see again. The nurse said he had to see me in order to release me. I told her to tell him to have a different doctor release me, as I did not want to see him. I was livid. The morning I was released I removed the tape, as I could no longer tolerate it. She helped me cover the area with sterile gauze.

As soon as I got home I cleaned the surgery area thoroughly and made an occlusive dressing over the two surgical sites. The next morning my whole upper right chest was covered with tiny blisters and a nasty looking rash. My friend took pictures for me.  The asthma flare I was afraid of was in full swing and I was running a temperature of 102.  I could barely breath and my pain was completely out of control.

I had a temperature for three weeks, and six weeks later I am still coughing up yellow gunk. That could have easily been prevented, but what do I know, I am just the patient.  Because I refused to see the surgeon for a post-op checkup, my primary care provider sent me a letter informing me I was trying to direct my care and was argumentative. He would only treat me for 30 more days and I needed to find a new primary care physician.

In the past I might have been upset with a letter like that, but since this opioid epidemic has affected me so negatively, I simply do not want to be seen by any physician who doesn't try to understand how sick I am. I was in so much pain.  Wouldn't you try to direct your care at that point?

My ordeal has not ended. As of this writing, the whole port area and catheter tubing are swollen and look infected. Have I gotten it checked yet? Nope. I have literally been frozen in place by fear, a fear I have never experienced before. I know this will require more surgery to remove and replace the portacath. Just thinking about it scares me.

All of this could have been avoided if my allergy list had been read, if there had been adequate pain management, and if IV antibiotics had been started. If this is the future of medical care, I may reconsider seeing any doctor. It just isn't worth the stress and pain.

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

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

Trump Calls for More Cuts in Opioid Prescriptions

By Pat Anson, Editor

President Trump is calling for further reductions in the prescribing of opioid pain medication and for some drug dealers to get the death penalty.

In a speech in Manchester, New Hampshire, a state hit hard by the overdose epidemic, Trump outlined his plan to combat the nation’s opioid and addiction crisis by cracking down on drug dealers, opioid manufacturers and doctors who overprescribe pain medication.

“We’re going to cut nationwide opioid prescriptions by one third over the next three years,” Trump said. “We’re also going to make sure that virtually all prescriptions reimbursed by the federal government follow best practices for prescribing. We’ll ensure that opioid addiction is not subsidized by the American taxpayer. The best way to beat the drug crisis is to keep people from getting hooked on drugs to begin with.”

The president did not spell out precisely how opioid prescribing would be reduced. His administration has proposed new rules that would make it harder for Medicare beneficiaries to obtain high doses of opioid medication by rigidly adhering to the CDC’s voluntary opioid prescribing guidelines. Under the Medicare plan, insurers could refuse to pay for opioid prescriptions that exceed the dose levels recommended by the CDC.

Opioid prescriptions peaked in 2010 and the Drug Enforcement Administration has cut opioid production quotas nearly in half over the last two years – which has led to shortages of pain medication at some hospitals and hospices.  

The president also said the nation “must get tough” with high volume drug traffickers.

“The ultimate penalty has to be the death penalty,” Trump said. “Drug traffickers kills so many thousands of our citizens every year and that’s why my Department of Justice will be seeking much tougher penalties than we’ve ever had. And we will be focusing on the penalty that we talked about previously for the big pushers, the ones that are really killing so many people.

"Whether you are a dealer or doctor or trafficker or a manufacturer, if you break the law and illegally peddle these deadly poisons, we will find you, we will arrest you, and we will hold you accountable."

Trump said tougher border security was needed to stop the flow of illegal drugs and called for an nationwide advertising campaign to encourage children to avoid drug use.

“Spending a lot of money on great commercials showing how bad it is,” he said.

Last October, the president declared the opioid crisis a public health emergency, a designation that stopped short of the national state of emergency sought by his opioid commission. Critics have said the Trump administration has done little to fund or execute a coherent strategy to combat the overdose problem. 

Prescription Opioids Rarely Lead to Heroin Use

By Roger Chriss, Columnist

A recent Politico column by three anti-opioid activists asserts that “opioid use disorder is common in chronic pain patients”  and that the nation’s overdose crisis “stems largely from the overprescribing of opioids.”

Andrew Kolodny, MD, Jane Ballantyne, MD, and Gary Franklin, MD --  who are the founder, president, and vice-president, respectively, of Physicians for Responsible Opioid Prescribing (PROP) – also wrote that “many individuals become addicted to prescription opioids through medical or non-medical use, and then switch to heroin after becoming addicted."

This claim is an oversimplification of the tragedy that is heroin addiction. It both ignores the complex trajectory of drug use that culminates in heroin and omits the known risk factors of the people who suffer from heroin addiction. It also runs counter to the known data about various forms of opioid addiction, which clearly shows that most people on opioid therapy do not develop problems with misuse, abuse or addiction, and rarely move on to heroin.

The National Institute on Drug Abuse (NIDA) estimates that about 10 percent of patients prescribed opioids develop an opioid use disorder. And only about 5 percent of those who misuse their medication ever make the transition to heroin.

Further, the number of people addicted to prescription opioids -- about two million -- has been stable for over five years, while rates of heroin use have been rising, suggesting there is not a strong corelation between the two.

From 2002 to 2016, the number of Americans using heroin nearly tripled, from 214,000 to 626,000. Overdose deaths involving heroin also soared during that period.

The reasons behind this are complex and not fully understood. One theory is that heroin became more popular when prescription opioids became harder to obtain and abuse. According to a study by the RAND Corporation, the introduction of abuse-deterrent OxyContin in 2010 was a major driver in the shift to heroin.

Heroin use is also strongly associated with mental illness and childhood trauma. Studies have found that 75 percent of people with heroin addiction have another mental illness, with about half showing signs of psychiatric problems or post-traumatic stress disorder (PTSD) before age 16. At least half were abused or neglected as children, with especially high rates of sexual abuse.

In addition, it is well established in psychiatry that certain mental health disorders – such as borderline personality and bipolar disorder -- have a significantly increased risk of substance use.

Thus, heroin use and addiction is far more complex than just a result of opioid misprespcribing. Most people placed on opioid therapy do not misuse their medication, and the few who do become addicted rarely transition to heroin. Recent studies also suggest that more people are starting on heroin without prior exposure to other opioids.

Heroin addiction is most often the tragic outcome of a shattered childhood or mental illness, and not simply a result of medication exposure. To claim that heroin addiction stems largely from pain management is a disservice to both addicts and pain patients, and will only further the suffering of both groups by diverting attention from the real issues.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Hospital Opioid Shortages Cause Pain & Medical Errors

By Pauline Bartolone, Kaiser Health News

Even as opioids flood American communities and fuel widespread addiction, hospitals are facing a dangerous shortage of the powerful painkillers needed by patients in acute pain, according to doctors, pharmacists and a coalition of health groups.

The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine, Dilaudid and fentanyl — drugs given to patients undergoing surgery, fighting cancer or suffering traumatic injuries. The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production.

As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently. That raises the risk of mistakes — and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices, which works with health care providers to promote patient safety.

In the institute’s survey of hospital pharmacists last year, one provider reported that a patient received five times the appropriate amount of morphine when a smaller-dose vial was out of stock. In another case, a patient was mistakenly given too much sufentanil, which can be up to 10 times more powerful than fentanyl, the ideal medication for that situation.

In response to the shortages, doctors in states as far-flung as California, Illinois and Alabama are improvising the best they can.

Some patients are receiving less potent medications like acetaminophen or muscle relaxants as hospitals direct their scant supplies to higher-priority cases.

Other patients are languishing in pain because preferred, more powerful medications aren’t available, or because they have to wait for substitute oral drugs to kick in.

The American Society of Anesthesiologists confirmed that some elective surgeries, which can include gall bladder removal and hernia repair, have been postponed.

In a Feb. 27 letter to the U.S. Drug Enforcement Administration, a coalition of professional medical groups — including the American Hospital Association, the American Society of Clinical Oncology and the American Society of Health-System Pharmacists — said the shortages “increase the risk of medical errors” and are “potentially life-threatening.”

In addition, “having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients,” the group wrote.

The shortages involve prefilled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids.

Drug shortages are common, especially of certain injectable drugs, because few companies make them. But experts say opioid shortages carry a higher risk than other medications.

Small Mistakes Lead to Big Errors

Giving the wrong dose of morphine, for example, “can lead to severe harm or fatalities,” explained Mike Ganio, a medication safety expert at the American Society of Health-System Pharmacists.

Calculating dosages can be difficult and seemingly small mistakes by pharmacists, doctors or nurses can make a big difference, experts said.

Marchelle Bernell, a nurse at St. Louis University Hospital in Missouri, said it would be easy for medical mistakes to occur during a shortage. For instance, in a fast-paced environment, a nurse could forget to program an electronic pump for the appropriate dose when given a mix of intravenous fluids and medication to which she was unaccustomed.

“The system has been set up safely for the drugs and the care processes that we ordinarily use,” said Dr. Beverly Philip, a Harvard University professor of anesthesiology who practices at Brigham and Women’s Hospital in Boston. “You change those drugs, and you change those care processes, and the safety that we had built in is just not there anymore.”

Chicago-based Marti Smith, a nurse and spokeswoman for the National Nurses United union, offered an example.

“If your drug comes in a prefilled syringe and at 1 milligram, and you need to give 1 milligram, it’s easy,” she said. “But if you have to pull it out of a 25-milligram vial, you know, it’s not that we’re not smart enough to figure it out, it just adds another layer of possible error.”

During the last major opioid shortage in 2010, two patients died from overdoses when a more powerful opioid was mistakenly prescribed, according to the institute. Other patients had to be revived after receiving inaccurate doses.

Pfizer Manufacturing Problems

The shortage of the three medications, which is being tracked by the FDA, became critical last year as a result of manufacturing problems at Pfizer, which controls at least 60 percent of the market of injectable opioids, said Erin Fox, a drug shortage expert at the University of Utah.

A Pfizer spokesman, Steve Danehy, said its shortage started in June 2017 when the company cut back production while upgrading its plant in McPherson, Kansas. 

The company is not currently distributing prefilled syringes “to ensure patient safety,” it said, because of problems with a third-party supplier it declined to name.

That followed a February 2017 report by the U.S. Food and Drug Administration that found significant violations at the McPherson plant. The agency cited “visible particulates” floating in the liquid medications and a “significant loss of control in your manufacturing process [that] represents a severe risk of harm to patients.” Pfizer said, however, that the FDA report wasn’t the impetus for the factory upgrades.

Other liquid-opioid manufacturers, including West-Ward Pharmaceuticals and Fresenius Kabi, are deluged with back orders, Fox said. Importing these heavily regulated narcotics from other countries is unprecedented and unlikely, she added, in part because it would require federal approval.

DEA Reduced Opioid Supply

At the same time, in an attempt to reduce the misuse of opioid painkillers, the Drug Enforcement Administration called for a 25 percent reduction of all opioid manufacturing last year, and an additional 20 percent this year.

“DEA must balance the production of what is needed for legitimate use against the production of an excessive amount of these potentially harmful substances,” the agency said in August.

When the coalition of health groups penned its letter to the DEA last month, it asked the agency to loosen the restrictions for liquid opioids to ease the strain on hospitals.

The shortages are not being felt evenly across all hospitals. Dr. Melissa Dillmon, medical oncologist at the Harbin Clinic in Rome, Ga., said that by shopping around for other suppliers and using pill forms of the painkillers, her cancer patients are getting the pain relief they need.

Dr. Shalini Shah, the head of pain medicine at the University of California-Irvine health system, pulled together a team of 20 people in January to figure out how to meet patients’ needs. The group meets for an hour twice a week.

The group has established workarounds, such as giving tablet forms of the opioids to patients who can swallow, using local anesthetics like nerve blocks and substituting opiates with acetaminophen, ketamine and muscle relaxants.

“We essentially have to ration to patients that are most vulnerable,” Shah said.

Two other California hospital systems, Kaiser Permanente and Dignity Health in Sacramento, confirmed they’re experiencing shortages, and that staff are being judicious with their supplies and using alternative medications when necessary.

At Helen Keller Hospital’s emergency department in Sheffield, Ala., earlier this month, a 20-year-old showed up with second-degree burns. Dr. Hamad Husainy said he didn’t have what he needed to keep her out of pain.

Sometime in January, the hospital ran out of Dilaudid, a drug seven times more potent than morphine, and has been low on other injectable opioids, he said.

Because Husainy’s patient was a former opioid user, she had a higher tolerance to the drugs. She needed something strong like Dilaudid to keep her out of pain during a two-hour ride to a burn center, he said.

“It really posed a problem,” said Husainy, who was certain she was in pain even after giving her several doses of the less potent morphine. “We did what we could, the best that we could,” he said.

Bernell, the St. Louis nurse, said some trauma patients have had to wait 30 minutes before getting pain relief because of the shortages.

“That’s too long,” said Bernell, a former intensive care nurse who now works in radiology.

Dr. Howie Mell, an emergency physician in Chicago, said his large hospital system, which he declined to name, hasn’t had Dilaudid since January. Morphine is being set aside for patients who need surgery, he said, and the facility has about a week’s supply of fentanyl.

Mell, who is also a spokesman for the American College of Emergency Physicians, said some emergency departments are considering using nitrous oxide, or “laughing gas,” to manage patient pain, he said.

When Mell first heard about the shortage six months ago, he thought a nationwide scarcity of the widely used drugs would force policymakers to “come up with a solution” before it became dire.

“But they didn’t,” he said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

What the JAMA Opioid Study Didn’t Find

By Roger Chriss, Columnist

A recent opioid study published in the Journal Of the American Medical Association (JAMA)  evaluated pain management in patients with hip and knee osteoarthritis and low back pain.

The study by VA researcher Erin Krebs, MD, and colleagues found that “treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months.”  

That finding was widely and erroneously reported in the news media as meaning that opioids are ineffective for all types of chronic pain.

But the most fascinating result of the study – the one not being reported -- is what wasn’t found. The 108 people in the study who took opioids for a year did not develop signs of opioid misuse, abuse or addiction, and did not develop opioid-induced hyperalgesia – a heightened sensitivity to pain.

And no one died of an overdose.

This is significant because it runs counter to commonly held beliefs in the medical profession about the risks of prescription opioids. Here are a few recent examples:

“Opioids are very addictive and their effectiveness wanes as people habituate to the medication,” Carl Noe, MD, director of a pain clinic at the University of Texas Medical Center wrote in an op/ed in The Texas Tribune.

Don Teater, MD, a family physician in North Carolina, also believes that people on long-term opioid therapy experience dose escalation, which leads to hyperalgesia. “Opioids cause permanent brain changes,” Teater told USA Today.

Krebs herself has made similar comments. "Within a few weeks or months of taking an opioid on a daily basis, your body gets used to that level of opioid, and you need more and more to get the same level of effect,” she told NPR.

But the Krebs study didn’t see any of that happen.

Krebs and colleagues closely monitored the 108 people in the opioid arm of the study, using “multiple approaches to evaluate for potential misuse, including medical record surveillance for evidence of ‘doctor-shopping’ (seeking medication from multiple physicians), diversion, substance use disorder, or death.” They also had participants complete the “Addiction Behavior Checklist” and assessed their alcohol and drug use with surveys and screening tools.

What did Krebs find in the opioid group after 12 months of treatment?

“No deaths, ‘doctor-shopping,’ diversion, or opioid use disorder diagnoses were detected,” she reported. “There were no significant differences in adverse outcomes or potential misuse measures.”

Health-related quality of life and mental health in the opioid group did not significantly differ from the non-opioid group – and their anxiety levels actually improved.  

These are observational findings in the study. They were not a part of what Krebs and colleagues were specifically trying to measure. As the study notes: “This trial did not have sufficient statistical power to estimate rates of death, opioid use disorder, or other serious harms associated with prescribed opioids.”

ERIN KREBS, MD

But they are valuable observations. They note what didn’t happen in the study. Over 100 people were put on opioid therapy for a year, and none of them showed any signs of dose escalation or opioid-induced hyperalgesia, or any evidence of opioid misuse, abuse or addiction.

Krebs told the Minneapolis Star Tribune that this “could reflect the fact that the study did not enroll patients with addiction histories, and because the VA provided close supervision to all participants during the yearlong study.”

In other words, Krebs and colleagues used an opioid prescribing protocol that achieved an admirable level of patient safety. Their approach is similar to what many pain management practices currently pursue and what the CDC and various state guidelines recommend: Risk assessment before initial prescribing and careful monitoring over time.

The Krebs study provides rare and detailed observations of what happens when people are put on long-term opioid therapy. A lot of what is claimed about dose escalation, opioid-induced hyperalgesia, and misuse or abuse didn't happen at all.

This outcome demonstrates that long-term opioid therapy can be safe and effective, and may be useful in treating other chronic conditions, from intractable neuropathies to painful genetic disorders. That’s worth reporting too, isn’t it?

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Overuse of Acetaminophen Increases During Flu Season

By Pat Anson, Editor

Acetaminophen is a key ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – from Excedrin and Tylenol to Theraflu and Alka-Seltzer Plus.

Recent guidelines released by the UK’s National Institute for Health Care Excellence (NICE) even recommend acetaminophen (paracetamol) for treating sore throat pain.

But a large new study warns that too many cold and flu sufferers take too much acetaminophen – which has long been associated with liver damage and allergic reactions such as skin rash.

Researchers at the University of Pittsburgh and Boston’s University’s Slone Epidemiology Center surveyed nearly 14,500 U.S. adults about their use of acetaminophen in the preceding 30 days. The study, which was sponsored by Johnson & Johnson, was conducted over a five-year period, from 2011 to 2016.

Investigators found that 6.3% of acetaminophen users exceeded the recommended maximum adult daily dose of 4,000 mg on at least one day during a week that they used acetaminophen.

Usage patterns grew during the cold and flu season. The odds of taking more than 4,000 mg of acetaminophen increased to 6.5% compared to 5.3% during the off-season.

This was primarily due to increased use of over-the-counter medications designed to treat upper respiratory cold and flu symptoms.

"This is the first multi-year, year-round study that includes detailed data on how consumers used acetaminophen medications," said Saul Shiffman, PhD, of Pinney Associates and the University of Pittsburgh. "The study findings suggest the importance of educating consumers about acetaminophen and counseling them about appropriate use and safe dosages of these medications.

"Getting this message out is especially important during cold/flu season, when people may be more likely to treat illness symptoms with acetaminophen combination products, sometimes without even realizing they contain acetaminophen."

The use of acetaminophen (paracetamol) is even more pronounced in France, according to a new study published in the British Journal of Clinical Pharmacology.

There was a 53% increase in the use of paracetamol in France between 2006 and 2015, and 1000 mg tablets of paracetamol (which are not available in the United States) are now the most-used drug among French adults. There is also a trend towards larger doses. Consumption of 1000 mg tablets increased by 140 percent in France over the ten-year study; while consumption of 500 mg tablets decreased by 20 percent.

Compared to other countries in Europe, France ranked first in paracetamol usage and third in the consumption of mild opioids such as tramadol and codeine. The French use of strong opioids such as morphine was among the lowest in Europe.

"To our knowledge, this is the first published study analysing consumption trends for both non-opioids and opioids over the last decade in France. Long-term surveillance over the past 10 years has highlighted quantitative and qualitative changes in analgesic consumption patterns in France," said study co-author Philippe Cavalié, PhD, of the French National Agency for Medicines and Health Products Safety.

"The very widespread analgesics consumption that we have documented raises the concern of overuse and misuse, as well as addiction to opioids."

The U.S. Food and Drug Administration asked drug makers in 2011 to limit acetaminophen doses to 325 mg per tablet or capsule. The FDA also requires a “Boxed Warning” label – the agency’s strongest warning – to call attention to serious risks.

Over 50 million people in the U.S. use acetaminophen each week for pain and fever – many unaware of the risk of liver injury and allergic reactions. Over 50,000 emergency room visits each year in the U.S. are blamed on acetaminophen overdoses, including 25,000 hospitalizations and 450 deaths.

For more information about acetaminophen and how to avoid overdosing, visit KnowYourDose.org.

It's a Myth America Consumes 80% of World’s Opioids

By Roger Chriss, Columnist

Getting the facts right about the opioid crisis is essential. And the claim that the United States consumes 80% of the world’s supply of opioid medication -- while having only 5% of the world’s population -- is incorrect.

This “80/5” claim is popular and persistent. Senator Claire McCaskill tweeted about it last year. Recently Consumer Safety and the Reporter Newspapers repeated it. And news organizations like The Guardian, Business Insider, CNN and ABC News have all reported the “80/5” claim as fact at various times. 

The truth is that Americans consumed only about 30% of the world’s opioid medication in 2015. And the U.S. has about 4.4% of the world’s population.  That's still a lot, but nowhere near "80/5."

So where does the claim that the U.S. consumes 80% of the world’s opioids come from? It took a little digging to find out.

In 2014, Nora Volkow, MD, director of the National Institute on Drug Abuse, submitted the following testimony to the U.S. Senate Caucus on International Narcotics Control:

"The number of prescriptions for opioids (like hydrocodone and oxycodone products) have escalated from around 76 million in 1991 to nearly 207 million in 2013, with the United States their biggest consumer globally, accounting for almost 100 percent of the world total for hydrocodone (e.g., Vicodin) and 81 percent for oxycodone."

A footnote reveals where Volkow got that information. It came from a 2008 report from the International Narcotics Control Board, which states:

“In 2008 the United States accounted for over 99 per cent of the global consumption of hydrocodone and 83 per cent of the global consumption of oxycodone.”

This ultimately seems to be the origin of the “80 percent” part of the claim. At one time, the U.S. was responsible for over 80% of the world’s consumption of one particular type of opioid medication: oxycodone.

But the numbers vary significantly for each type of opioid. According to the Global Commission on Drugs, the U.S. consumed 57.3% of the world’s morphine in 2013. And Statista reports that in 2015 the U.S. consumed 29.3% of the world’s supply of prescription fentanyl, followed closely by Germany at 23.7 percent.

The U.S. at one time did consume 99% of the world’s supply of hydrocodone. But as a Pain Medicine article by Mark Rose explains, that is because “other countries with adequate opioid access prefer dihydrocodeine or low-dose morphine to hydrocodone for moderate to moderately severe pain.”

Hydrocodone prescriptions have actually plummeted in the U.S. since 2014, when it was rescheduled by the DEA as a Schedule II controlled substance.

So what are the real numbers for opioid consumption?

As Politifact notes while debunking McKaskill’s “80/5” claim, “while the United States is clearly the largest consumer of opioids, it, at most, accounts for roughly 30 percent of global consumption.”

At present, however, there are opioid shortages in some hospitals and hospices. The Philadelphia Inquirer recently reported that morphine, hydromorphone (Dilaudid), and fentanyl — staples of pain control and sedation in hospital settings — are in short supply.

“The shortage of hydromorphone is beyond acute,” Beverly Philip, vice president of scientific affairs for the American Society of Anesthesiologists, told the Inquirer.

The shortage is due, in part, because the DEA has lowered annual production quotas for fentanyl, hydromorphone, and morphine over the last two years by 35 to 46 percent.

This demonstrates the risk of persistent false claims. As Sally Patel, MD, wrote in an excellent Politico piece about the opioid crisis: “We need to make good use of what we know about the role that prescription opioids plays in the larger crisis.”

Otherwise we’ll find ourselves awash in a false narrative while enduring very real pain.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Is JAMA Opioid Study Based on Junk Science?

By Pat Anson, Editor

You may have read about a research study published this week in the Journal of the American Medical Association (JAMA), which compared the effectiveness of opioid and non-opioid medications in treating chronic pain. 

The yearlong study of 240 patients found that opioids were not superior to pain relievers like acetaminophen and ibuprofen in treating chronic back pain or hip and knee pain caused by osteoarthritis.  Pain improved for 41% of the patients who took opioids, compared to 54% in the non-opioid group.  

It’s an interesting study – one of the few to look at the effectiveness of any pain relievers long term – but some critics are questioning the study’s methodology and the alleged anti-opioid bias of its lead author, Erin Krebs, MD, a researcher for the Department of Veterans Affairs.

First let’s look at some of the news coverage the study is getting.

“Opioids Don’t Treat Chronic Pain Any Better Than Ibuprofen” reads the headline in Newsweek, an article that never mentions the JAMA study was limited to patients with back pain or osteoarthritis.

“Opioids Don’t Beat Other Medications for Chronic Pain” was the headline in NPR.com, while the Chicago Tribune went with “Opioids no better than common painkillers for treating chronic pain.”

The Tribune article included a quote from one of the co-authors of the CDC opioid guidelines. "The fact that opioids did worse is really pretty astounding," said Roger Chou, MD. "It calls into question our beliefs about the benefits of opioids."

Notice the news coverage strongly suggests that opioids are ineffective for all types of chronic pain – not just back pain and osteoarthritis.  Patients living with chronic pain from arachnoiditis, trigeminal neuralgia or some other intractable pain condition would probably disagree about that. And they'd find the idea of taking ibuprofen laughable, if not infuriating. But no one asked for their opinion.

Also unmentioned is that opioids are usually not prescribed for osteoarthritis or simple back pain, which are often treated with NSAIDs and over-the-counter pain relievers.

So, what JAMA has published is a government funded study designed to look at a treatment (opioids) that most people with back pain and arthritis never actually get.

“You've been had by anti-opioid advocates disguising their advocacy as science.  Krebs is well known in professional circles for this kind of distorted advocacy junk science,” wrote patient advocate Red Lawhern, PhD, in a comment submitted to the Philadelphia Inquirer after it published a misleading headline of its own, “Prescription opioids fail rigorous new test for chronic pain.”

“I suggest that you retract your article.  In its present form, it is propaganda not fact,” said Lawhern, a co-founder of the Alliance for the Treatment of Intractable Pain (ATIP). “Opioids have never been the first-line medical treatment of choice in lower back pain or arthritis. That role is served by anti-inflammatory meds, some of them in the prescription cortico-steroid family.  NSAIDs have a role to play, recognizing that they are actively dangerous in many patients if taken at high doses for long periods.  Hundreds of people die every year of cardiac arrest or liver toxicity due to high-dose acetaminophen or ibuprofen.” 

Who is Erin Krebs?  

Dr. Krebs is an associate professor at the University of Minnesota Medical School and a prolific researcher at the VA Medical Center in Minneapolis.

She was also an original member of the “Core Expert Group” – an advisory panel that secretly drafted the CDC’s controversial opioid guidelines while getting a good deal of input from the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). The guidelines recommend that opioids not be prescribed for chronic pain.

Krebs also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Some of her previous opioid research has been controversial. In a study published last year in the Annals of Internal Medicine, Krebs reviewed 67 studies on the safety and effectiveness of opioid tapering. Most of the studies were of poor quality, but nevertheless Krebs came to the conclusion that pain levels and the quality of life of patients “may improve during and after opioid dose reduction.”

ERIN KREBS, MD

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms,” wrote Krebs.

PROP founder Andrew Kolodny, MD, read the review and liked it, tweeting that “dangerously high doses should be reduced even if patient refuses.”

But forced opioid tapering is never a good idea, according to a top CDC official.

“Neither (Kreb’s) review nor CDC's guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial also published in the Annals of Internal Medicine. 

As for Krebs’ contention that there is “insufficient evidence” of adverse events associated with opioid tapering, that notion may be put to rest next month when the VA releases a new study showing that tapering has led to a growing number of suicides by veterans.

In a summary of the findings, which will be presented at the Rx Drug Abuse & Heroin Summit, VA researchers report that “opioid discontinuation was not associated with overdose mortality, but was associated with increased suicide mortality.”  

Who and what should we believe in the neverending debate about opioids? PNN columnist Roger Chriss wrote about Krebs’ opioids vs. non-opioids study last year, when the initial reports of its findings came out. Roger said prescribing decisions are best left to physicians who know their patients’ medical conditions – not researchers, regulators or the news media.

“In reality, there is no ‘versus’ here. Opioids and NSAIDs are both valuable tools for chronic pain management. To pretend that one is inherently better than the other is to miss the essential point: Both work and should be available for use as medically appropriate,” Roger wrote. 

CDC: Emergency Room Overdoses Up Sharply

By Pat Anson, Editor

Emergency room visits for opioid overdoses have soared by 30 percent in 16 states, according to a new Vital Signs report by the Centers for Disease Control and Prevention. The CDC called the report a “wake-up call to the fast-moving opioid overdose epidemic.”

Between July 2016 and September 2017, there were over 142,000 suspected opioid overdoses treated in hospital emergency rooms in the 16 states. Overdoses increased for men and women in all age groups, in all regions of the country, and in rural and urban areas.

The new report does not specify how many patients died or if the overdoses involved prescription opioids or illegal opioids like heroin and illicit fentanyl. A previous report by the CDC indicated that over half the nation’s fatal overdoses are now linked to fentanyl, a synthetic opioid increasingly available on the black market.

“Long before we receive data from death certificates, emergency department data can point to alarming increases in opioid overdoses,” said CDC Acting Director Anne Schuchat, MD. “This fast-moving epidemic affects both men and women, and people of every age. It does not respect state or county lines and is still increasing in every region in the United States.”

Ten of the 16 states studied had significant increases in emergency room overdoses, with the number of overdoses in Wisconsin up by an alarming 109 percent.  Opioid overdoses in Delaware also doubled.

Midwestern states saw the biggest increase overall, with a 70% increase in overdoses, followed by the West (40%), Northeast (21%), Southwest (20%) and Southeast states (14%).

Overdoses declined by 15% in Kentucky, and by smaller amounts in Massachusetts, New Hampshire and Rhode Island. Schuchat said the decline could be related to the increased availability of drugs like naloxone, which can rapidly reverse the effects of an opioid overdose.

Failure of Opioid Guidelines Ignored  

The Vital Signs report did not examine the apparent failure of the CDC’s opioid prescribing guidelines to have any impact on the overdose rate. The agency's controversial guidelines were not even discussed during a 30-minute briefing Schuchat had with reporters today.

Since the CDC guidelines were released in March 2016, many pain patients say their opioid doses have been reduced or eliminated, and the quality of their pain care has deteriorated. Some patients abandoned by doctors are having trouble finding new ones willing to treat them.

A recent report from the Massachusetts Department of Public Health found that prescription opioids were involved in only about 15% of the fatal overdoses in 2017, while fentanyl was involved in 83 percent of the opioid deaths in that state.

Critics Pan Medicare Plan to Reduce High Dose Opioids

By Pat Anson, Editor

Over 1,200 people have left public comments in the Federal Register about changes to Medicare's Part D prescription drug plan, most of them sharply critical of rules that would make it harder for Medicare patients to obtain high doses of opioid pain medication.

Under the proposed regulations for 2019, a ceiling for opioid doses would be set at 90mg morphine equivalent units (MME) for all Medicare beneficiaries.  Any prescription at or above that level would trigger a “hard edit” rule requiring pharmacists to talk with the insurer and doctor about the appropriateness of the dose – with the insurer being the final arbiter in deciding who gets the higher dose.  

If adopted, critics say the rule would force many high-dose opioid patients to be abruptly tapered to lower doses, causing severe pain and withdrawal symptoms -- and possibly leading to illegal drug use and suicide.

“Suddenly dropping opioid doses will cause acute opioid withdrawal, exacerbation of pain, and increased disability with decreased productivity. It also increases the risk that patients will migrate to riskier alternatives such as heroin or fentanyl,” wrote David Kan, MD, an addiction psychiatrist.

“The proposed rule change is in the right spirit but very, very risky in reality. I urge CMS to reconsider the arbitrary dose limit on opioids. The unintended consequences are potentially devastating to our patients and community.”

“This is archaic medicine and does more harm than one can imagine,” wrote pain patient Henry Yennie. “The DEA, HHS, private insurers, and now CMS are pursuing policies and restrictions that will cause harm and suffering to millions of people... You are complicit in the pain, suffering, and documented damage that will result.”

“I cannot understand how Medicare can be so uncaring about the pain people have,” wrote Mikal Casalino, a 72-year old pain patient. “Limiting the dosage to an arbitrary amount is not going to be helpful for individuals. Each person who needs medication deserves the best care possible, and that will depend on both condition and need.”

“I think it is absolutely ludicrous to imagine that a third party could presume to place a maximum daily or monthly limit on my, or any other chronic pain patient's, medication. Each person's tolerance for and requirement of medication varies tremendously. How could you possibly imagine that you could come up with a generic formula which could fit every chronic pain patient across the board?” wrote Cyrynda Walker.

A joint letter opposing the rule change was submitted by 180 doctors and academics, including some who assisted in drafting the CDC’s controversial 2016 opioid prescribing guidelines. The letter points out that a 48 percent reduction in high dose prescribing since 2010 has not reduced the number of opioid overdoses. And it faults CMS for being focused on reducing high dose prescriptions – not the quality of patient care.

“The proposal does not consider adverse impacts on pharmacies, physicians or patients in the context of multiple regulatory initiatives, and it will accelerate patient abandonment,” the letter warns. “The plan avows no metric for success other than reducing certain measures of prescribing. Neither patient access to care nor patient health outcomes are mentioned.”

The public comment period on the CMS proposal ended March 5. To see the comments that were posted, click here.

CMS Seeking ‘Dialogue’ About Opioids

According to CMS, 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. Medicare officials said the goal of the “hard edit” rule is to get pharmacists, doctors and insurers to “engage in a dialogue” about the risks associated with high dose opioid prescriptions.

"We are proposing important new actions to reduce seniors' risk of being addicted to or overdoing it on opioids while still having access to important treatment options," said CMS deputy administrator Demetrios Kouzoukas in announcing the rule changes last month. “We believe these actions will reduce the oversupply of opioids in our communities."

To reduce the risk of “unintended consequences” from the hard edit rule, CMS would allow high dose patients to receive a temporary 7-day supply of opioids while they seek an exception to the 90mg MME rule. If approved, patients would then need to get a new prescription from their doctor. The 7-day supply would only be granted once.

Under the proposed rules, CMS would also create a new 7-day limit for initial prescriptions of opioids for acute, short-term pain. CMS would also start monitoring “high risk beneficiaries” who are prescribed opioids and “potentiator” drugs such as gabapentin (Neurontin) and pregabalin (Lyrica). Recent research has shown that combining the medications increases the risk of overdose.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

Unless changes are made, the proposed Medicare Part D rules for 2019 will be finalized April 2.

A Canadian Asks ‘Where the Hell Am I?’

By Ann Marie Gaudon, Columnist

I hear more and more stories like Elizabeth Matlack’s, a lifelong chronic pain sufferer who recently wrote about her problems getting adequate pain medication in Canada. (See “Who Benefits From My Suffering?”).

Not only do I live in a chronically pained body, I feel pain for her. I feel pain for all of those who struggle each and every day, who are now being medically abandoned. Imagine, the only thing any of them has ever done is to end up with a pained body. As I read these stories, there seems to be no stem to the flow. I am beginning to ask myself, “Where the hell am I?”

Just like Elizabeth, I am also Canadian. All my life I’ve lived here and felt so grateful for it. All my life I basically felt safe. I felt secure. I felt that my needs were looked after. I was damned proud of our medical system too. From a blood test to chemotherapy, whatever might come my way, I had faith that I’d be cared for and that I wouldn’t have to claim bankruptcy to get it.

I’ve known for many years that treatment for chronic pain has always been woefully inadequate. I held out hope that good people with good intentions would come to care about this too. In a safe place like Canada, surely it was just a matter of time.

Then I was aghast and insulted to hear that our very own prime minister said that chronic pain was “low grade, but very annoying.” In a cooperative place like Canada, surely someone will educate him to let him know the degree of suffering, disability and high rate of suicidality chronic pain patients have.

ANN MARIE GAUDON

Won’t noble physicians with an intense desire to ease that suffering and do justice to their oaths come soon to advocate for us and improve our care? As I look around today, not seeing a trace of this, I am forced to ask myself, “Where the hell am I?”

I’ve lived enough years to know that people don’t generally do things for no reason and the reasons are plentiful. Money, fame, prestige, power, a moral sense of self-righteousness; there are a lot to choose from. Who benefits from a fabricated war on defenseless chronic pain patients while chasing the wrong crisis with a boat load of unproven assumptions?

Somebody somewhere does. You can be sure that there are too many hands in too many pockets to count. They all knew that chronic pain patients would be collateral damage, but the one thing they all have in common is they just don’t care.

Our Canadian government willingly let this happen under the disingenuous guise of “we have to protect you from your pain medications.” Imagine, you’ve been stable with nature’s gift of the most effective medication for your severe pain and now you can’t have it.

No Opioids Webinar

On the same day as I read about Elizabeth, I watched a webinar about how to treat chronic pain without opioids. The narrator was a physician who reportedly specialized in chronic pain. He was very efficient with his colour-coded columns of the categorizations of diseases and which treatments were suited to each.

Then something caught my eye. I noticed a chronic disease called interstitial cystitis was grouped together with pain central sensitization disorders. In bold font on the chart for this group was written: “NO Opioids!!”

Ironically, a few days before this, I was contacted by a woman diagnosed with this very disease. She was admitted into a hospital, where she emailed me. She wrote that a scope into her bladder revealed mass inflammation and lesions that the urologist described as “looking like cigarette burns throughout her bladder.” Her body was breaking down. Too much pain for too long. She was admitted with excessive sweating, soaring blood pressure, fever, and shaking uncontrollably.

It's likely her fight-or-flight response had become pathological in the face of intolerable, relentless pain. I have recently read that unrelieved pain complicates all other co-existing conditions through these stress mechanisms. She is also diabetic.

What would those who promote Canada’s new opioid guidelines -- which have made a mockery of chronic pain – suggest for this woman?  Would she be offered chiropractic care to make her right as rain? Perhaps Advil because that has an anti-inflammatory in it?

The webinar doctor made jokes along the way, such as “No one ever died from mindfulness.” So maybe we’ll start with meditation. She can’t think straight right now? Then maybe she should try yoga on her stretcher.

What became crystal clear watching the webinar is that these people don’t know a damned thing about chronic pain, especially severe pain. But so much worse yet – they don’t care to know -- so long as they get to pontificate about the demon opioid medication and the demons who have been taking them.  

The reality is that this woman has a significant risk of being dead soon. We know the guidelines have already played an unspeakable part in the deaths of chronic pain patients in the way of medical collapse and suicide. But no one seems to care about that either.

This isn’t the place that I grew up in. This isn’t the place where I felt safe, secure and cared for. This is an immoral place where those at the top serve their own political agenda. Yes, I said political because there’s no medical facts driving this out-of-control freight train.

This is an unethical place where the suffering are drop-kicked off a cliff and where the self-righteous and self-serving call down, “It sure sucks to be you.”

I don’t recognize Canada anymore. I’ve never lived in a place with such cruelty inflicted on such a vulnerable group. I didn’t grow up in a place with such a pervasive ultra-conservative meanness, where those in power exclusively serve themselves and to hell with the underdog – let them suffer until the bitter end.

Who benefits from Elizabeth’s suffering? Somebody somewhere does. As for the Canada I used to know and love, I can no longer see it or feel its reassurance. I guess I’ll have to continue to ask, “Where the hell am I?”

Because at this point, I just can’t figure it out.

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.

Opioids, Fentanyl and Medical Malpractice

By Jennifer Kilgore, Columnist

One night in 2016, Richard Goldblatt had an acute pancreatitis attack.

“I was sitting at home, and all of a sudden I had this God-awful pain that wouldn’t go away,” he told us. The pain was so bad that at the time, I thought someone had stabbed me!”

His wife and oldest son brought him to the nearest emergency room, where medical professionals examined him, gave him something for the pain and asked him for his medical history. Richard told them he had recently removed a melanoma spot on his left shoulder, had a complete right knee replacement in 2002, and rectal repair in 2006, which had caused permanent nerve damage around the scar and, curiously, in both feet. He’d been in terrible pain ever since.

At first, he did receive opioid medication capable of quelling his nerve pain – though that didn’t last. Richard kept asking his surgeon why his feet hurt if he’d had rectal repair, as it made no sense.

“He [the doctor] kept telling me it was hemorrhoid pain, and he didn’t know why my feet were hurting all the time. I didn’t find out what really happened until around 2009 or 2010, when I was finally seen by a neurologist and examined properly. He told me that the surgeon knew he’d made an error. That being said, I have suffered ever since. I was also told it was too late to have any recourse in regard to that doctor.”

Richard started seeing a pain specialist, who tried all sorts of treatments – nothing helped. They even introduced him to the most radical of treatments: the fentanyl patch.

The fentanyl transdermal patch is meant for people who have tried other opioid or narcotic medications and need something much, much stronger. This provides around-the-clock pain relief for 72 hours in the form of a skin patch that allows medication to sink directly into the bloodstream and absorb quickly.

The list of warnings for the patch is long and thorough. Don’t take other medications with the patch. Don’t drink alcohol while using the patch. Don’t use the patch except exactly as directed by your doctor.

Richard did all of those things… and he still had problems.

“Yes, it eventually helped,” he said. “Yes, it did calm and deaden the pain… [but] I was never told about the basic warnings… I found out the hard way.”

Richard did not abuse fentanyl. But, as it turned out, heat – body heat, in the case of Richard – affects the use of the patch and causes it to absorb more quickly into the bloodstream. Fentanyl patch doses are meant to last for 72 hours. Richard’s high body temperature ensured that the patch would only last one or two days.

Richard ended up in the emergency room three different times in 2017 because of withdrawal, as his body heat caused the patch to absorb medication more quickly into his body, leaving him without more Fentanyl to sustain him over the lifetime of the patch. Neither his pain management specialist nor the emergency room doctors, however, realized this at the time.

Meanwhile, after the acute pancreatitis episode, Richard began to rapidly lose weight, which made little sense because he was still hungry and eating food. Doctors put him through the paces, making him take blood tests, MRIs, CT scans, ultrasounds – all of which came back clear.

“I was led to believe that everything was back to normal,” Richard said. “I was discharged with that idea and instructed that I could go back to my life as if nothing had happened. I was back at the ER in a week.”

His frustrations were mounting. This time he was told it was gastroenteritis and that he had a list of allergies. Richard already knew he was allergic to wheat and shellfish, so this was no surprise. He just wanted to know why he felt so awful and why he kept losing weight.

He was having new symptoms, too – he noticed an oily yellow discharge that smelled absolutely foul. When he informed his doctors, they prescribed Creon, a medication intended for exocrine pancreatic insufficiency, or EPI. This means your body is missing important enzymes it needs to digest food, and nutrients are passing through the body unabsorbed, which would explain why he was losing so much weight even though he was eating food. However, at the time, he was on such a low dose of Creon that it didn’t seem to be working.

Richard met with another gastroenterologist who wanted to do an endoscopic ultrasound, but his insurance wouldn’t cover it. Then another doctor wanted to cut out his gallbladder. Another wanted to put him on Cymbalta – “I told him, ‘No thanks.’ No more drugs in my system.”

By that time, Richard had lost almost 60 pounds. The case manager in charge of his file finally managed to get him to a doctor who could think outside of the box and diagnosed him with exocrine pancreatic insufficiency, which is what the Creon medication should have helped.

There was still a missing piece to the puzzle, however. The cause of his troubles? Opiate use.

According to his doctors, the fentanyl he was prescribed for his progressive nerve pain aggravated an underlying pancreatic condition. As EPI is normally caused by genetics, behavior or malnutrition, it only made sense that Richard’s opiate use, which at that time was in such high dosages, threw his body into high gear and revolted against him.

Weaning off Fentanyl

Fentanyl withdrawal should be done under the supervision of a medical professional. It is an extremely addictive medication because of its euphoric tendencies, which can make users compulsive and need more to get the same effect. However, withdrawing from it properly can minimize symptoms.

Patients might supplement their withdrawal program with methadone or buprenorphine, which can lessen the severity of symptoms. A doctor might simply taper the fentanyl, however, which is weaning the patient off until they are no longer taking it. Many users require an in-patient program to succeed. Symptoms of Fentanyl withdrawal can include nausea, vomiting, increased pain, chills, irritability, stomach cramps and more.

When Richard asked his doctor’s thoughts about weaning him off fentanyl use, the doctor told him in an email that “opiates cause or aggravate a severe form of irritable bowel and will aggravate any pancreas condition you have.”

Now Richard is trapped in a physical hell against a national medical backdrop that could not be more against him.

The fentanyl patch regimen he has been prescribed is aggravating his congenital pancreatic condition, and he cannot treat one without denying the other. If he chooses a lesser opioid, his progressive nerve pain will spike and leave him unable to physically function. If he uses fentanyl, it inflames his damaged pancreas.

Meanwhile, the statute of limitations has run out against his surgeon, depriving him of judicial remedies – as lawyers have already informed him.

“I’ve been turned down a couple times,” he said.

It is a difficult climate right now in the medical field, with the opioid crisis raging across the country and even legitimate fentanyl patch doses that are clearly not abuse being regarded with suspicion.

The Drug Enforcement Administration raided the office of a prominent pain management physician, Dr. Forest Tennant, the day after he testified as an expert in a negligent homicide case. Other physicians are tapering their patients or having them sign pain contracts, even though they are clearly suffering on their regimens.

Then there are patients like Richard, who have medications that they need, but have suffered at the hands of doctors’ ineptitude. And who is going to pay once the statute of limitations has run out?

“I guess I’ll have to wait until I’m dead and some researcher can have my pancreas examined to prove my point,” Richard said. That is the only thing he says he can look forward to, “as this disorder will eventually kill me.”

In January 2018, Richard let us know his new pain management specialist ordered him to withdraw from the fentanyl, as prescribing that medication was “against his principles.”

On the plus side, four days into the withdrawal (“which was complete hell,” Richard said), his pancreas started producing the necessary digestive enzyme again. Fentanyl had suppressed his pancreas’ ability to work and made him too sensitive to medications. Now that he’s gone cold turkey, he is able to eat properly – but suffers from intractable nerve pain.

“I have been told that recovering from this trip into hell could take a very long time,” Richard said. The only question is whether he can handle the pain until he fully recovers.

This article originally appeared in Enjuris and is republished with permission.

Jennifer Kain Kilgore is an attorney editor for both Enjuris 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.  

Bill Would Create 3-Day Limit on Opioids for Acute Pain

By Pat Anson, Editor

A bipartisan bill has been introduced in Congress that would impose a national 3-day limit on opioid prescriptions for acute short-term pain and authorize another $1 billion to subsidize the addiction treatment industry.

The CARA 2.0 Act is a follow-up to the Comprehensive Addiction and Recovery Act of 2016. It is sponsored by four Democrats and four Republicans: Senators Rob Portman (R-OH), Sheldon Whitehouse (D-RI), Amy Klobuchar (D-MN), Maria Cantwell (D-WA), Shelley Moore Capito (R-WV), Dan Sullivan (R-AK), Maggie Hassan (D-NH), and Bill Cassidy (R-LA).

“The opioid epidemic truly is a national crisis that is affecting families and communities across the country, and in West Virginia, we’ve become far too familiar with its consequences,” Sen. Capito said in a statement. “While we’ve accomplished a lot in terms of drawing attention to the drug epidemic and providing resources to help address it, it’s painfully clear that we still have a long way to go and need to be doing even more.

Several states have already enacted measures to limit opioid prescriptions for acute pain – usually limiting them to five or seven days’ supply. CARA 2.0 would make a 3-day limit mandatory nationwide for “pain with abrupt onset and caused by injury or other process that is not ongoing.”

The bill would exempt patients with chronic pain and cancer, as well as those in hospice and palliative care. It is not clear how the 3-day limit would apply to patients recovering from surgery or for those whose pain lasts longer than 3 days.

Under the bill the U.S. Attorney General would be authorized not to renew or register the licenses of physicians to prescribe controlled substances if they do not abide by the initial 3-day limit.

It also requires doctors to consult with the prescription drug monitoring database (PDMP) in their state before writing a prescription for a controlled substance to make sure a patient isn’t already getting opioid treatment. Prescribers who repeatedly fall “outside of expected norms or standard practices” would be reported to law enforcement and their state licensing boards.

The latter provision was initially proposed by Sen. Cassidy under the Protection from Overprescribing Act.

"I’m glad the Protection from Overprescribing Act is included in this bill, so law enforcement gets the information they need to identify providers who are overprescribing and fueling this crisis,” said Cassidy, who is a licensed physician.”  “In Louisiana, there is about one opioid prescription for every person. I and other physicians took an oath to first, do no harm. Some doctors are selling these prescriptions for profit. This is doing harm and it must be stopped.”

If passed, the bill raises the penalty for opioid manufacturers who fail to report suspicious orders for opioids from $10,000 to up to $500,000.

States would be allowed waive the limit on the number of patients a physician can treat with buprenorphine (Suboxone), an addiction treatment drug. There is currently a cap of 100 patients per physician.

The bill also seeks to create a national network of addiction treatment facilities, to be funded by $200,000,000 in grants annually from 2019 to 2023. The grants would only be available to large non-profit treatment programs that already have facilities nationwide, such as Phoenix House. 

Sessions Creates New Task Force to Target Rx Opioids

By Pat Anson, Editor

U.S. Attorney General Jeff Sessions has announced the creation of a new task force targeting manufacturers and distributors of opioid pain medication, as well as physicians and pharmacies engaged in the “unlawful” prescribing of opioids.

“We are attacking this crisis at its root: the diversion and overprescription of opioid painkillers,” Sessions said at a news conference. “We will use criminal penalties.  We will use civil penalties.  We will use whatever tools we have to hold people accountable for breaking our laws.”

Sessions also said the Justice Department would file a “statement of interest” in hundreds of lawsuits filed by states, counties and cities seeking to recover billions of dollars in damages from opioid manufacturers who used deceptive marketing practices. Such a statement could result in the federal government joining as a party in the lawsuits and recovering damages.

Sessions said the government had borne “substantial costs” as a result of the opioid crisis, including $4 billion paid by Medicare for opioid pain medication in 2016.

“The hard-working taxpayers of this country deserve to be compensated by those whose illegal activity contributed to those costs.  And we will go to court to ensure that the American people receive the compensation they deserve,” Sessions said.

“These are not our last steps.  We will continue to attack the opioid crisis from every angle.  And we will continue to work tirelessly to bring down the number of opioid prescriptions, reduce the number of fatal overdoses, and to protect the American people.”

Sessions’ announcement avoided any mention of the growing scourge of black market opioids, such as heroin, illicit fentanyl and counterfeit medication, which are now responsible for most overdose deaths. He also did not acknowledge that opioid prescribing has been declining for several years and that less than one percent of legally prescribed opioids are diverted.

The new task force – called the Prescription Interdiction & Litigation (PIL) Task Force -- will include senior officials from the Attorney General’s Office and the Drug Enforcement Administration. It appears to be focused solely on prescription opioids.

“The PIL Task Force will use the criminal and civil tools available under the Controlled Substances Act against doctors, pharmacies, and others that break the law,” the DOJ said in a statement.

Sessions directed the task force to improve coordination with the Department of Health and Human Services – which includes the FDA, CDC and the Centers for Medicare and Medicaid Services (CMS) – in sharing healthcare data to identify “patterns of fraud related to the opioid epidemic.”

The Attorney General's single-minded focus on pain medication as the cause of the opioid crisis has angered many pain patients and advocates.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a speech earlier this month. "People need to take some aspirin sometimes and tough it out.”

“I hope Sessions falls down, hits his head and breaks a hip and has to take two aspirin and get over it,” wrote one PNN reader.

“Jeff Sessions is an instrument of hate. He has succeeded in driving a wedge through the most sacred trusts -- the relationships between doctors and patients. Doctors now fear and loathe their patients for putting their licenses at risk, and patients fear and loathe their doctors for abandoning their compassionate care plans,” wrote another reader.

"This is exactly why we don't need, a group of people that know nothing about what they are making laws for. Jeff Sessions, if you or one of your family had Reflex Sympathetic Dystrophy, you would never have made a fool out of yourself with your aspirin remarks," said another.

Survey Finds Media Bias in Coverage of Opioid Crisis

By Pat Anson, Editor

Nearly two-thirds of health journalists believe the treatment of chronic pain is a major cause of the opioid epidemic, according to a new study that suggests many reporters are biased or ignorant about the true nature of the overdose crisis.

“The CNN Effect: The Mediaization of Pain Policy” was released by the PAINS Project, a coalition of patient advocates and pain management experts that seeks to make chronic pain a public health priority. “The CNN Effect” is a term first used in the 1990’s to describe the impact of 24-hour cable news on public policy.

“One of PAINS’ foundational working assumptions is that the media shapes public perception, public perception translates into votes, and votes equal public policy,” the PAINS report explains. “This theory can also be applied to public health policy related to both chronic pain and the opioid crisis.”

To test that theory, PAINS worked with Mugur Geana, PhD, a professor at the William Allen White School of Journalism at Kansas University, in a survey of over 1,000 health journalists who cover chronic pain or the opioid crisis.

While the response rate was low – only 193 reporters and editors completed the survey – the results do provide some insight into the mindset of journalists and how they cover opioid stories.

The survey’s major finding was that many journalists believe there is a direct relationship between chronic pain and opioid substance abuse – even though studies have shown that it is relatively rare for pain patients to become addicted. Sixty three percent of the journalists surveyed believe that chronic pain was a major cause of the opioid epidemic and over a third (36.5%) believe that overprescribing of opioids by doctors was the primary cause.

Most of those surveyed also believe that opioid abuse is a bigger public health problem than chronic pain, even though pain patients outnumber opioid abusers by a 50 to 1 margin.  Nearly 70% “strongly agree” that opioid abuse was a major problem, compared to less than half who think chronic pain is a major problem.

“Another interesting finding was the very low use of people living with chronic pain as drivers or main sources for stories - compared to medical and academic sources, for example. We keep hearing from patient advocates that their stories seldom make it above the fold (if they make it in the paper at all), and that was reflected in our findings,” Geana said in an email.

Asked what primary sources they used to prepare stories, about 70% of health journalists said they turned to “medical experts” and nearly half said they used local, state or federal agencies. Only about 20% said they used “anecdotal stories from patients” as a primary source.

“Of particular interest to PAINS was evidence that patients are not considered ‘expert’ resources by health journalists. People living with chronic pain seem to be approached only to provide illustrating examples for stories that are driven primarily by information from other published articles/stories, academic sources, and data provided by federal agencies,” the PAINS report found.

“Although the low response rate does not allow conclusive results, this study does imply a bias among healthcare journalists and the need for pain advocacy organizations to help those reporting on these issues to engage with articulate chronic pain patients who can relay their experiences in a way that journalists/reporters find authoritative. Otherwise, reporting on chronic pain and the opioid crisis will continue to be what could be called an ‘echo chamber.’”

The CNN Effect

One example cited by PAINS of the “CNN Effect” was a 60 Minutes report last year that was highly critical of a law passed by Congress that limited the ability of DEA agents to investigate companies that distribute pharmaceutical drugs. After the report aired, Sen. Claire McKaskill (D-MO) invited former DEA investigators who appeared in the 60 Minutes segment to speak at a roundtable discussion on the opioid issue with her Senate colleagues.

PAINS asked Sen. McCaskill and her staff to include medical experts and pain patients in the roundtable and was turned down.

“Initially, we were told that it was simply too close to the date set to extend additional invitations. PAINS sent her staff a list of five highly qualified individuals to participate in the roundtable and offered to facilitate their participation. In response, PAINS’ Director was invited to attend, contingent upon Senator McCaskill’s approval. Two days later the invitation was rescinded,” the PAINS report said.

McCaskill recently released a report that was sharply critical of patient advocacy groups and medical pain societies for accepting nearly $9 million in funding from opioid manufacturers. Among the groups mentioned was the Center for Practical Bioethics, a non-profit closely affiliated with the PAINS Project, which received $163,000 from opioid makers.

“These financial relationships were insidious, lacked transparency, and are one of the many factors that have resulted in arguably the most deadly drug epidemic in American history,” McCaskill's report alleges.

As PNN has reported, McCaskill has received over $6 million in campaign donations from law firms since 2005, including some currently involved in litigation against opioid manufacturers. According to OpenSecrets.org, contributors affiliated with the law firm of Simmons Hanly Conroy have donated over $300,000 to McCaskill, who is running for reelection this year.  

Simmons Hanly Conroy represents dozens of states, counties and cities that are suing Purdue Pharma and other drug makers over their marketing of opioids, and stands to pocket one-third of the proceeds from any settlement, according to reports.