Patient in Tulsa Hospital Shooting Was Angry About Pain Care

By Pat Anson, PNN Editor

The gunman who killed four people Wednesday at an Oklahoma hospital recently had back surgery and was angry about his post-operative pain not being treated, according to police and media reports.

Michael Louis shot and killed Dr. Preston Phillips, the surgeon who performed the operation, as well as another doctor, a medical receptionist and a bystander who took his wife to an appointment at Saint Francis Hospital in Tulsa. The 45-year-old Louis fatally shot himself as police closed in.

“What we currently know is that Louis was in pain, Louis expressed that he was in pain and was not getting relief and that was the circumstance surrounding this entire incident,” said Tulsa Police Chief Wendell Franklin. “He blamed Dr. Phillips for the ongoing pain that came from the surgery.”

Phillips was an orthopedic surgeon who specialized in spinal surgery and joint reconstruction. He graduated from Harvard Medical School in 1990.

No details have been released on what type of back surgery Louis had or what kind of pain medication he was given. According to a niece, he suffered from back pain for “a long time.”

“We are aware that he has been experiencing back pain for a long time but [there is] no reason for this senseless act,” the niece told The Daily Beast. “We are a Christian-based family. We have never experienced this before.”

Police say Phillips operated on Louis on May 19. Louis was released from the hospital on May 24, but called “several times over several days complaining of pain and wanted additional treatment,” according to Franklin. Louis had an appointment with Phillips on Tuesday, the day before the shooting, but it’s not clear if any further pain relief was offered to him.

In the days following his surgery, Louis was living in the home of his ex-wife, Dr. Edith Lubin, a family practice physician. Her lawyer released a statement saying Lubin had no knowledge of her former husband possessing a gun or having “any intent of harming anyone.”

“Dr. Lubin is praying for the families of all those affected. She acknowledges everyone’s concerns in understanding what happened, but she is at a loss for an explanation, other than the effect of continuing pain to Mr. Louis during his recovery,” the lawyer said in a statement to a KJRH-TV reporter.

Louis bought a handgun on Sunday and a semiautomatic rifle on Wednesday afternoon, just hours before the shooting. Both weapons were legally purchased, according to police.

Franklin said a letter found on Louis after the shooting “made it clear that he came in with the intent of killing Dr. Phillips and anyone who got in his way.”

Asked whether opioids were involved in Louis’ treatment, Franklin said investigators have only established that he was in pain and that other details about his care were still being investigated, according to The Washington Post.

‘Just a Matter of Time’

In recent years, many U.S. hospitals have stopped or reduced the use of opioids after surgery, fearing patients may become addicted. Non-opioid analgesics and over-the-counter pain relievers such as Tylenol are increasingly being used to treat post-operative pain.

"Out of all the hospital systems in Oklahoma, I have heard the most about the horrible pain treatment at St. Francis,” said Tamera Lynn Stewart, an Oklahoma patient advocate and Policy Director for the P3 Political Action Alliance. “I know so many who have had surgery there and received Tylenol only or who see doctors there that claim they aren’t allowed to prescribe." 

Opioid addiction is actually rare after surgery. Studies have found that less than 1% of patients are still taking opioids a year after major surgery or were later diagnosed with opioid dependence.  

With their pain poorly treated or left untreated, Stewart says some desperate patients in Oklahoma have threatened to kill themselves on the steps of the state capitol to make a statement. The mass shooting at the Tulsa hospital, while tragic, was not unexpected to her. 

“While our hearts are grieving with the families and victims, few in our grassroots communities built to advocate for appropriate treatment of pain without government or third-party interference can say this was completely unexpected. Veterans have committed suicide at VA’s across the country for the same reason,” Stewart told PNN. 

“Most of us knew it was just a matter of time before someone who could no longer bear the unrelenting pain did something more drastic in order to get the attention needed to end the restrictions (on opioids) and begin the much-needed process of swinging the pendulum back to a more neutral position.” 

Long before Tulsa, there were other cases where people in pain resorted to drastic action. In 2017, a man suffering from chronic back pain shot and wounded two people at a Las Vegas pain clinic before taking his own life.   

That same year, an Indiana doctor was fatally shot by a man who was upset because the physician refused to prescribe opioids to his wife, who suffered from chronic pain.

In Memory of Two Pain Warriors

By Pat Anson, PNN Editor

The pain community is mourning the loss of two of its most dedicated advocates this Memorial Day weekend: Terri Lewis and Jeffrey Fudin.

Dr. Fudin was a clinical pharmacist who specialized in pain management at the Stratton VA Medical Center in Albany, New York. He was also a prolific researcher, blogger and mentor to other clinicians. Fudin died Friday at the age of 63 after a lengthy battle with Stage 4 colon cancer.

Fudin spent much of the past year visiting with family and friends, displaying an extraordinary amount of courage, grace and humor as his prognosis worsened. He even managed to work a few laughs into his own obituary, which he penned himself.

“Seriously, you thought I was going to leave you all without a final post from the grave? If you’re reading this, I am now resting comfortably and hopefully watching over those I most cherished while on earth,” Fudin wrote.

“Someplace there is a lemon tree that will bear fruit from the earth. That sour fruit will provide joy and perhaps lemonade to those I leave behind.”

JEFFREY FUDIN

Terri Lewis’ battle with cancer was shorter and her passing unexpected. She died Saturday at the age of 70 from complications caused by chemotherapy for metastatic melanoma. 

Dr. Lewis was a rehabilitation specialist and educator who specialized in disabilities and mental health. She traveled regularly to Taiwan, where she was an Assistant Professor at National Changhua University of Education.

Lewis was a prolific researcher on issues affecting the pain community, which she shared freely with other advocates and reporters. She and Fudin helped me understand many complex issues when I first started covering pain management a decade ago.

“Terri was one of the most staggeringly intelligent people I have ever met. I remain in awe of her ability to identify and wrangle large data sets and to discern meaningful trends and relationships in healthcare processes with levels of complexity which overwhelm me,” said patient advocate Rose Bigham.

“She was generous with her time, coached and collaborated with many other pain patients and advocates, and was a fierce defender of her adult son who had been neglected and abused by multiple healthcare systems and providers due to his complex health conditions. She was relentless. She taught so many of us to never give up, and to be unafraid of tackling the big problems.”

TERRI LEWIS

“Terri Lewis was a force; her enthusiasm was inspiring, and I think that enthusiasm helped struggling patients keep hope alive and continue to fight, myself included. I am so grateful for all she taught me,” said Anne Fuqua. “There was one day where I was worried sick about a friend with muscular dystrophy who was on a ventilator. His physician had decided to take advantage of having him admitted for IV antibiotics and use this as an opportunity to taper his opioids and he planned to do this over the period of one week. Terri knew exactly who to ask for – and in less than 2 hours the taper was aborted.

“The very best those of us who loved Terri can do is to use what she taught us to help fellow patients as well as ourselves. I hope we can do a tenth the good she did in her lifetime.”

‘They Were Heroes’

It’s an overused expression, but Lewis and Fudin really were “pain warriors” who worked hard to dispel the many myths that surround the use of opioid medication. They risked their careers and reputations while opioid hysteria gripped the nation, patients were abandoned, and doctors were prosecuted for treating pain. When others looked away, Lewis and Fudin stood up to defend them.   

“They were heroes,” says Dr. Mark Ibsen, who fought to regain his medical license after he was suspended by the Montana medical board for “overprescribing” opioids.  

“Terri was a tireless and relentless advocate and teacher. She understood the malfeasance of targeting doctors by the abuse of dating mining,” Ibsen told PNN. “They use these data banks to predict diversion and prescribing ‘outside the usual course of medical practice’ even though nothing of the sort is proven.” 

Much of Fudin’s advocacy was focused on ending the “pseudoscience” of using morphine milligram equivalents (MME) to measure the risks and effectiveness of an opioid – which illogically presumes that every patient and every opioid are identical.

“Jeffrey Fudin debunked the false equivalency of MME levels, noting the bogus assertion that ‘one size fits all’ does not apply to the complexities of human biochemistry and pharmacology,” said Ibsen.  

Fudin’s funeral will be held on June 1 in Albany. In lieu of flowers, it was Fudin’s wish that any memorial tributes be made in the form of a tax deductible donation to the Dr. Jeffrey Fudin Memorial Foundation. 

A Terri Lewis Memorial has also been established at the Arachnoiditis & Chronic Meningitis Collaborative Research Network (ACMCRN), a non-profit that Lewis helped found and where she was VP of Research..

RIP Terri and Jeff.

Experimental Ketamine Pill Effective in Treating Acute Pain

By Pat Anson, PNN Editor

An experimental oral tablet that combines ketamine with aspirin was nearly as effective as an opioid in treating acute pain in emergency room patients, according to the results of a small pilot study.

Ketamine is a non-opioid analgesic that is also used to treat anxiety and depression. The drug is so potent, that it is usually administered by an infusion, injection or nasal spray under strict medical supervision. Some doctors and patients have also found ketamine effective as a treatment for certain chronic pain conditions.

“Ketamine has long been viewed as a highly promising analgesic, but its adverse effect profile, available routes of administration, and short-lasting effects limited its use. Our goal is to overcome all three of these limitations,” says Joseph Habboushe, MD, an emergency room physician and founder of Vitalis Analgesics.

Vitalis has developed a proprietary formulation of aspirin that delivers faster and stronger pain relief than traditional aspirin. The company is working to see if a combination of its aspirin with low-dose ketamine could be used to treat pain.

In the pilot study at Maimonides Medical Center in New York, 25 emergency room patients with acute musculoskeletal pain were given the ketamine-aspirin pill – called VTS-85. After an hour, their pain level scores were reduced an average of 3.8 points, pain relief similar to that of oxycodone-acetaminophen (Percocet) formulations, which reduced pain levels by 4.0 points in previous studies.

Researchers say the pain relief from VTS-85 lasted for two hours, with pain scores dropping an average of 4.4 points. Notably, only 4-8% of patients experienced the dissociation and sedation that is usually experienced when ketamine is administered intravenously.

“The results of this pilot study are highly encouraging, with pain reduction similar to studies using IV ketamine formulations but lasting longer and with lower side effects, and it’s oral,” said Habboushe.

The study findings are published in The Journal of Emergency Medicine.

“If proven in larger controlled trials, this could represent a breakthrough in the treatment of acute pain and a range of other indications,” said lead investigator Sergey Motov, MD, Department of Emergency Medicine, Maimonides Medical Center.

Vitalis has completed a second larger trial on the use of VTS-85 in emergency room patients, but the results have not yet been released. The company is also studying VTS-85 as a treatment for acute headache and postoperative pain. The ketamine-aspirin pill will require a prescription if approved by the FDA.

Pregnant Women Raise Risk of Complications by Using OTC Pain Relievers

By Pat Anson, PNN Editor

Pregnant women who take over-the-counter pain relievers are one-and-a-half times more likely to have complications, including stillbirth and premature delivery, according to a large new study.

Researchers at the University of Aberdeen analyzed data from over 151,000 pregnancies in the UK from 1985-2015, looking for medical notes indicating the women used paracetamol (acetaminophen), aspirin or the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, naproxen and ibuprofen — either alone or in combinations.

The findings, recently published in BMJ Open, show a significantly higher risk of a preterm delivery, neonatal death, low birth weight and other health problems in babies born to mothers who used OTC pain relievers. Neural tube defects of the brain, spine or spinal cord were 64% more likely; while hypospadias, a birth defect affecting the penis, was 27% more likely.

“Over-the-counter analgesics consumption during pregnancy was associated with a substantially higher risk for adverse perinatal health outcomes in the offspring. The use of paracetamol in combination with other non-steroidal anti-inflammatory drugs conferred the highest risk,” wrote lead author Aikaterini Zafeiri, PhD. “The increased risks of adverse neonatal outcomes associated with non-prescribed, over-the-counter, analgesics use during pregnancy indicate that healthcare guidance for pregnant women regarding analgesic use need urgent updating.”

One of the more surprising aspects of the study is how use of the five analgesics by pregnant women grew dramatically over the 30-year study period.  In 1985, only 1.8% reported using one of the pain relievers. By 2015, that had grown to 70.6% -- with most of the increase coming in the last seven years of the study.

Although it is believed to be one of the largest and most comprehensive studies of its kind, the research was limited. The duration, dose and stage of the pregnancy when analgesics were consumed were not recorded. The health of the mothers and babies later in life was also not studied.

But given the substantial increase in analgesic use during pregnancy and the higher risk of complications, researchers say more caution is needed on use of the drugs.

“The ease of access to non-prescription painkillers, in combination with availability of misinformation as well as correct information through the internet, raises safety concerns,” said Zafeiri. “It should be reinforced that paracetamol in combination with NSAIDs is associated with a higher risk and pregnant women should always consult their doctor or midwife before taking any over-the-counter drugs. We would encourage a strong reinforcement of the official advice for pregnant women.”   

Previous studies have linked prenatal use of paracetamol to autism, hyperactivity and behavioral problem in children. Despite the findings, drug regulators in the UK and US maintain that it is safe for pregnant women to use paracetamol (acetaminophen).

“Paracetamol is the first choice of painkiller if you're pregnant or breastfeeding. It's been taken by many pregnant and breastfeeding women with no harmful effects in the mother or baby,” the UK’s National Health Service (NHS) says on its website.

The Food and Drug Administration also does not caution pregnant women about using acetaminophen. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

Meanwhile, drug regulators in Australia are so concerned about recent deaths involving paracetamol that they may restrict access to the drug. Australia’s Therapeutic Goods Administration (TGA) has commissioned a report by an expert panel on the risks of paracetamol misuse.

“While paracetamol has well established safety and toxicity profiles, the wide use is paralleled by a high prevalence of accidental and deliberate paracetamol poisoning in the community, in both adults and children,” the TGA said in a statement earlier this month.

“The TGA is aware of concerns, particularly of families and healthcare professionals of affected consumers of paracetamol, regarding the number of poisonings and deliberate overdoses from paracetamol obtained from general retail outlets, and whether current access restrictions are appropriate.”

Australia currently regulates the quantity and dose of paracetamol sold over-the-counter. The independent commission will consider if stricter buying limits should be imposed. 

Class Action Lawsuit by Pain Patient Against CVS Moves Forward

By Pat Anson, PNN Editor

A federal judge has ruled that a class action lawsuit against CVS may continue over the pharmacy chain’s refusal to fill high dose opioid prescriptions for a Florida woman.

Edith Fuog, a breast cancer survivor who lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions, filed suit against CVS in 2020, alleging the company discriminated against her and violated the American with Disabilities Act (ADA). Her complaint was filed in federal court in Rhode Island, where CVS has its corporate headquarters.

The lawsuit alleges that CVS pharmacists refused to fill her opioid prescriptions nearly 30 times because the daily doses exceeded 90 morphine milligram equivalents (MME), a threshold considered risky under the 2016 CDC opioid guideline. Although the guideline is voluntary, many healthcare providers have adopted it as a mandatory policy.   

This week Judge William Smith rejected a CVS motion to dismiss the lawsuit, essentially ruling that because Fuog needed a higher dose to treat pain from her medical conditions, she was legally qualified as a disabled person.

“Ms. Fuog has pleaded sufficient facts for the Court to conclude that it is plausible that prescriptions over the threshold are generally denied meaningful access to this benefit, and also disproportionally or predominantly disabled,” Judge Smith wrote in his opinion.

“She has alleged a specific dose-and-duration threshold and provided well-pleaded facts supporting a strong correlation between those over the threshold and disability. While she will have much to prove as the case progressed, these pleadings push past the plausibility bar.”

Judge Smith agreed to drop CVS Caremark as a defendant in the lawsuit, saying there wasn’t a clear enough allegation against the company’s pharmacy benefit manager. But the rest of the potentially precedent setting case will continue.   

“He basically said there’s no doubt that she’s disabled. And there’s no doubt that there’s discrimination going on,” Fuog told PNN.  “It’s a huge step. And we’ve got all this in his own words, telling us this is real, it’s happening, it’s unfair and it’s discrimination.”

“We are very pleased with the Court’s ruling and look forward to moving ahead and litigating the claims on Edith’s behalf,” said Scott Hirsch, Fuog’s lawyer. “We are always happy to speak with other individuals who are being denied the filling of their legitimate opioid prescriptions. They can go to the website we have setup and get more information.”

Longtime Problem for Patients

Pain patients across the U.S. have complained for years about pharmacies refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and flimsy excuses about not filling a prescription, such as a pharmacist claiming a particular opioid was out of stock.

The CVS case and a similar lawsuit against Walgreen’s in California are believed to be the first class action cases to address the problem. Class action suits allow plaintiffs to prosecute a case in civil court and receive compensation for their injuries on behalf of others.

“I was thrilled with this opinion. I think it’s very well-reasoned and applies the ADA appropriately,” said Kate Nicholson, a civil rights lawyer who at one time worked for the Justice Department and helped draft federal regulations under the ADA. She is now Executive Director of the National Pain Advocacy Center (NPAC).

“I mean it’s ridiculous that this woman went to 30 different pharmacies and couldn’t get her prescription refilled. That is highly problematic,” Nicholson told PNN.

Ironically, CVS and several other pharmacy chains face multiple lawsuits for filling too many opioid prescriptions and allegedly contributing to the nation’s opioid crisis. CVS recently reached a $484 million settlement with the state of Florida to end opioid litigation there.

Pharmacists have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, but should first take steps to verify whether a prescription is legitimate and medically necessary, such as calling the prescribing doctor. Fuog’s lawsuit alleges that CVS pharmacists refused to call her doctor or even look at her medical records.

“Which is why I think the judge was very careful on this case to say CVS has a perfectly legitimate basis for looking at high dose prescribing,” said Nicholson. “They just can’t do it in this arbitrary way.”

Anti-Inflammatory Drugs May Contribute to Chronic Pain

By Pat Anson, PNN Editor

Anti-inflammatory drugs that are widely used to treat short-term acute pain disrupt the body’s natural healing process and increase the chances of developing chronic pain, according to a provocative new study by an international team of researchers.

If true, it means that ibuprofen, naproxen, diclofenac and other non-steroidal anti-inflammatory drugs (NSAIDs) used by millions of people every day for the temporary relief of acute pain may contribute to long-term pain that is even harder to treat.    

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs. But we found that this short-term fix could lead to longer-term problems,” said co-author Jeffrey Mogil, PhD, Professor of Pain Studies and the Canada Research Chair in the Genetics of Pain at McGill University in Montreal.

In a series of studies, Mogil and his colleagues first analyzed genes and immune cells in the blood of 98 patients with acute lower back pain (LBP), noting which patients became free of pain and which ones developed chronic pain after three months.  

In patients who became pain free, there was an early inflammatory response to acute pain that activated neutrophils -- a type of white blood cell that helps the body fight infection.

In patients with chronic pain, there was no inflammatory immune response. This suggests that neutrophils play an active role in resolving pain and protecting patients from transitioning to chronic pain.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” said Mogil.

The study findings, published in Science Translational Medicine, were replicated in a cohort of patients with temporomandibular disorder (TMD), a painful inflammation of the jaw.

Researchers also tested their theory on laboratory animals, giving mice with acute pain the anti-inflammatory steroid dexamethasone or the NSAID diclofenac. While the drugs were initially effective, researchers found that blocking neutrophils in mice ultimately prolonged their pain up to ten times the normal duration. Three other analgesics without anti-inflammatory properties (gabapentin, morphine and lidocaine) produced short-term pain relief without affecting the overall duration of pain in mice.

These findings were also supported by a separate analysis of health records for 500,000 people in the United Kingdom with acute LBP. Those that took NSAIDs were nearly twice as likely to still have pain 2 to 6 years later than those who did not take NSAIDs. Patients who took acetaminophen (paracetamol) or antidepressants – neither of which are anti-inflammatory --  were not at higher risk of transitioning to chronic LBP.

“Our findings suggest it may be time to reconsider the way we treat acute pain. Luckily pain can be killed in other ways that don’t involve interfering with inflammation,” said co-author Massimo Allegri, MD, Head of Pain Service at Policlinico of Monza Hospital in Italy and Ensemble Hospitalier de la Cote in Switzerland.

Researchers say their findings should be followed up with larger clinical trials directly comparing the long-term effects of anti-inflammatory drugs to other pain relievers that don’t disrupt inflammation.

“Together, our results suggest that active immune processes confer adaptation at the acute pain stage, and impairment of such inflammatory responses in subjects with acute LBP (or TMD) increases the risk of developing chronic pain. These adaptive inflammatory responses are intrinsically transcriptionally driven, probably modified by both genetics and environmental factors, and can be inhibited by steroids and NSAIDs,” researchers said.

“Our conclusions may have a substantial impact on medical treatment of the most common presenting complaints to health care professionals. Specifically, our data suggest that the long-term effects of anti-inflammatory drugs should be further investigated in the treatment of acute LBP and likely other pain conditions.”

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are in so many different pain relieving products, including over-the-counter cold and flu medications, that many consumers may not be aware how often they use NSAIDs. At high doses, studies have found that NSAIDs increase the risk of a heart attack or stroke.

The current draft revision of the CDC opioid guideline recommends that NSAIDs should be used for low back pain, painful musculoskeletal injuries, dental pain, postoperative pain, kidney stones and acute pain caused by episodic migraine.

Acetaminophen also has its risks. Long-term use has been associated with liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

Drug Addiction Is the Problem, Not Prescription Opioids

By Christine Kucera, Guest Columnist

The Centers for Disease Control and Prevention (CDC) is the leading national public health institute of the United States. The agency is responsible for protecting the public from health and safety threats. 

In my opinion, the CDC has no business writing clinical guidelines! Medical guidelines for healthcare/disease management, medication management, and clinical decision making should be developed, reviewed and approved by a diverse team of clinical subject area specialists and key stakeholders, including medical specialists, medical groups, advisory teams, advocates and patients. Not regulatory agencies!

The 2016 CDC opioid guideline, as currently written, has harmed and damaged millions of lives, and caused unspeakable suffering. In effect, the CDC sanctioned torture by failing to promptly address and correct the negative impact of its guideline on individual patient care, addiction and pain management treatment and resources.

The CDC has clearly overstepped its authority by creating a guideline meant to regulate the use of prescription opioids. Any regulatory measures which prevent patients from accessing prescription opioids as indicated for their health and well-being are unethical and should be reconsidered, if not totally withdrawn.

The CDC continues to propagate the false narrative that any patients requiring prescription opioids for any type of pain are or will become addicts. And it continues to claim — without any evidence — that if opioid prescriptions are limited in quantity, type, duration and dose, there will be a reduction in addiction, overdose and death. The facts indicate otherwise. Overdoses are at record high levels.

The True Causes of Addiction

Substance addiction exists because our government has failed to address its true causes, which include poor access to addiction treatment, unethical pain treatment, lack of quality care standards across medical institutions, and lack of legislative laws that protect patients from suffering needlessly. 

Addiction is caused by preventable and manageable health disparities, untreated and undertreated mental and physical suffering, genetic metabolic variability, lack of resources, lack of all-inclusive healthcare insurance, lack of provider managed pain care, lack of treatment centers, lack of access to appropriately prescribed medications, lack of drug monitoring systems, lack of access to mental health and pain care providers, lack of timely access to a comprehensive network of providers, and lack of individualized care. 

Maybe if the CDC actually focused on the above health and safety issues, we would have guidance on solving the real problems. The CDC has failed miserably to recognize that individual pain care is as unique as the patient who is suffering in pain. Every single person that has pain seeks relief.

Relief comes in many different forms, both healthy and unhealthy. These forms of relief may be self-directed and/or medically managed by clinical staff and providers, and includes exercise, yoga, rest, mobilization, heat/ice therapy, massage, mindfulness, acupuncture, Chinese herbal medicine, bio-feedback, diet, weight loss, surgeries, water therapy, bicycling, strength/weight training, martial arts, immunotherapy, TENS, anti-inflammatories, anti-seizure medication, muscle relaxants, antidepressants, biologicals, medical/recreational cannabis, CBD, kratom, prescription opioids, illicit/illegal drugs and alcohol — to name a few. 

Every Patient is Different

The journey each patient in pain takes is individual. The pain you've experienced and lived with is different from mine and everyone else’s.  

The terms “acute pain” and “chronic pain” are also misleading and are part of the false narrative. Pain is a symptom. Its management depends on its physical and/or mental cause, not how long it lasts. Pain is the body's way of sending up a red flag that something is not right.

Duration means nothing in the world of pain, as every minute of the day is different in type, in location and in intensity. Pain goes through cycles, and no person experiences pain the same way.  

Until the individuals who wrote this God awful, evil guideline experience pain that is unrelenting, agonizing, non-stop, 24/7 for their entire life, they should back off the false narrative, go back into their non-medical cave, and leave the medical decision making up to the actual physicians who are trained to manage pain with all the tools available and at any quantity required by a patient.  

What the CDC should be addressing are the sources of suffering, identifying at-risk individuals and providing a framework for implementing resources and systems of care that are fluid and adaptive to the unique circumstances of each individual.  

There are too many outstanding questions and issues which also continue to impact patients and providers. What are the FDA and DEA’s roles and responsibilities? How do their policies meet the objectives of the CDC guideline to reduce addiction, overdose and death? What impact do they have on medical providers treating patients in pain? 

Addiction is the public health issue requiring CDC input, not the utilization of prescription opioids for pain treatment. 

Christine Kucera is an intractable pain patient survivor of over 30 years. She lives with reactive psoriatic arthritis, spondylitis, polyarthritis, sacroiliitis, degenerative disc disease, dermatomyositis, mixed connective tissue disease, psoriasis, lupus, spinal radiculopathy, thoracic outlet syndrome, endometriosis stage IV, and other painful conditions.

Prior to becoming disabled, Christine was a healthcare research systems developer and analyst for federally funded CMS, AHRQ, and NIH grants and programs. 

UK Warns Pregnant Women About Taking Pregabalin

By Pat Anson, PNN Editor

Health officials in the UK are warning women of childbearing age that pregabalin (Lyrica), a drug commonly prescribed for pain, anxiety and epilepsy, raises the risk of major birth defects.

A recent study in four Nordic countries of over 2,700 pregnancies found that 5.6% of babies born to women who took pregabalin in the first three months of pregnancy had birth abnormalities. That compares to 4.1% of babies whose mothers did not use pregabalin.  

“The study showed that taking pregabalin during early pregnancy was associated with a slightly increased chance of having a baby who is born with a physical birth abnormality. It is important to note that this study could not show that pregabalin was the cause of the physical birth abnormalities,” the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a new safety alert.

The birth defects associated with pregabalin primarily involved the nervous system, eyes, face, urinary system and genitals. The MHRA – which regulates drugs in the UK – cautioned pregnant women not to stop taking pregabalin without talking to a doctor first.

“If you think you may be pregnant and are currently taking pregabalin, you should set up an appointment with your GP, specialist or nurse at your earliest opportunity, to discuss any concerns you may have. However, do continue to take pregabalin as prescribed until you can speak to them,” the MHRA alert said. “Untreated epilepsy, pain, or anxiety could be harmful to you and your unborn baby. It is important that you talk to your healthcare professional before stopping pregabalin or making any changes to your usual medicines.”

An international study in 2016 also linked pregabalin to birth defects. Women taking pregabalin were found to be six times more likely to have a baby with a major birth defect, including abnormalities in the heart, central nervous system (CNS) and other organs.

Pregabalin Concerns

In recent years, pregabalin has come under increased scrutiny in the UK.  In 2021, the MHRA said pregabalin was associated with serious breathing problems in people over age 65 and in patients with compromised respiratory systems.

Doctors in Northern Ireland were also told last year not to prescribe pregabalin for neuropathic pain due to a “significant increase” in drug-related deaths involving the drug.

In 2019, pregabalin and gabapentin (Neurontin) were both rescheduled as Class C drugs in the UK due to a rising number of overdose deaths. Health experts said the medications cause “an elevated mood in users” and could have serious side effects when combined with other drugs.

Lyrica and Neurontin are two of Pfizer’s top selling drugs and generate billions of dollars in annual sales. They belong to a class of nerve medication called gabapentinoids that were originally developed to treat seizures, but are now widely prescribed as an alternative to opioid painkillers. A 2019 study found little evidence that gabapentinoids should be used to treat pain and said their effectiveness was often exaggerated by prescribing guidelines.

In the United States, where Lyrica is approved for fibromyalgia, neuropathic pain, seizures and postherpetic neuralgia, the FDA’s lengthy warning label states that “there are no adequate and well-controlled studies with Lyrica in pregnant women,” but at the same time cautions that “Lyrica may harm your unborn baby.”  

An earlier warning label said it was “not known if Lyrica will harm your unborn baby.”

What Are the Long-Term Risks of Prescription Opioids?

By Roger Chriss, PNN Columnist

A standard critique of prescription opioids is the absence of good long-term data on safety and efficacy. Clinical trials are generally short-term and last only a few weeks, so questions about cumulative long-term risks, including addiction and overdose, remain unclear.

Clinical trials that run for a year or more are complex and costly. Attrition may be high and outcomes may be muddied by the inevitable effects of aging, disease progression, and life events. There are also ethical issues involved with subjecting patients to long-term trials where they may receive nothing more than a placebo.

In other words, launching new trials is often impractical. Fortunately, there are a few other ways to answer questions about long-term opioid risk.

Compare Outcomes

First, we can compare outcomes among patients whose key difference is opioid dosage. In a recent Canadian study, researchers looked at over 2 million individuals in Ontario given an opioid prescription between 2013 and 2016 for pain. They identified 1,121 patients who had a fatal or non-fatal overdose – a minuscule overdose rate of 0.0055 percent.

But when compared to patients getting relatively low daily doses of 20 morphine milligram equivalents (MME), those who received 200 MME or more had a “high hazard of overdose.”  

A dose of 200 MME may be an extreme example, since Canadian guidelines recommend that initial doses be limited to no more than 50 MME. But researchers said their study proves the value of guidelines. 

“Although the absolute risk of an opioid overdose within the first year of prescription opioid use is low, better alignment of opioid initiation practices with guidelines may reduce opioid-related harm,” they concluded. 

Compare Opioids 

Second, we can compare two opioids: oxycodone and hydrocodone. In a retrospective analysis of patients in Oregon between 2015 and 2017, researchers found that after an initial prescription in opioid-naive people, 0.3% experienced a fatal or non-fatal overdose and 2.8% refilled an opioid prescription at least six times, what the researchers considered “chronic opioid use.” 

Patients who received oxycodone were less likely to develop chronic use than those receiving hydrocodone, but the oxycodone patients had a slightly higher risk of overdose.  

Based on that finding, researchers concluded that “hydrocodone may be the favorable agent” when starting people on opioids. 

Compare Odds

We can also use statistical inference to estimate risks. In an analysis of 13,884 U.S. adults living with chronic pain between 1999 and 2004, epidemiologists found that 5% died from all causes within 3 years and 9% died within 5 years.  

Researchers found that chronic pain patients on opioids had a slightly higher risk of death – and calculated an odds ratio of 1.06 for them dying within three years and 1.03 at five years compared to those not taking opioids.  

It’s hard to infer much from a study like that, because researchers didn’t establish a causal relationship between opioids and death. Since chronic pain itself raises the risk of dying, the findings could simply mean that patients on opioids are sicker, in more pain, and closer to death.  

Despite this, researchers came to the sweeping conclusion that “chronic pain increased the risk of all-cause mortality through opioid prescriptions.” 

Compare Health Outcomes 

Last, we can look at health outcomes. An alarming, preliminary study from Taiwan evaluated chronic pain patients on long-term opioid therapy and found they have significantly higher risk for cancer compared to those not taking opioids. 

The overall hazard ratio for the opioid group was 2.66 – which means they have over twice the risk of having many different types of cancer. 

“Long-term opioid use might be a significant risk factor for breast, gastric, colorectal, ovarian, prostate, lung, pancreatic, head and neck, and esophageal cancers and HCC (hepatocellular carcinoma),” researchers concluded in their study, which has not yet been peer-reviewed. 

Risks of Other Drugs 

These findings help shed light on the long-term risks of prescription opioids, at least compared to healthy control subjects who do not take opioids. However, that is not the situation faced by most people with chronic illness, who are often on multiple medications to manage their pain and other symptoms.  

As a result, we need to know the risks of non-opioid pain management options. For instance, the consequences of cannabis addiction are low compared to opioids. But the cancer risk appears to be substantially higher. A major review in BMC Archives of Public Health found that “cannabinoids including THC and cannabidiol are important community carcinogens exceeding the effects of tobacco or alcohol.”

The risks of non-steroidal anti-inflammatory drugs (NSAIDs) are well-known. According to a 2011 review, “chronic NSAID use increases the risk of peptic ulcer disease, acute renal failure, and stroke/myocardial infarction. Moreover, chronic NSAID use can exacerbate a number of chronic diseases including heart failure and hypertension.” 

For other non-opioid medications, we lack long-term studies. For instance, a 2017 Cochrane review on gabapentin for chronic neuropathic pain notes that “study duration was typically four to 12 weeks.” Cochrane also notes that only short-term trials were conducted for serotonin and norepinephrine reuptake inhibitors like duloxetine for fibromyalgia.  

As for non-pharmacological options like spinal cord stimulators, the situation is similarly uncertain. A new Australian study in the Journal of Patient Safety found that for every 10 stimulators that were surgically implanted, four had to me removed for various reasons. That outcome went unnoticed in short-term studies and emphasizes the need for more careful patient selection and monitoring of outcomes.  

There are real risks to prescription opioids but it would be simplistic to dismiss them entirely. As pain physician Antje Barreveld notes in a recent STAT News op-ed: “Opioids do have a place in pain control and can be safely prescribed, even at high doses, by following best practices while monitoring for risks and side effects.” 

Understanding the long-term risks of prescription opioids will be important as the CDC finalizes its revised opioid guideline, and as regulators, insurers and clinicians decide how to act on them. But more generally, we need long-term studies of all pain management modalities so that we can better understand their risks.

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. 

Prescription Opioid Use Fell Nearly 7% in 2021

By Pat Anson, PNN Editor

Prescription opioid use in the United States fell by 6.9% in 2021, the tenth consecutive year the volume of opioid pain medication has declined, according to a new report by the IQVIA Institute, a healthcare data tracking firm.

The decline in opioid consumption came even as prescription drug use overall reached record levels in 2021, fueled in part by new COVID-19 vaccines and therapeutics. Spending on medicines rose 12% to $407 billion last year, according to IQVIA, with 194 billion doses of medication dispensed.

While longer opioid prescriptions were written in the early stages of the pandemic to accommodate patients who didn’t see their doctors as often, prescribing quickly returned to its decade-long downward trend.

“Prescription opioid use has fallen by 48% over the past five years and is now at levels last seen in 2000, reflecting efforts by many stakeholders to limit and manage appropriate prescription opioid use,” IQVIA said in its annual report on medicines in the U.S.      

IQVIA tracks opioid prescriptions in morphine milligram equivalents (MMEs). The company estimates that per capita opioid use fell to 309 MME last year (about 0.84 MME per day), down from a peak of nearly 800 MME in 2011.

Some providers have reduced their opioid prescribing more than others. Since 2016, surgeons, anesthesiologists, dentists and general practitioners have cut their opioid prescribing by over 50 percent, while nurse practitioners and physician assistants have reduced their prescribing by 27 percent.

Prescription Opioid Use and by Prescriber Specialty

Opioid consumption by Americans has fallen so sharply in recent years that Canada, Australia and several European countries have overtaken the U.S. and become the highest consumers of opioid medication. A recent study ranks the U.S. as 8th globally in per capita opioid sales.

The decline in U.S. opioid prescribing has failed to stop the surge in overdoses. The CDC estimates that 106,854 people died from drug overdoses in the 12-month period ending November 2021, with drug deaths more than doubling in the last six years. Synthetic opioids – primarily illicit fentanyl – were involved in about two-thirds of fatal overdoses in the past year.

Patients Blamed for Diversion 

Despite the historic decline in prescription opioid use, some politicians continue to blame opioid medication, prescribers and even patients for the nation’s overdose epidemic.

In comments recently submitted to the CDC on its revised opioid guideline, West Virginia Attorney General Patrick Morrisey and 10 other state attorneys general said the agency needs to do more to prevent the diversion of prescription opioids.

“Diversion must remain a key consideration of any prescribing guideline,” said Morrisey.

“Although drug dealers and unethical physicians are responsible for much of the opioid diversion nationwide, legitimate prescriptions remain a prime source of diversion, too. Diverted opioids most commonly reach drug abusers through friends and family members who filled a legitimate prescription.

“The amount of opioids prescribed in recent years has been excessive and far beyond the amount necessary to support legitimate medical need.”

— Patrick Morrisey, West Virginia Attorney General

“Indeed, the amount of opioids prescribed in recent years has been excessive and far beyond the amount necessary to support legitimate medical need. And over-prescription allows legitimate prescriptions to fall into the hands of patients’ family and friends.”

How common is it for prescription opioids to be diverted? Not common at all, according to the DEA’s National Drug Threat Assessment, an annual report that estimates less than 1% of legally prescribed opioids are diverted.  “The number of opioid dosage units available on the retail market and opioid thefts and losses reached their lowest levels in nine years,” the DEA’s 2020 report found.

Despite this, Morrisey puts the onus on pain patients to prove that they’re not abusing or selling their prescriptions. He and the other attorneys general called for routine drug testing of pain patients – rejecting evidence that fraud is common is the drug testing industry and that widely used point-of-care urine tests often give false results that lead to patient abandonment.

“The given reasons that toxicology screenings might lead to ‘stigmatization,’ encourage ‘inappropriate termination from care,’ or be ‘misinterpreted’ are unsatisfactory,” Morrisey wrote. “First, what stigma would the patient face? Diagnostic results are private information. The only people who would know that the test is performed are the patient and the prescriber. The prescriber is already familiar with the patient’s prescriptions, so this process would not reveal any new information -- unless, of course, the patient had lied or not followed the prescriber’s directions.”

Remarkably, the 7-page letter from Morrisey never acknowledges that most drug deaths involve street drugs, not prescription opioids, and makes no mention of fentanyl. The most recent overdose data from West Virginia – Morrisey’s home state – indicates nearly 3 out of 4 drug deaths involve fentanyl.    

Morrisey’s letter was co-signed by the attorneys general of Arkansas, Indiana, Kansas, Mississippi,
Nebraska, South Carolina, South Dakota, Utah, Kentucky and Virginia.

FDA Warns Supplements for Pain Contain Undeclared Drugs

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning consumers not to purchase or use dietary supplements marketed for pain relief under the brand names “Artri King” or “Ortiga” due to potentially dangerous ingredients not listed on their labels. Use of the products has led to at least one death, according to the FDA.

The Artri King and Ortiga supplements are promoted as treatments for arthritis, muscle aches, osteoporosis, bone cancer and other painful conditions – and list ingredients such as glucosamine, turmeric and Omega 3. But FDA laboratory analyses found the supplements also contain undeclared drugs such as steroids, muscle relaxants and non-steroidal anti-inflammatory drugs (NSAIDs):

• Dexamethasone (a corticosteroid) is commonly used to treat inflammatory conditions. It can impair a person’s ability to fight an infection and at high doses can cause increased blood glucose levels, changes in blood pressure, damage to bones, psychiatric problems and adrenal dysfunction.

• Diclofenac sodium (a NSAID) can raise the risk of cardiovascular problems, such as heart attack and stroke; serious gastrointestinal damage, including bleeding, ulcers, and fatal tears of the stomach and intestines; and liver toxicity that can result in death or the need for a liver transplant.

• Methocarbamol (a muscle relaxant) can cause sedation, dizziness and low blood pressure.

Artri King advertisement

The FDA urges consumers taking the supplements to immediately talk to a healthcare provider about safely discontinuing their use because suddenly stopping the undeclared drugs may be dangerous. The drugs may also interact with other medications a person is taking.

The FDA said it has received reports of adverse events, including liver toxicity and death, associated with the use of Artri Ajo King supplements since the agency issued its first warning on January 5, 2022. A second warning about Artri King was issued this week.

The FDA’s new warnings include Ortiga Mas Ajo Rey and Ortiga Mas Ajo Rey Extra Forte supplements, which are promoted as treatments for joint pain and arthritis.

Artri King and Ortiga sold their products on various websites, including Amazon, Walmart and E-Bay, as well as some retail stores, primarily targeting Spanish-speaking consumers.

Acetaminophen Warning Labels Ineffective

Sometimes warnings from government health agencies don’t have their intended impact. Such is the case for warnings from Health Canada about taking high doses of acetaminophen, a pain reliever widely used in over-the-counter medicines for headache, cough, cold and flu.

Product labels for acetaminophen were changed in Canada in 2009 to warn of the risk of possible liver damage. In 2016, the labeling was updated with additional information about safe dosing and to identify products containing acetaminophen.

But those changes did not decrease rates of hospitalization for acetaminophen overdoses, according to a new study published in CMAJ (Canadian Medical Association Journal).  In an analysis of more than 12 000 hospital admissions for acetaminophen overdoses in Canada between 2004 and 2020, researchers found the updated warning labels had little impact.

"We found that changes to acetaminophen labels that communicated the risks of overdose and the presence of acetaminophen in over-the-counter products did not affect rates of hospital admission for accidental acetaminophen overdose, ICU admission for accidental acetaminophen overdose and admission for acetaminophen overdoses involving opioids," writes lead author Dr. Tony Antoniou, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto.

Previous research has found that less than half of patients regularly read labels for over-the counter analgesics, and only 26% read the active ingredients before using them the first time. Acetaminophen is used in so many different products that consumers may be unaware how much they’re taking. As a result, up to 6% of patients exceed the maximum daily recommended dose.

The FDA warned U.S. consumers about the risk of acetaminophen causing liver injury in 2009. Five years later, the agency told manufacturers to stop selling drug products with more than 325 milligrams of acetaminophen per dose.

Those actions have done little to prevent adverse reactions to acetaminophen. According to the FDA’s Adverse Events Reporting System, nearly 2,800 adverse events involving acetaminophen were reported in 2009. By 2021, the number of adverse events had grown to over 15,000, a 440% increase. Over 27,000 drug deaths involving acetaminophen were reported from 2009 to 2021.

Cannabis Legalization Reduced Rx Drug Use for Several Conditions, Not Just Pain

By Pat Anson, PNN Editor

Cannabis products are often touted for their pain relieving properties and some studies have shown that medical marijuana can even help patients reduce their use of opioids.

But a large new study by researchers at Cornell University found that legalization of recreational marijuana significantly reduced demand for a broad range of prescription drugs used to treat depression, anxiety, seizures and other health conditions.

The study, published in the journal Health Economics, looked at prescription data for Medicaid patients in all 50 states from 2011 to 2019, focusing on 11 states where the recreational use of cannabis was legalized: Arizona, Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington.

Researchers found significant reductions in Medicaid prescribing rates for pain and five other condition-specific drug classes after the first year of legalization:

• -12.2% Anxiety

• -11.1% Depression

• -10.8% Sleep  

• -10.7% Psychosis

•  -9.5% Seizures

•    -8% Pain

Prescribing rates for the six conditions declined even more in the second and third years after recreational cannabis was legalized.

"These results have important implications," wrote lead author Shyam Raman, a doctoral student in the Cornell Jeb E. Brooks School of Public Policy. "The reductions in drug utilization that we find could lead to significant cost savings for state Medicaid programs. The results also indicate a potential harm reduction opportunity, as pharmaceutical drugs often come with dangerous side effects or – as with opioids – potential for misuse.”

Raman and his colleagues did not see a measurable change in the prescribing of drugs used to treat nausea, spasticity or glaucoma. They also note that their study did not look at the health of patients who stopped or reduced their use of prescription drugs, or at the long-term effects of substituting cannabis for pharmaceuticals.

A small study at Harvard Medical School recently found that chronic pain patients reported significant improvements in their pain, sleep, mood, anxiety and quality of life after six months of cannabis therapy.

Recreational cannabis is now legal in 18 states and Washington, DC, while medical marijuana is legal in 37 states and Washington, DC. Cannabis has become so popular — and accessible — that a recent Harris poll found that twice as many Americans are using cannabis or cannabidiol (CBD) to manage their pain than opioids.

While the findings are intriguing, the small number of patients involved in most cannabis studies makes it hard to draw firm conclusions. In 2021, two professional pain societies – the International Association for the Study of Pain (IASP) and the Australian and New Zealand College of Anaesthetists -- released policy statements saying they could not endorse the use of cannabis for pain because there are no large, high-quality clinical trials of cannabis as an analgesic.

Mistrust Shadows CDC Over New Opioid Dose Guidance

By Pat Anson, PNN Editor

Pain patients and healthcare providers are giving mixed reviews to proposed changes to the CDC opioid guideline, according to a large new survey that found many are skeptical the revisions will make doctors more willing to prescribe opioids. Others fear the revised draft could lead to even lower and ineffective doses of opioids being prescribed.

Over 2,500 patients, providers and caregivers responded to PNN’s survey on the revised opioid guideline, which is intended to undo some of the damage caused by the agency’s 2016 guideline.

States, insurers, regulators and law enforcement made many of the original guideline’s voluntary recommendations mandatory, resulting in millions of patients being abruptly tapered or taken off opioids. Fearing scrutiny or even prosecution for “overprescribing” opioids, some doctors stopped treating pain altogether.

Like the original guideline, the revised draft still discourages the use of opioids, but clearly states the CDC’s recommendations are intended “to support, not supplant, clinical judgment” and “should not be applied as inflexible standards of care.”

When asked if the revised 211-page guideline is an improvement over the original, only four out of ten people (39%) said it was “improved” or “much improved.”  Most respondents said it was about the same or even worse.

“It is very long and involved but seems like a bait and switch. Starts out speaking to the damage done by 2016 guideline. Then seems to restrict needed medication even more,” a patient told us. 

“Both the original and the revised guidelines are fraught with politics. Nothing's changed. The guidelines are still as harmful as they were when they were published in 2016. No appreciable improvements have been made,” said another. 

IS THE REVISED GUIDELINE AN IMPROVEMENT OVER 2016 GUIDELINE?

“It looks like a step in the right direction, but I'm not sure. I don't think the CDC should be interfering between doctors and their patients,” another patient said.  “My current doctor had his practice raided in a Gestapo-like action that found zero violations. CDC and DEA need to back off and let doctors treat their patients.”

50 MME Perceived As New Hard Limit

The 2016 guideline strongly encouraged doctors not to write prescriptions that exceed doses of 90 morphine milligram equivalents (MME) per day. That 90 MME limit has been dropped from the revised draft, but doctors are still urged to be cautious about going over 50 MME because higher doses have “diminishing returns in benefits relative to risks.”

The language about 50 MME is essentially unchanged from the 2016 guideline, but many patients and providers are worried about it. Over 97% of survey respondents said they are “somewhat concerned” or “very concerned” that 50 MME will be seen as the new hard limit for doses, a level many consider inadequate for pain relief.

“The CDC is assuming that, by reducing the misapplied 90 MME standard to 50 MME, it will reduce misapplication of the standard. Faulty logic. It will, in fact, make it even harder for pain patients to be prescribed more than 50 MME, and the result will be more people in more pain and an increase in pain patient suicides,” one patient told us.

“There should be NO MME! It is too specific to use for everyone. We shouldn't be treated all the same. Each person's pain is different. It was bad enough when it was 90, to now reduce it to 50 MME is just awful,” another patient wrote.  

“50 MME will be the new 90 MME. That’s the crux of it, despite the flowery fenestration and hollow words that 2016 gave the wrong impression. They are merely patronizing us, while lowering the guidelines for how much doctors will actually prescribe,” said another.

ARE YOU CONCERNED 50 MME WILL BE SEEN AS THE NEW HARD LIMIT FOR OPIOIDS?

“There should be no specific numbers concerning daily dosages. This should be between a patient and their doctor. All of the state laws that control opioid medications need to be overturned and the CDC needs to stop attempting to practice medicine,” a patient said.

‘Leave Pain Management to the Experts’

People are also skeptical that the revisions will ease doctors’ concerns about prescribing opioids. Nearly two-thirds (61%) said the changes won’t make doctors more willing to prescribe the drugs. 

“I'm glad they are changing, but I think the damage has already been done. My doctor took me off pain meds completely and life has been a living hell! Now that he's done that, I don't think he will be open to prescribing them again no matter how many chronic pain issues I have!” said a patient. 

“My doctors took me off pain meds because they were afraid of losing their license and they still are. I sent (them) the link to the new guidelines and they still will not do anything for my pain,” another patient said. “One doctor said, ‘If we give pain meds to our patients who need it, CDC will still be after us for giving pain meds so we can’t take that chance.’” 

DO YOU THINK REVISIONS WILL MAKE DOCTORS MORE WILLING TO PRESCRIBE OPIOIDS?

“I think the CDC needs to keep his nose out of providers business. I’ve been practicing pain management for 22 years,” a doctor told us. “The CDC guidelines of 2016 have ruined untold lives because they stuck their nose somewhere they shouldn’t have. Leave pain management to the experts and let them decide what each patient needs based on their individual condition.” 

Guideline Expansion

Patients and providers are a bit more receptive about the guideline being expanded to include recommendations for treating short-term acute pain (55%), as well as a handful of specific pain conditions, such as low back pain and migraine (53%).  

Patients with severe constant pain — known an intractable pain — feel left out of the guideline. The word “intractable” is not even mentioned in the draft revision. While some types of severe pain, like cancer pain and sickle cell pain, are specifically excluded from the guideline, others are not.

“I wish that consideration would be given for patients who have intractable pain and have already jumped through the hoops of therapy and other treatments and have found that they didn’t help. It is beyond discouraging to have to repeat trials of treatments that never work for that particular patient,” said one patient.

“There is no difference in cancer and non-cancer pain. Pain is pain. If they’re going to include any conditions (which I don’t think they should) they should recognize rare and incurable illnesses, not just low back pain, sickle cell, and cancer,” another patient wrote. 

End Mandatory Policies

Large majorities also think the CDC needs to do a better job tracking the impact of its guideline on patients (95%) and making sure it is not used to create mandatory policies (96%).

The American Medical Association has even recommended that the CDC undertake a “a national marketing and communications campaign” to make clear to law enforcement and healthcare providers that the revised guideline should not be used like its predecessor to adopt rules that replace individualized patient care. 

Many of our survey respondents agree. Without the elimination of laws and policies that dictate how pain should be treated, no amount of revisions to the guideline will not undo the damage the CDC’s recommendations have already caused. 

“It should be made clear to the doctors willing, but currently afraid, to prescribe opioids now for fear of fines, loss of income and even jail, that they won't be penalized for properly caring for their patients,” said one patient. “These doctors feel their livelihood has been threatened just for doing their job, which is to help people in pain. They are no longer doing that.” 

For more survey findings, including whether respondents think the CDC guideline should be revised or revoked, click here. You can see the full survey results here.

The CDC recently close a public comment period on the guideline revisions. Over 5,400 comments have been received and publicly posted, which you can read here. The CDC is not expected to adopt the final version of its revised guideline until late this year.  

Too Little, Too Late: Patients and Providers Say Changes to CDC Opioid Guideline Inadequate

By Pat Anson, PNN Editor

Proposed changes to the CDC’s opioid prescribing guideline are inadequate and will not undo the damage caused to patients and the practice of pain management, according to a large new survey by Pain News Network.

The Centers for Disease Control and Prevention released a long-awaited draft revision of its 2016 guideline in February, giving healthcare providers more flexibility in how they manage pain with opioids. Although voluntary, the original guideline was widely misapplied as a rigid “standard of care” by many states, insurers, doctors and law enforcement, causing millions of patients to be taken off opioids or tapered to lower doses.

The revised guideline states that “opioids can be essential medications for the management of pain” and encourages doctors to use their own best judgement when prescribing them. But many patients and providers believe the changes don’t go far enough and may even make the crisis in pain care worse.

“Appreciate the effort, but too little too late. These revisions are like trying to prevent disaster by course correcting the Titanic after it hit the iceberg,” one patient told us. “The revisions offer no protection against overzealous DEA interference and prosecution, and are meaningless in court. Until the draconian laws spawned by the guidelines are changed, things will only continue to get worse.”

“I believe it is a small step in the right direction, though the damage has already been done. The doctors who truly care about their patients and would like to help them are still terrified of the potential repercussions from the governing bodies,” another patient said.

“In 45 years of treating patients with pain, I have never seen it so difficult for patients to have their reports of pain taken seriously and get access to pain treatment,” a doctor said. “Patients often feel treated like addicts, and have had many professionals and family members supporting that erroneous and stigmatizing label.”

‘I Barely Leave the House’

Over 2,500 patients, providers and caregivers in the U.S. responded to PNN’s survey, the vast majority (94%) identifying themselves as patients with either chronic or short-term acute pain.

Over half the patients (57%) rated the quality of their pain care as poor or very poor. Only one in five (20%) rated it good or very good.

This was the fifth survey we’ve conducted on the CDC guideline. Like the others, people expressed strong opinions about the agency’s recommendations and how they’ve impacted pain care.

“My pain medication was involuntarily reduced by 75% since the the last guideline was published,” a patient told us. “Now I barely leave the house. I can't do my physical therapy due to excessive pain.”

HOW WOULD YOU RATE THE CURRENT QUALITY OF YOUR PAIN CARE?

“The 2016 guidelines caused me to have to go on disability, spend 20 hours a day in bed due to severe back pain, and sell a bank consulting company that I had run successfully for 20 years. The CDC needs to get out of pain medicine,” another patient said.

Should CDC Have Opioid Guideline?

When asked if the CDC should even have guidelines for pain management and opioid prescribing, eight out of ten respondents (84%) said no. Many said the agency overstepped its authority.

“It is outside the CDC's charter and purpose to publish opioid guidelines. If an opioid guideline is needed, that would be the FDA's responsibility. Why is our government even allowing the CDC to do this? They are expending resources on something that is unnecessary and outside of their area of responsibility,” a patient wrote.

“The "D" in "CDC' is for "disease." Pain is not a disease. CDC should stick to its mission,” said another patient. 

“The CDC should not be allowed to regulate pain medications. The CDC conveniently made a disease to justify getting involved in an area that was not their area to regulate. The guidelines were biased against chronic pain. The (guideline) panel was biased by people with preconceived ideas,” a provider wrote. 

‘Made Each Day a Living Hell’

Asked if the 2016 opioid guideline improved the quality of pain care or made it worse, nearly nine out of ten respondents (88%) said pain care in the U.S. was significantly worse. Only 2% believe the guideline improved pain care. 

“I had a friend that was seeing a pain management physician, and he was on high dose opiates for 10 years due to a car accident, and because of the 2016 guidelines, his doctor became very fearful and took him off his meds,” a patient told us. “That person committed suicide.”

“CDC regulations may have saved the lives of some addiction-prone people, but it's made each day a living hell for millions of us with progressive chronic pain,” another patient said.

“The damage has been done. Patients are still dead, physicians are still terrified, and these deaths and loss of practice were totally unnecessary. It is a disgusting example of ill-informed government over reach,” said another.

DID 2016 GUIDELINE IMPROVE PAIN CARE OR MAKE IT WORSE?

‘Pain Drove Me to Street Drugs’

Perhaps the most damning assessment of the 2016 guideline is that it made the opioid crisis worse – an opinion shared by nearly eight out of ten survey respondents (78%). When denied access to opioids, some patients have turned to street drugs.

“Chronic pain drove me to use street drugs, including fentanyl, when all I needed was a doctor to prescribe a safe medicine for me,” a patient told us. “It's messed up I have to do this for relief.”

“Patients know about their pain, doctors know their patients, the CDC does not know individual patients. Making it harder to get much needed medications is what causes people to try and obtain opioids illegally,” said a patient.

“People in chronic pain who cannot get relief from doctors are turning to street drugs - and THEN getting hooked. The CDC is CAUSING drug addiction,” wrote another patient.

“The people who benefit from the CDC guidelines are lawyers, politicians and drug dealers. The drug dealers can sit back and rake in the money while the CDC, lawyers and politicians do their work for them.”

DO YOU THINK THE 2016 GUIDELINE MADE THE OPIOID CRISIS WORSE?

 ‘Revoke the Guidelines’

What should be done with the 2016 guideline? Should it be revised? Can it be fixed? Nearly two-thirds of respondents (63%) believe it should be completely revoked or withdrawn. About 36% believe changes are needed to make opioid medication more accessible.

“The CDC needs to completely revoke the 2016 guidelines and let trained professionals treat their patients for pain. Unfortunately, some of the damage that was done is irreversible and some patients have lost their lives as a consequence, and that lies squarely on the shoulders and consciousnesses of the CDC,” a provider told us.

“DESTROY IT NOW! No updates are needed,” a patient wrote. “Just get rid of these guidelines completely and get out of the middle, coming between a doctor and his pain patient, as well as the patient and their pharmacy.”

“Revoke the guidelines and revoke the CDC’s ability to have anything to do with medications, leave that to the FDA and doctors. Also revoke the DEA’s ability to prosecute and/or harass doctors and make them focus on drug dealers and cartels,” another patient wrote.

WHAT SHOULD BE DONE WITH 2016 GUIDELINE?

‘CDC Has Lost All Credibility’

Given all the problems created by the 2016 guideline and the lengthy delay in revising it, many people have lost faith in the CDC — once one of the most trusted government agencies in the U.S. Asked if the CDC could be trusted to handle the revision of the opioid guideline in an unbiased and scientific manner, nearly 96% said no.

“I do not and will never trust them. This revision is nothing more than putting lipstick on a pig,” a patient said.

“The CDC has lost all credibility with me. They lie, falsify records to suit their argument, pick and choose things in studies to support their argument, and they have anti-opioid zealots writing these guidelines. Clear conflict of interest! CDC and DEA need to get the hell out of my doctor-patient relationship!” said another patient.

“The CDC were warned their Guidelines would harm patients, and they moved forward anyway. They refused to monitor harm to patients or acknowledge it. The CDC's unethical behavior continues over and over at shocking levels. They have broken the public trust over and over. Nothing they've written can be trusted after these deliberate and intentional unethical choices,” a patient wrote.

For more survey findings, including what respondents think about the CDC’s new guidance about doses, click here. You can see the full survey results here.

Overdose Deaths Double for Teenagers Amid Fentanyl Surge

By Pat Anson, PNN Editor

Drug deaths among U.S. teenagers have risen sharply in the last two years, according to a new study that found the number of fatal overdoses doubled for adolescents aged 14 to 18 years.

In 2019, there were 492 drug deaths among adolescents. In 2021, there were an estimated 1,146 fatal overdoses, a 133% increase.

The vast majority of adolescent drug deaths last year involved illicit fentanyl (77%), followed by benzodiazepines (13%), methamphetamines (10%) and cocaine (7%). Less than 6% of the overdoses among teens involved a prescription opioid.

The study findings, reported in the journal JAMA, reflect what is happening in the overall U.S. population, with drug overdoses rising to record levels. They also mark the reversal of a decade long trend of fewer overdose deaths among teens, which coincided with declining rates of illicit drug use.

Researchers say adolescents may be unaware or naive about the risks posed by fentanyl, a synthetic opioid up to 100 times more potent than morphine and 50 times stronger than heroin. In a prescription, fentanyl plays a valuable role in treating severe pain, but as a street drug it can be deadly

“Beginning in 2020, adolescents experienced a greater relative increase in overdose mortality than the overall population, attributable in large part to fatalities involving fentanyls,” lead author Joseph Friedman, MPH, University of California, Los Angeles, reported in the journal JAMA.

“In the context of decreasing adolescent drug use rates nationally, these shifts suggest heightened risk from illicit fentanyls, which have variable and high potency. Since 2015, fentanyls have been increasingly added to counterfeit pills resembling prescription opioids, benzodiazepines, and other drugs, which adolescents may not identify as dangerous and which may be playing a key role in these shifts.”

U.S. Adolescent Overdose Deaths

SOURCE: jama

Friedman and his colleagues found the highest overdose rates among Native American, Alaska Native and Latino adolescents, reflecting what they called a “wider pattern of increasing racial and ethnic inequalities” in drug deaths.

Fentanyl is even killing kids who have not reached their teenage years. In California, a boy was recently arrested and charged with murder in the death of 12-year-old Dalilah Guerrero. The 16-year-old suspect allegedly sold a counterfeit pill made with fentanyl to the girl, who overdosed after crushing and snorting the tablet at a party in San Jose.

The spike in adolescent drug deaths comes even as substance abuse by teens fell to record lows. An annual survey by the University of Michigan found significant declines in all types of drug use by adolescents in 2021, with the use of prescription opioids falling to the lowest level in nearly two decades.    

DEA Warns of Fentanyl Mass Overdoses

Public health experts and law enforcement agencies are growing increasingly alarmed by the rising number of fentanyl overdoses. Last week, the DEA warned of a nationwide spike in fentanyl-related mass overdose events, in which three or more overdoses occur in the same location.

In the past three months, at least seven mass overdoses were reported in Florida, Texas, Colorado, Nebraska, Missouri and Washington, DC, resulting in 29 deaths. Three people died in a hotel room in Cortez, Colorado after ingesting what that they thought were 30mg oxycodone pills, but were actually counterfeit pills containing fentanyl.

“Tragic events like these are being driven by fentanyl. Fentanyl is highly-addictive, found in all 50 states, and drug traffickers are increasingly mixing it with other types of drugs — in powder and pill form — in an effort to drive addiction and attract repeat buyers,” DEA Administrator Anne Milgram said in a letter to federal, state and local law enforcement agencies. 

“We recommend that the members of your offices assume that all drugs encountered during enforcement activities now contain fentanyl. Given fentanyl’s extreme toxicity and the increases we are seeing in the distribution of polydrug substances containing fentanyl, please take all the precautions you would take when handling fentanyl whenever you interdict any illicit substance.”

A recent study by the National Institute of Drug Abuse estimated that over 9.6 million counterfeit pills containing fentanyl were seized by U.S. law enforcement agencies last year.