Prenatal Use of Acetaminophen Linked to Early Puberty

By Pat Anson, PNN Editor

The daughters of women who took acetaminophen during pregnancy tend to start puberty early, according to a new study by Danish researchers.  

The study is the latest indication that prenatal use of acetaminophen – more commonly known as paracetamol outside the U.S. -- can have long term effects on children.

Researchers at Aarhus University studied health data on about 100,000 Danish women who provided detailed information about their use of acetaminophen during pregnancy.

Nearly 16,000 children born to those mothers between 2000 and 2003 were followed from the age of eleven and throughout puberty, with surveys every six months about different aspects of their development.

The study, published in the American Journal of Epidemiology, found that girls on average entered puberty between one-and-a-half and three months earlier if their mothers took the over-the-counter pain reliever for more than 12 weeks during pregnancy.

"We found a 'dose-response' correlation. That is to say, the more weeks with paracetamol during pregnancy, the earlier puberty in girls, but not in boys," says lead author Andreas Ernst, a PhD student from the Department of Public Health at Aarhus University.

"While entering puberty one-and-a-half to three months earlier may seem unimportant, when taken together with the frequent use of paracetamol during pregnancy, our findings ought to make people take notice. Our results are certainly not the decisive factor that should change current practice, but the perception of paracetamol as 'the safe and harmless choice' during pregnancy ought to be challenged."

Early puberty development increases the risk of serious diseases in adulthood, such as obesity, diabetes, cardiovascular diseases and testicular and breast cancer.

The use of acetaminophen (paracetamol) has been increasing worldwide and studies have found that over half of pregnant women in the U.S. and European Union use the pain reliever at least once during their pregnancy. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications.

Previous research has shown that prenatal use of acetaminophen is associated with slow language development, autism and attention deficit problems in young children.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. The FDA label for products containing acetaminophen warns about the risk of liver damage and other side effects but does not specifically warn pregnant women about using the pain reliever. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

In its 2016 opioid prescribing guidelines, the CDC recommends acetaminophen as an alternative to opioid pain medication. The guideline only briefly mentions that acetaminophen is involved in hundreds of overdose deaths annually and can cause liver problems.

The CDC guideline does warn pregnant women -- at length -- that opioids can cause birth defects, poor fetal growth, still births and neonatal opioid withdrawal syndrome.

Patients at Ohio Hospital Have Surgery Without Opioids

By Pat Anson, PNN Editor

Would you want to go through a major surgery without the use of opioid pain medication?

Patients at an Ohio hospital are getting acetaminophen, gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs) to manage their pain before and after colorectal operations – and their surgeons say the treatment results in better patient outcomes.

“Over 75 percent of our elective colorectal patients underwent surgery without requiring narcotic analgesics postoperatively, including after discharge,” says Sophia Horattas, MD, of Cleveland Clinic Akron General Hospital.  “During this time period our patient satisfaction scores improved as well as patients' perceptions of pain control.”

All eight general surgeons at Akron General adopted the non-opioid treatment protocol in 2016, applying it to patients who had elective colon operations. Prior to surgery, the patients were all educated about pain management, non-opioid analgesics, and the risks associated with opioids.

Researchers evaluated 155 of the patients and presented their findings this week at the American College of Surgeons Clinical Congress in Boston.

Overall, 83 percent (128) of the patients did not need opioid medication after their operations. Among those who did, use of opioids before surgery was often an indicator that they would want them again. Nine of the 15 patients who had prior experience with opioids used them again after surgery.

Among the remaining 140 patients who did not use opioids before surgery, 85 percent (119) did not need opioid medication for pain relief.

The researchers found that patients who used opioid painkillers typically spent more time in the hospital; an average of 2.7 days vs. 2.3 days for the non-narcotic group.

“Patient education played a large role in protocol compliance, and patient satisfaction improved as they were able to avoid prolonged fasting, achieve improved pain control without the side effects of narcotic analgesia, and be discharged home earlier,” said Horrattas.

For pre-emptive analgesia before surgery, patients received one dose of acetaminophen, gabapentin, and the NSAID celecoxib (Celebrex).  In the operating room, patients received a nerve block and underwent anesthesia with the non-opioid pain relievers ketamine and lidocaine.   

Surgeons at Akron General have since adopted the non-opioid protocol for other major abdominal operations, such as bariatric procedures, gynecological and genital/urinary tract procedures, and liver and gall bladder operations.

“One of the great things about our protocol is its reproducibility.  Once we developed our program, we found that it could be standardized across departments with consistently reproducible results,” said Horattas.

Akron General’s protocol is similar to guidelines adopted by the American Pain Society (APS) for postoperative pain care. The APS also encourages the use of non-opioid medications such as acetaminophen, NSAIDs, gabapentin (Neurotin) and pregabalin (Lyrica).  

Akron General gets below average ratings for patient satisifaction from Hospital Compare, a Medicare survey that asks patients about their experiences during a recent hospital stay. The hospital received only two of a possible five stars, which places it in the bottom third of hospitals nationwide. Only 68% of Akron General’s patients said they would definitely recommend the hospital.

According to Healthgrades, 3 percent of the patients died after a colorectal surgery at Akron General, which is slightly below the national average for that procedure.

Opioid Addiction Rare After Surgery

In recent years, many hospitals have shifted away from routinely giving patients opioids during and after major surgeries -- even though it is rare for patients to become chronic opioid users.

A large Canadian study found that only 0.4% of elderly patients that were prescribed opioids while recovering from a heart, lung, colon, prostate or hysterectomy operation were still using them a year after their surgeries.

Another large study published this year in the British Medical Journal found similar results. Only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Long-term opioid use after dental surgeries is also rare. A recent study published in JAMA found that only 1.3% of teens and young adults who were given opioids after wisdom teeth removal were still being prescribed opioids months after their initial prescription.

The vast majority of patients still prefer opioids and perceive them as the most effective form of pain relief after surgery. In a recent survey of over 500 adults who were scheduled to have surgery, researchers at Thomas Jefferson University Hospital in Philadelphia found that 77% expected opioids, 37% expected acetaminophen, and 18% expected a NSAID for pain relief.

"Patients often assume they will receive opioids for pain, believing they are superior, and therefore may pressure physicians to prescribe them after surgery," said lead author Nirmal Shah, DO, an anesthesia resident at Thomas Jefferson University Hospital.

"But research shows opioids often aren't necessarily more effective. Clearly, we need to provide more education to bridge that gap and help patients understand that there are many options for pain relief after surgery, including other pain medications such as acetaminophen and ibuprofen."

Should Roseanne Have Died From an Opioid Overdose?

By Pat Anson, PNN Editor

Roseanne Barr is the latest victim of America's opioid crisis. Or to be more precise, Roseanne Conner is.

The fictional matriarch of ABC’s cancelled “Roseanne” show was killed off in the opening episode of “The Conners” Tuesday night, with her family struggling to come to terms with her death. What was initially thought to be a fatal heart attack turns out to be an accidental overdose of prescription opioids.

TV audiences had last seen Roseanne Conner hiding her addiction to opioid painkillers while waiting for long-delayed and costly knee surgery. But that storyline ended when Roseanne Barr was fired by ABC for a racist tweet and the network had to come up with a way to explain her absence.

“We firmly decided against anything cowardly or far-fetched, anything that would make the fierce matriarch of the Conners seem pathetic or debased,” Executive Producer Bruce Helford explained in The Hollywood Reporter.

“I wanted a respectful sendoff for her, too: one that was relevant and could inspire discussion for the greater good about the American working class, whose authentic problems are often ignored by broadcast television.”

ABC

"I AIN'T DEAD BITCHES," Barr tweeted after watching the show. She followed up with a longer joint statement with her spiritual advisor, Rabbi Shmuley Boteach.

“We regret that ABC chose to cancel 'Roseanne' by killing off the Roseanne Conner character,” the statement said. "That it was done through an opioid overdose lent an unnecessary grim and morbid dimension to an otherwise happy family show.”

It was also a bit of a cliché. The popular perception that most opioid overdoses are due to prescription painkillers is now largely a myth.  According to the Centers for Disease Control and Prevention, nearly 49,000 Americans died from opioid overdoses in 2017, but over half of them were due to illicit fentanyl and heroin, not prescription opioids.

A more accurate way to depict Roseanne’s death would have been through an overdose of heroin or counterfeit painkillers laced with fentanyl. That’s how thousands of Americans are dying. Roseanne Conner could have even been driven to suicide by untreated pain. Imagine what an eye-opening show that would have been.

Instead, the Conner family discovers that Roseanne was hiding painkillers all over the house and sharing them with a group of friends, all of them struggling with pain and addiction. The show makes it appear like opioid medication is easy to obtain, something real pain patients know is no longer true.

The only thing missing from the hackneyed script was someone saying, “If only Roseanne had tried yoga and taken Tylenol, she’d still be alive!”

Executive producer Bruce Rasmussen told Variety last week they thought carefully about how to end Roseanne's character. "You don't want to be flip about how you do this," said Rasmussen.

But that’s exactly how it came across to some PNN readers.

“The media can't seem to get the other side of the story out, nor can they print the truth about exactly how many deaths are the result of PRESCRIPTION opiates,” wrote Stephen Johnston.  “Now millions of folks will be watching as more gas is poured onto the fire. That same fire that's burning up what's left of people like myself and millions of others for whom opiate pain medications are the only relief from whatever traumatic accident or terrible malady has befallen them.”

“It was bad enough when they made pain meds a focus of the rebooted show when the first episode of the show's return aired. Now we have the added stigma, as intractable pain people, of them choosing to have Roseanne die from opioid misuse,” said Jack.

“Don't give the writers, actors, producer, the network hacks, etc., anything that isn't OTC when they have occasion to need pain relief — chronic or acute. Tylenol 3's would be much too generous, as many of us don't even get those.”

You can watch the first episode of “The Conners” by clicking here.

Cutting Rx Opioid Supply Is Not Stopping Diversion

By Roger Chriss, PNN Columnist

Drug diversion is an increasingly important factor in the opioid overdose crisis. A new report from Protenus found that 18.7 million pills, valued at around $164 million, were lost due to drug diversion in the United States during the first half of 2018. This represents a vast increase over 2017, when 20.9 million pills were diverted during the entire year.

As we’ve described previously, drug diversion in the supply chain is a vast, complex and old phenomenon. And it is rapidly worsening.

According to the textbook, “Prescription Drug Diversion and Pain,” drug thefts from hospitals “have increased significantly within the past decade as street prices have climbed sharply for diverted prescription opioids and benzodiazepines.”

In other words, the steep cuts in opioid production that began in 2017 aren’t working. And Attorney General Jeff Sessions was wrong when he said, "The more a drug is diverted, the more its production should be limited." A tightening supply has actually resulted in more diversion.

Drug diversion can be broadly divided into three categories: clinical diversion, personal diversion and industrial diversion. The first, according to Protenus, is drug diversion by healthcare workers. The second is the sale or transfer by a patient who received a legitimate prescription to a third party. And the third is everything else, from diversion by employees at manufacturing facilities to theft in distribution centers or pharmacies.

Personal diversion has gotten substantial attention in recent years. Prescription drug monitoring databases, pain agreements, and urine drug testing are all intended to help prevent such diversion.

Clinical drug diversion is a long-standing problem in healthcare that has garnered more interest recently. The bipartisan opioid bill recently passed by Congress includes a provision that allows hospice workers to destroy opioid medication that has expired or is no longer needed by a patient. The National Institutes of Health has also awarded a grant to further expand efforts to detect opioid and other drug theft in hospital systems.

Industrial diversion is less well known, but appears to be a longstanding problem. In the book “Dopesick,” journalist Beth Macy writes that as early as 2001 the DEA was investigating lax security standards at Purdue Pharma manufacturing plants after the arrest of two Purdue employees accused of trying to steal thousands of pills.

Between 2009 and 2012, over 63,000 thefts of opioids and other controlled substances were reported to the DEA. Pharmacies (66%) and hospitals (19%) accounted for the vast majority of those drug thefts.

And in 2007, an audit of CMS Medicare Part D payments identified 228,000 prescription payments with invalid prescriber identifications for Schedule II drugs.

In other words, tens of thousands of drug thefts and hundreds of thousands of fraudulent prescriptions are occurring annually, leading to millions of prescription pills entering the illegal market. This may help explain how OxyContin entered the black market so quickly and completely.

As Beth Macy writes: “The town pharmacist on the other line was incredulous: “Man, we only got it a month or two ago. And you’re telling me it’s already on the street?””

The National Association of Drug Diversion Investigators and the DEA Diversion Control Division are attempting to address industrial diversion. But available evidence suggests there is much more work needed to secure the entire prescription drug supply chain.

As the opioid overdose crisis continues to evolve toward poly-drug substance abuse, drug diversion will play an increasingly significant role in the illegal supply of prescription pharmaceuticals unless the entire supply chain is secured. This will require far more than the easy tasks of checking a prescription database or legislating pill counts. The hard part of reducing drug diversion remains to be done.

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 Walmart Blacklisting Doctors?

By Pat Anson, PNN Editor

Carolyn Eastin has been a nurse practitioner in Arizona for nearly a decade. She is the only licensed prescriber at a busy pain clinic in Scottsdale, where many patients are on high doses of opioid medication.

Eastin says she was “mortified” by a letter last month from Walmart’s corporate headquarters that said the retail giant’s Walmart and Sam’s Club pharmacies would no longer fill her prescriptions for opioids.

“In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will no longer be able to continue filling your controlled substance prescriptions,” the letter states. “We regret any inconvenience this may cause you or your patients.”

“It was very humiliating. I was upset about it,” says Eastin. “We’ve already had patients who can’t get prescriptions there.”

The unsigned Walmart letter has all the appearances of a form letter. It makes no mention of any complaints against Eastin, whether any of her patients have overdosed, or if her prescribing is medically inappropriate.

Eastin writes prescriptions for nearly 500 chronic pain patients at the Absolute Rehabilitation and Pain Medicine clinic. Most are on high doses of opioids, at levels well above those recommended by the CDC in its 2016 opioid guideline. Eastin believes she was red flagged by Walmart after a prescription database search and is now on a “blacklist” of prescribers.

“I’m the only one who writes prescriptions here. So I would have higher numbers than the average nurse practitioner,” she told PNN. “I’m not doing anything wrong. I’m tapering my patients. I’m trying to do my part to bring people into compliance.”

Does Walmart blacklist doctors who prescribe high doses of opioids? Is Walmart practicing medicine without a license? We posed those questions to Walmart and received a one sentence reply.

“Walmart does not comment on our patients or their prescribers,” wrote Erin Hulliberger, Walmart Corporate Communications in an email.

Corresponding Responsibility

What Walmart is doing isn’t illegal. Under federal law, pharmacists have a “corresponding responsibility” when filling medications -- a legal right to refuse to fill prescriptions they consider unusual or improper. Most pharmacists will call the prescribing doctor to double-check before turning away a patient, but in some cases there’s a “hard edit” – pharmacy jargon for when a company database tells a pharmacist not fill a prescription.

“It may be appropriate for a pharmacy to not fill a prescription because of a dangerous dose or even an inappropriate drug,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.

“However, if they are refusing to fill a prescription because the doctor has met some arbitrary dosage threshold by the company without understanding the circumstances, it would be inappropriate and potentially harmful to the patient.”   

A former Walmart pharmacist told PNN the company closely monitors prescriptions and doctors at every store.

“They had assembled prescription numbers for every doctor who had filled prescriptions at my store. They knew the exact number of medications ordered and sold down to the tablet. They knew what drugs the doctors wrote for and what percentage of the total each drug they wrote for," said the pharmacist, who asked to remain anonymous.

Walmart recently began using Narxcare, a private healthcare database developed by Appriss Health, which analyzes the prescriptions and medical claims of millions of Americans. Every patient evaluated by NarxCare is assigned a “risk score” based on the past two years of their prescription drug use, medical claims, electronic health records and even their criminal history.

Is Walmart using Narxcare data to blacklist doctors? A spokesman for Appriss denies it.

“No, we do not provide provider risk scores to Walmart, or anyone else,” said David Griffin, Vice President of market and communication for Appriss Health.

Prescription Data Mining

The data mining of opioid prescriptions has become increasingly common in healthcare and law enforcement. Doctors, pharmacies, insurers, and federal and state regulators are all using prescription drug databases to look for signs of opioid “overprescribing.”

In addition to Walmart, the Absolute clinic has drawn the attention of the Arizona Medical Board. Last year the clinic’s owner, Dr. Steve Fanto, signed an agreement with the medical board to stop practicing medicine after he was accused of overprescribing Subsys, a potent fentanyl spray.  

Although Fanto is no longer involved in the day-to-day management of the Absolute clinic, it remains under scrutiny. Last December, the clinic was raided by DEA agents, although no charges were ever filed as a result of that investigation. The clinic has also received over a hundred letters from insurer United Healthcare warning about the high dose prescriptions Carolyn Eastin is writing.

“It’s a bullying technique,” says Jessica Webb, the office manager at Absolute. “We’re afraid if we don’t taper down, the insurance companies will file a complaint on Carolyn. If Carolyn’s license is revoked, we’ll have to shut down. She’s the only reason we’re still open.”

Caught in the middle of this tug of war are Absolute’s patients – who could be faced with the difficult task of finding new doctors if the clinic closes. Their painful medical conditions -- and the human suffering that comes with them – appear to be non-factors in Walmart’s decision not to fill Eastin’s prescriptions.

“I can’t tell you the number of patients that made the comment to me, ‘I might as well die. I don’t have any other options but to take my own life because I can’t live without this medication,’” Eastin said. “It’s very difficult to look these people in the eye every single day and say, ‘I want to help you but I’m going to take more away from you.’”

‘I Hope It Doesn’t Harm Patients’

Pain management experts say its unethical to use data mining alone to judge whether a prescription should be filled.

“It appears that Walmart is trying to reduce their risk of being charged with criminal conduct and paying more fines. It is hard to know. But whatever their reason I hope it doesn't harm patients,” said Webster.  

“Without further explanation about the basis for their decision, and without information about any previous interventions attempted by Walmart, this seems remarkably punitive and capricious,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“I would hope that companies that review prescriber records would attempt a series of less drastic interventions with the prescriber before reaching this point. There may be issues of concern, but the appropriate step is to discuss those with the prescriber and try to reach an understanding about what is going on, and about what needs to happen to ensure that everyone is prescribing and dispensing safely. I’d be interested to hear from Walmart about whether they have such a graduated policy and if not, why not.”

Carolyn Eastin says there’s only so much she can do. Abruptly tapering patients or cutting them off from opioids could cause more harm than good.

“We’re trying to follow the CDC guidelines. We’re trying to comply with the insurance letters asking for tapers,” she says.  “I’m doing my part to taper my patients. But these things have to be done delicately. We just can’t go, ‘Okay, give me all your meds.’”  

“We’ve pushed them to get physical therapy and cognitive behavioral therapy, and patients are having good results with that,” says Jessica Webb. “But we have some patients, if I had to take their meds away, I couldn’t go to sleep at night. They’re that sick.”   

Doctors Urge CDC to Clarify Rx Opioid Guideline

(Editor’s Note: Five healthcare professionals recently began circulating an open letter to the CDC asking it to make a “bold clarification” of its controversial 2016 opioid guideline.

They believe many chronic pain patients have suffered under the guideline, because it has led to widespread tapering and discontinuation of opioids. They invited other healthcare professionals to co-sign the letter. To date, well over 200 have.

To see a list of signatories, click here. If you are a healthcare professional and also wish to sign the letter, click here.)  

Authors: Health Professionals for Patients in Pain

Any professional who cares for patients, including physicians, pharmacists, nurses, psychologists and social workers, is invited to sign on to this letter, as are any professional organizations that wish to endorse formally. 

I. In 2016, the Centers for Disease Control and Prevention, CDC, issued a Guideline for Prescribing Opioids for Chronic Pain for primary care physicians. Its laudable goals were to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy. The Guideline reflected the work of appointed experts who achieved consensus on the matter of opioid use in chronic pain. 

Among its recommendations are that opioids should rarely be a first option for chronic pain, that clinicians must carefully weigh the risks and benefits of maintaining opioids in patients already on them, and that established or transferring patients should be offered the opportunity to re-evaluate their continued use at high dosages (i.e., > 90 MME, morphine milligram equivalents).  

In light of evidence that prescribed dose may pose risks for adverse patient events, clinicians and patients may choose to consider dose reductions, when they can be accomplished without adverse effect, and with possible benefit, according to some trial data.  

Nonetheless, it is imperative that healthcare professionals and administrators realize that the Guideline does not endorse mandated involuntary dose reduction or discontinuation, as data to support the efficacy and safety of this practice are lacking.  

II. Within a year of Guideline publication, there was evidence of widespread misapplication of some of the Guideline recommendations. Notably, many doctors and regulators incorrectly believed that the CDC established a threshold of 90 MME as a de facto daily dose limit. Soon, clinicians prescribing higher doses, pharmacists dispensing them, and patients taking them came under suspicion.  

Actions that followed included payer-imposed payment barriers, pharmacy chain demands for the medical chart, or explicit taper plans as a precondition for filling prescriptions, high-stakes metrics imposed by quality agencies, and legal or professional risks for physicians, often based on invocation of the CDC’s authority. Taken in combination, these actions have led many health care providers to perceive a significant category of vulnerable patients as institutional and professional liabilities to be contained or eliminated, rather than as people needing care.  

III. Adverse experiences for these patients are documented predominantly in anecdotal form, but they are concerning. Patients with chronic pain, who are stable and, arguably, benefiting from long-term opioids, face draconian and often rapid involuntary dose reductions. Often, alternative pain care options are not offered, not covered by insurers, or not accessible. Others are pushed to undergo addiction treatment or invasive procedures (such as spinal injections), regardless of whether clinically appropriate.  

Consequently, patients have endured not only unnecessary suffering, but some have turned to suicide or illicit substance use. Others have experienced preventable hospitalizations or medical deterioration in part because insurers, regulators and other parties have deployed the 90 MME threshold as a both a professional standard and a threshold for professional suspicion. Under such pressure, care decisions are not always based on the best interests of the patient. 

lV. Action is Required: The 2016 Guideline specifically states, “the CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted”. The CDC has a moral imperative to uphold its avowed goals and to protect patients.  

Therefore, we call upon the CDC to take action: 

1. We urge the CDC to follow through with its commitment to evaluate impact by consulting directly with a wide range of patients and caregivers, and by engaging epidemiologic experts to investigate reported suicides, increases in illicit opioid use and, to the extent possible, expressions of suicidal ideation following involuntary opioid taper or discontinuation. 

2. We urge the CDC to issue a bold clarification about the 2016 Guideline – what it says and what it does not say, particularly on the matters of opioid taper and discontinuation.  

Signatories here represent their own views, and do not purport to reflect formal positions of their employing agencies, governmental or otherwise.

For questions regarding the letter, please contact Stefan G. Kertesz, MD, Professor of Medicine at University of Alabama at Birmingham School of Medicine (skertesz@uabmc.edu).

The information in this letter 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.

Medicaid Expansion Did Not Fuel Opioid Crisis

By Pat Anson, PNN Editor

A new study is debunking claims that increased access to healthcare and pain management helped to fuel the opioid crisis. If anything, the opposite appears to be the case.

The study, published in the Journal of General Internal Medicine, found that early Medicaid expansions in Arizona, Maine and New York may have led to lower overdose rates in those states.

"These findings suggest that Medicaid expansions were unlikely to have contributed to the subsequent rise in drug overdose deaths, and may even have been protective," said lead author Atheendar Venkataramani, MD, PhD, an assistant professor of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania.

Venkataramani and co-author Paula Chatterjee, MD, looked at state-level data on drug overdoses from 1999 to 2008, comparing overdose mortality rates in the three Medicaid-expansion states to those in other states.

By 2008, Arizona, Maine and New York had about 7 fewer overdose deaths per 100,000 people compared to the other 47 states.

The differences were even greater when the three states were only compared to adjacent states: They had 17 fewer deaths per 100,000 people.

Overall, the study suggests that drug overdose deaths were nearly 20 percent lower in the early expansion states.

"The results should provide reassurance to policymakers who are concerned that state Medicaid expansions, including the recent expansions implemented as part of the Affordable Care Act, promote rises in drug overdose mortality," said Venkataramani.

The Affordable Care Act (ACA) – widely known as Obamacare – greatly expanded Medicaid coverage for millions of poor Americans, starting in 2014. But some critics have claimed the ACA made the opioid crisis worse by giving patients easier access to opioids.

“The Medicaid expansion may be fueling the opioid epidemic in communities across the country,” Wisconsin Sen. Ron Johnson (R) wrote in a 2017 letter to the Health and Human Services inspector general. “Because opioids are so available and inexpensive through Medicaid, it appears that the program has created a perverse incentive for people to use opioids, sell them for large profits and stay hooked.”

The Penn Medicine study wasn't designed to determine why Medicaid expansion appeared to lower overdose death rates in New York, Arizona and Maine. But it does suggest that better access to healthcare was a factor.

“Improving people’s access to health care could have a number of effects. It may be that people had better access to substance use disorder treatment or better access to mental health or pain management. Or it may be that providing health insurance reduced the risk of financial ruin, which helped downward socioeconomic spirals that could lead to substance use disorder,” Venkataramani wrote in an email to PNN.

“If Medicaid expansions did increase access to opioids, then the effect of doing so was far outweighed by other forces that actually reduced mortality rates from drug use order. The mechanisms again are not known because of data limitations in this study, but access to regular health care, access to substance use disorder treatment, and improved socioeconomic circumstances all may have contributed to the slower growth in drug overdose mortality in Medicaid expansion states.”

The Affordable Care Act expanded Medicaid coverage to about 12 million Americans in the 31 states and the District of Columbia that opted to receive it. A recent study found that opioid prescriptions decreased slightly in those states, while prescriptions for addiction treatment drugs like Suboxone rose significantly.

Tennessee’s ‘Absolutely Crazy’ Opioid Law

By Pat Anson, PNN Editor, and Blake Farmer, Nashville Public Radio

Since the CDC released its opioid guideline in 2016, over 30 states have passed legislation that limit opioid prescriptions in some way. Most limit the supply to a few days for initial opioid prescriptions and some set limits on the doses that doctors can prescribe.

Which state has the toughest opioid regulations?

“Tennessee is just absolutely crazy,” says Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

Twillman is referring to a strict and complicated state law that took effect in July that restricts how long Tennessee doctors can prescribe opioids to patients.

“Depending on what you document and depending on your judgement of what’s going on with the patient, you’re either limited to a 3-day supply, a 10-day supply, a 21-day supply or a 30-day supply of an opioid,” Twillman told PNN.

“You wonder how in the world they’re ever going to police this. If it’s a particularly severe case you could do a 21-day supply, but if it’s a rare case then you can do a 30-day supply. What is the difference?”

Tennessee also limits the dose that doctors prescribe, under a complicated formula that lowers the allowable dose the longer a prescription lasts. In other words, you may get more pills but the dose will be smaller.

Any “significant deviation” from Tennessee’s opioid law could result in disciplinary action for a doctor not showing “sound medical judgment.” First offenders could be banned from prescribing opioids for five years.

“They’ve left us saying make your own best judgement and document the reason for it and cross your fingers and hope you’re going to be okay,” says Twillman.

Some doctors have decided not to take that risk. Many primary care providers in Tennessee have stopped prescribing opioids and are referring patients to the state’s dwindling supply of pain clinics, where waiting lists are long and there’s no guarantee a new patient will even be able to get treatment.

Insurers Drop OxyContin

But it’s not just legislation that limits how pain patients are being treated in Tennessee. Insurance companies are refusing to pay for some opioids.

The largest insurer in Tennessee recently announced it will no longer cover prescriptions for OxyContin, what was once a blockbuster pain reliever. It’s the latest insurance company to turn against OxyContin, whose maker, Purdue Pharma, faces dozens of lawsuits related to its high-pressure sales tactics around the country and contribution to the opioid crisis. Last fall, Cigna and Florida Blue both dropped coverage of the drug.

Top officials at BlueCross BlueShield of Tennessee (BCBST) say newer abuse-deterrent opioids work better than OxyContin, and starting in January, the insurer covering 3.5 million Tennesseans will only pay for opioids made by other pharmaceutical companies.

“We felt it was time to move to those products and remove Oxycontin from the formulary, which does still continue to have a higher street value,” said Natalie Tate, the insurer’s vice president of pharmacy.

OxyContin was reformulated in 2010 to make the drug harder to misuse — but it’s still possible to crush or liquefy in order to snort or inject it.

The latest long-acting opioids that BlueCross BlueShield of Tennessee is going to start covering — Xtampza and Morphabond — are still more difficult to misuse, according to the company and some pharmaceutical experts.

Practicing pain physicians in Tennessee — who regularly battle with insurance companies —  approve of the change, though they said OxyContin was already falling out of favor. And they argue trading one opioid for slightly safer ones doesn’t address a larger gripe that physicians have with insurers over paying for other, non-addictive types of treatment.

“We will have denials and prior authorizations on a muscle relaxer, and we will have no issue getting an opioid through the insurance company,” said Dr. Stephanie Vanterpool, an anesthesiologist at the University of Tennessee and the president-elect of the Tennessee Pain Society.

“The physicians or the doctor’s offices jump through hoops to get the better medication for the patients,” said Vanterpool. “And when I say better medication, I mean the medication that’s treating the cause of the pain, not just the medication that’s covering up the pain.”

Not to say OxyContin won’t be sorely missed by some patients.

“There are plenty of people who benefit from that drug,” said Terri Lewis, a patient advocate and rehabilitation specialist from Cookeville, Tenn.

Lewis is suspicious of BCBST’s motives since the insurer may be blamed for its role in the opioid crisis. Embattled Purdue Pharma could also be a convenient scapegoat.

“Maybe this is a good decision,” Lewis said. “But it smells like a political decision.”

This would be just the latest decision inserting politics into a nuanced medical problem that affects millions of pain patients.

John Venable of Kingsport, Tenn., was shown the door by his pain clinic in July after more than a decade on oxycodone — a generic, short-acting version of OxyContin.

“I just felt like I was in a hopeless state, like, ‘there is no help for John,'” he recalled.

At their worst, he said his headaches get so debilitating “that death would be a relief.” Despite his dread, he’s noticed something surprising over the last few months without opioids — his crippling headaches haven’t gotten that much worse, if at all.

“It very well might be a blessing in disguise,” Venable said.

The retired builder and one-time pastor said he prays that those losing OxyContin also will get to use the moment as an opportunity, though he knows many can’t cut ties with opioids. And he worries some will turn to more dangerous drugs off the street or even contemplate ending their own lives.

Experts point out that the number of opioid prescriptions has already been falling around the country. And in Tennessee, BCBS has experienced a 26 percent drop in opioid prescription claims over three years.

But restricting legal access to opioids hasn’t turned back the rise in overdose deaths, which hit a record in Tennessee and nationwide last year.

This story is part of a partnership that includes Nashville Public Radio, NPR and Kaiser Health News.

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.

Lyrica Not Effective for Treating Traumatic Nerve Pain

By Pat Anson, Editor

Pregabalin is not effective in relieving chronic pain caused by traumatic nerve injury, but it may be useful as an analgesic in treating pain after surgery, according to a new study published in the Journal of Neurology.

The placebo-controlled study followed 539 patients in North America, Europe, Africa and Asia for three months. About half had nerve pain after surgery, while the rest had nerve pain after an accident or trauma.

Researchers found that pregabalin was not an effective pain reliever for the patients with traumatic nerve injuries, but the drug did provide better pain relief than placebo for the surgery patients.

"While these finding show that pregabalin is not effective in controlling the long-term pain for traumatic injury, it may provide relief for patients (that) experience post-surgical pain," said lead author John Markman, MD, director of the Translational Pain Research Program in the University of Rochester Department of Neurosurgery.

"The possibility that there was pain relief for those patients who had a hernia repair, or breast surgery for cancer, or a joint replacement lays the groundwork for future studies in these post-surgical syndromes where there is so much need for non-opioid treatments."

Pregabalin, which is sold by Pfizer under the brand name Lyrica, is FDA-approved for the treatment of chronic pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy.

It is also commonly prescribed as an "off label" treatment for other types of chronic pain and as an alternative to opioid medication.

A major challenge for doctors is that biological changes in nerves and other tissues while healing from surgery or trauma vary from one patient to the next. There is also no diagnostic method that allows doctors to identify which patients will respond to a particular type of pain treatment.

"Given the rising rates of surgery and shrinking reliance on opioids, it is critical that we understand how to study new drugs that work differently in patients like the ones included in this study," Markman added.

While critics often say there is little or no evidence to support the long-term use of opioids, the same is true for other types of pain medication, including pregabalin. Nevertheless, in its guideline for opioids, the Centers for Disease Control and Prevention recommends pregabalin and its chemical cousin gabapentin as alternatives for treating chronic pain – without even mentioning their side effects or potential for abuse.

Pregabalin and gabapentin belong to a class of nerve medication called gabapentinoids, which were originally developed to treat epilepsy, not pain. In recent, deaths involving gabapentinoids have increased in the UK, Australia and Canada, where some addicts have learned the drugs can heighten the euphoric effect of heroin and other opioids.

The use of pregabalin and gabapentin has tripled in the U.S. over the past decade, but health officials have only recently started looking into their misuse and abuse. While gabapentin has a warning label cautioning users who take the drug with opioids, there is no similar warning for pregabalin.

Overdose Crisis Began 40 Years Ago

By Pat Anson, PNN Editor

The overdose crisis in the United States began long before a spike in opioid prescribing and is likely to last for many more years, according to a new study published in Science magazine.

Researchers at the University of Pittsburgh Graduate School of Public Health looked at nearly 600,000 poisoning deaths in the U.S. from 1979 to 2016 and found a steadily rising number of overdoses caused by “subepidemics” of different drugs, including heroin, cocaine, illicit fentanyl, methamphetamine and prescription opioids. As each subepidemic rose and fell, the drug fueling it was replaced by another substance that can be abused.

“The epidemic of drug overdoses in the United States has been inexorably tracking along an exponential growth curve since at least 1979, well before the surge in opioid prescribing in the mid-1990s,” said senior author Donald Burke, MD, Pitt Public Health dean and UPMC-Jonas Salk Chair of Global Health. 

“Although there have been transient periods of minor acceleration or deceleration, the overall drug overdose mortality rate has regularly returned to the exponential growth curve. This historical pattern of predictable growth for at least 38 years strongly suggests that the epidemic will continue along this path for several more years.”

Burke and his colleagues say the type of drug and the demographics of those who die from overdoses has fluctuated over the years. When the use of one drug waned, another drug replaced it, attracting new populations from different geographic regions.

When plotted on a map, certain drugs dominate different areas. Almost every region in the country is a hot spot for overdose deaths from one or more drugs. Heroin and cocaine primarily impact urban populations, while prescription opioids and methamphetamine skew a bit more rural. Cocaine increased death rates for black men, while heroin raised the death rates for younger whites and older blacks.

To be successful, researchers say overdose prevention efforts must extend beyond control of individual drugs. The current subepidemic of drug deaths caused by illegal and legal opioids will likely to be replaced by something else.

“The recent historical variability with which some specific drugs have waxed and waned makes predictions about the future role of specific drugs far more uncertain. Indeed, it is possible that in the future, the drug overdose epidemic may be driven by a new or heretofore obscure psychoactive substance,” Burke warned. 

Click on the video below to see a chart of the different subepidemics and how they align to form an exponential growth curve:

Technological factors fueling the epidemic include enhanced communication methods (smartphones and the Internet), faster supply chains (FedEx and UPS) and underground drug manufacturing that increased the supply of drugs while lowering their cost. Socioeconomic factors such as unemployment, lost social connections and lack of healthcare may also be creating a climate of despair that leads to drug abuse. 

“Understanding the forces that are holding multiple subepidemics together into a smooth exponential trajectory may be important in revealing the root causes of the epidemic, and thisunderstanding may be crucial to implementation of prevention and intervention strategies,” Burke said. 

“Evidence-based public health responses have contained past epidemics. If we understand and address these root causes at the same time that we take on the opioid crisis, we should be able to curb the epidemic for good."

‘Don’t Punish Pain’ Rallies Draw Local Media Coverage

By Pat Anson, PNN Editor

Hundreds of people – including some in wheelchairs and others on crutches – took part in a nationwide series of rallies Tuesday protesting the poor treatment of chronic pain patients.

“Don’t Punish Pain” rallies were held in over 80 cities from Anchorage, Alaska to Jacksonville, Florida. The protests were organized on Facebook by a grassroots group of pain patients, including many who have lost access to opioid medication or seen their doses drastically reduced due to federal and state guidelines that target opioid prescribing.   

Rally organizers were disappointed by the low turnout in some cities. Only a handful of people showed up for rallies in Las Vegas and Providence, Rhode Island. But over a hundred patients and their supporters rallied in Oklahoma City. And about two dozen people rallied on the steps of the state capitol in Olympia, Washington.

Due to their small size, the rallies have yet to attract the national media attention that organizers are hoping for.

But they have been successful in drawing local media coverage and getting reporters to tell a side of the “opioid crisis” that’s rarely addressed.

DON’T PUNISH PAIN RALLY IN OLYMPIA, WASHINGTON

“We’re invisible. We’re hidden in our homes and our beds and in our rooms,” Crystal Irwin told CBS4 News at a rally in Denver. “People don’t know what we’re going through.”

Ben Lawrence has lived with chronic pain since an accident in 2009. He told CBS4 he was still able to work until his doctors stopped giving him opioids.

“They make you feel like you’re a drug addict,” Lawrence said. “They don’t give me the medication I need to go to work. I want to go to work.”

Rally organizers in Stuart, Florida told ABC25 News that patients are being unfairly targeted in the opioid crisis when the real problem is illicit drugs.

"They are calling this an opioid crisis when actually it's a fentanyl crisis, and they can't control the drugs coming into the United States. But they can control people like us who get our pain medication to survive," said Michael Courtright.

Patients are calling for major changes in guidelines released by the CDC in 2016, which discourage doctors from prescribing opioids for chronic pain. Although voluntary and only intended for primary care physicians, the guidelines have been widely adopted as mandatory by insurers, regulators and healthcare providers.

“Chronic pain patients all across the country are losing access to their pain medications that they depended on sometimes for 20 or 30 years,” Kristen Blanton told Fox55 News in Urbana, Illinois.

Don’t Punish Pain organizers held their first nationwide rallies in April and are planning another series of protests in January.

FDA Expands Safe Prescribing Program for Opioids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration will require that educational training in pain management and safe opioid prescribing be offered to all healthcare providers under a major expansion of the agency’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program.

REMS is also being expanded to include immediate-release (IR) opioids such as hydrocodone, oxycodone and morphine. Until now, REMS regulations only applied to extended-release and long-acting (ER/LA) opioid analgesics, such as OxyContin and Exalgo. Warning labels will be updated for all IR opioids, which account for about 90 percent of opioid pain medications.

“Many people who become addicted to opioids will have their first exposure in the medical setting,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements.”

The REMS program was first established in 2012. It required manufacturers of ER/LA opioids to pay for continuing education programs for prescribers only. Updated educational content must now also be provided to nurses, pharmacists and other healthcare providers who seek it. The training will cover broader information about pain management, including alternatives to opioids for the treatment of pain.

The training is not mandatory, but the FDA is considering whether to require continuing educational programs in pain management and safe prescribing.

“The agency believes that all health care providers involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight,” the agency said.

“I think these changes to the REMS are very good and long overdue,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management. “We know that the IR opioids are much more highly sought-after, versus ER/LA opioids, for purposes of abuse, and there is absolutely no reason why they (and their manufacturers) should be exempt from this requirement.  

“I’m not concerned, at this stage, about this change causing primary care providers to back off on prescribing, given that participation in the program is still completely voluntary for healthcare providers. If this voluntary status changes, and FDA finds a way to make REMS education mandatory, I will be concerned that some providers will opt out of prescribing opioids altogether.”

The FDA’s action greatly expands the number of opioid products covered by REMS from 62 to 347 opioid analgesics. The updated warning labels will strongly encourage providers to complete a REMS education program, and to counsel patients and caregivers on the safe use of opioid medication.

“Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines,” said Gottlieb.

Opioid prescriptions in the United States fell sharply during the first half of 2018 and now stand at their lowest levels since 2003, according to data released last month by the FDA. The trend appears to be accelerating as many doctors lower doses, write fewer prescriptions or simply discharge pain patients.

While opioid prescriptions decline, overdoses continue to rise. According to preliminary data from the CDC, nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl, heroin and counterfeit drugs, not prescription opioids.

Former Tennant Patients Get New Doctor

By Pat Anson, PNN Editor

At a time when many pain patients have difficulty finding doctors willing to treat them, some of the sickest and most complicated pain patients in the U.S. have found a new physician. Or to be more precise, she found them.

Dr. Margaret Aranda is treating former patients of Dr. Forest Tennant, a prominent California pain physician who recently retired from clinical practice.  Tennant was seeing about 150 patients with severe intractable pain at his West Covina pain clinic. Most suffer from arachnoiditis, a chronic and painful disease of the spinal cord, and traveled to California from out-of-state because they could not find effective treatment locally.

Tennant, who is 77, is a beloved figure in the pain community. He was forced into retirement after the DEA raided his clinic last year and alleged he was running a pill mill. No charges were ever filed, but Tennant reluctantly agreed to close his clinic on the advice of his lawyer and doctor. That’s when Aranda stepped in and offered to take on Tennant’s patients.

“I feel very happy to be here and to be doing this and to feel qualified to do it because of my experience, my background and my education. But I think the thing I love the most is the connection I have with patients who understand that I’ve been through a lot myself,” said Aranda, an anesthesiologist whose medical career was put on hold for several years while she recovered from a car accident that left her with traumatic brain injuries.

“They just seem be relieved that they can talk to somebody who knows what it feels like. I think Dr. Tennant did that for them too. He wasn’t sick like a lot us were sick, but he carried that empathy with him. I find this to be very spiritual. I feel like I’m in the right place at the right time in my life and everything I went through prepared me for this.”

DR. MARGARET ARANDA

Tennant had success treating patients with an unusual combination of high dose opioid prescriptions, hormones, anti-inflammatory drugs and other medications, which Aranda plans to continue.

“I’m working to decrease the opioids as much as possible. For some patients that’s totally impossible, for others it’s not,” she told PNN. “I really think what we’re doing is redefining palliative care. I tell people this isn’t a pain clinic. This is a ‘keep you out of a wheelchair’ clinic. Keep you in the family. Keep you getting out of your house here and there.”

“Dr. Aranda is very intelligent and picked up on the scientific precepts of this disease and other things very rapidly,” says Tennant. “I was tickled to death the way she’s caught on to all this and knows how to carry on everything I was doing. Plus, she’s improving a lot of things I was doing.”

Under a Microscope

Aranda admits being a little worried about being scrutinized by the DEA.

“Of course, that would be the natural inclination I think for anyone in my field. It’s a little bit scary to walk in the shoes of a man who is so well known and beloved by everyone and had issues with the DEA I think most people felt were unfounded,” Aranda said.

“I am of course very concerned that they could be looking at me with a microscope. Or a double and triple microscope. But I think they already know our patient population and they now understand that we do have some of the sickest patients in the country. That’s why they come to us from all over. And so, we’re just careful.”

While Tennant operated his clinic basically as a charity, Aranda is “cash only” and will not accept medical insurance.  She is temporarily seeing patients at a clinic in Malibu but is looking for a permanent location.

Like Tennant, Aranda is willing to treat patients from out-of-state, including those who suffer from severe intractable pain. Patients interested in seeing Aranda can reach her at (800) 992-9280.   

DR. FOREST TENNANT

As for Tennant, he’s not quite ready to retire completely. He plans to continue researching arachnoiditis, a progressive and incurable disease that often begins when the spinal cord is damaged during surgery or punctured by a misplaced needle during an epidural steroid injection.

Inflammation sets in and can spiral out of control, forming scar tissue that cause spinal nerves to stick together. That leads to adhesive arachnoiditis and neurological problems, which can cause burning or stinging pain that can be felt from head to toe.

Arachnoiditis is poorly understood and often misdiagnosed as “failed back syndrome.” Tennant estimates as many as a million Americans may have it. Few doctors are trained to recognize the symptoms or know how to treat it.

“I’m going to be spending my time trying to research and educate on arachanoiditis. I think it’s the biggest, most severe pain problem we have,” says Tennant. “Before I hang up my spurs totally I want to make sure arachnoiditis is known to every family doctor and nurse practitioner in every community in the country.”

The Role of Suicide in the Opioid Crisis

By Roger Chriss, PNN Columnist

Suicide is an under-appreciated factor in the opioid crisis. Media reports rarely mention it, and pundits and politicians often ignore it. But the reality emerging from experts and a careful study of drug deaths shows that it is very important.

“We’ve done preliminary work suggesting that 22 to 37 percent of opioid-related overdoses are, in fact, suicides or suicide attempts,” Bobbi Jo Yarborough, PsyD, an investigator at the Kaiser Permanente Center for Health Research, told HealthItAnalytics.

Yarborough’s estimate is 2 to 3 times higher than the CDC’s. The CDC’s Annual Surveillance Report of Drug-Related Risks and Outcomes states that there were 5,206 suicides among the 47,105 poisoning deaths in 2015. This represents a suicide rate of 11 percent. The CDC gives similar data for 2016 drug deaths, estimating that only 8% were suicides.

Recognition of the importance of suicide in the opioid crisis has been slow to come.

In 2017, then-president of the American Psychiatric Association, Dr. Maria Oquendo, suggested that the suicide rate may be as high as 40 percent, writing in a guest blog for the National Institute on Drug Abuse (NIDA) that the risk for suicide death was over 2-fold for men with opioid use disorder and for women it was more than 8-fold.

Now, finally, interest in this issue is growing. The American Foundation for Suicide Prevention recently issued its first grant for studying suicide related to opioid use.

Kaiser Permanente also recently received a grant from NIDA to “examine the role of opioid use in suicide risk and develop better tools to help clinicians identify patients who are at highest risk.”  Kaiser researchers plan to use machine learning and analytics to predict the likelihood of a suicide attempt within 90 days of a primary care outpatient or mental health visit.

Fundamental questions about suicide in the opioid crisis remain to be answered.

"No one has answered the chicken and egg (question)," Dr. Kiame Mahaniah, a Massachusetts family physician, told NPR. “(Do people) have mental health issues that lead to addiction, or did a life of addiction then trigger mental health problems?”

Similarly, people with chronic pain disorders are thought to be “at increased risk for suicide compared with the general population,” as noted in a 2018 PAINWeek conference presentation.

But causality is also uncertain. At present it is not clear what proportion of suicides in the opioid crisis are due to despair, anxiety, addiction or the increasingly poor quality of pain care. There are many anecdotal reports of pain patient suicides, a tragically ignored feature of the crisis.

These distinctions are critical for public health policy in the opioid crisis. Current policy is largely geared toward restricting the opioid supply and monitoring legal pills after prescription. This does little to address underlying mental health issues, illegal drug use, or the impact of psychosocial or economic circumstances on people.

We need a clearer understanding of the opioid crisis, and that includes suicide.

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.

Widely Used Painkiller Raises Risk of Heart Problems

By Pat Anson, Editor

The most widely used painkiller in the world should be banned as an over-the-counter drug because it significantly raises the risk of cardiovascular problems and gastrointestinal bleeding, according to a large new study published in the British Medical Journal (BMJ).

Diclofenac is not well-known in the United States, but it is the most widely used non-steroidal anti-inflammatory drug (NSAID) in the world. It is sold both as a prescription and over-the-counter medication under various brand names such as Voltaren, Cambia, Zorvolex and Solaraze.

Researchers looked at healthcare data from over 6 million people in Denmark from 1996 to 2016 and found that those who used diclofenac were 50 percent more likely to have cardiovascular problems such as atrial fibrillation, heart failure and stroke in the first 30 days compared to those who took nothing. Their risk of gastrointestinal bleeding was also higher.

Out of every 1,000 people who used diclofenac, the study estimated that four additional people would develop a major health problem within a year.

"It is time to acknowledge the potential health risk of diclofenac and to reduce its use. Diclofenac should not be available over the counter, and when prescribed, should be accompanied by an appropriate front package warning about its potential risks," wrote lead author Morten Schmidt, MD, Aarhus University Hospital.

"Treatment of pain and inflammation with NSAIDs may be worthwhile for some patients to improve quality of life despite potential side effects. Considering its cardiovascular and gastrointestinal risks, however, there is little justification to initiate diclofenac treatment before other traditional NSAIDs."

This is not the first time that researchers have warned about the health risks associated with diclofenac and other NSAIDs.

In 2016, researchers at 14 European universities and hospitals, including a number of leading heart specialists, warned that some NSAID’s raise cardiovascular risk and that there is no "solid evidence" the drugs are safe.

Some of the greatest cardiovascular risk comes from a class of NSAIDs known as COX-2 inhibitors. A COX-2 inhibitor called Vioxx was voluntarily pulled from the market by Merck in 2004, but many other COX-2 inhibitors, such as diclofenac, are still widely used for pain relief.   

Another 2016 study published in the BMJ found that use of any NSAID was associated with a 20 percent higher risk of being hospitalized with heart failure. These seven NSAIDs were found to be the riskiest:

• diclofenac
• ibuprofen
• indomethacin
• ketorolac
• naproxen
• nimesulide
• piroxicam

NSAIDs are used to alleviate pain and reduce inflammation, and are found in a wide variety of over-the-counter products – from headache relievers to cold and flu remedies. They are used in so many different products -- such as Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

In 2015, the U.S. Food and Drug Administration ordered warning labels for all NSAIDs to be strengthened to indicate they increase the risk of a fatal heart attack or stroke. The FDA said studies found the risk of serious side effects can occur in the first few weeks of using NSAIDs and could increase the longer people use the drugs. The revised warning does not apply to aspirin.

The European Society of Cardiology recommends limited use of NSAIDs by patients who are at increased risk of heart failure. Those already diagnosed with heart failure should refrain from using NSAIDs completely.