Arizona Drug Bust Shows Fentanyl Crisis Growing

By Pat Anson, PNN Editor

In one of the largest fentanyl busts in state history, nearly 170,000 counterfeit pills made with illicit fentanyl have been seized in Phoenix, Arizona. A DEA task force and Phoenix police seized the pills during a traffic stop on January 22, arresting two suspects who were under surveillance.

The blue pills were stamped with an “M” and a “30” – distinctive markings for 30mg fake oxycodone tablets known on the street as “Mexican Oxy” or “M30.” The total street value of the drugs was estimated at $3 million.

"These 169,000 pills, it can have a varying amount of fentanyl. They have no quality control, and what makes them that much more deadly is they look like legitimate oxycodone pills. They don't contain an active ingredient. It is just fentanyl with other ingredients," said DEA Spokesperson Erica Curry. 

"We are talking about a very deadly substance in such small quantities it can be lethal to anyone who doesn't have an opioid tolerance built up."

DEA PHOTO

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. Counterfeit pills laced with illicit fentanyl have been appearing around the country and are linked to thousands of overdose deaths. In 2019, law enforcement agencies seized over 1.4 million fentanyl pills in Arizona alone.

According to a recent DEA analysis, about one in every four counterfeit pills have a potentially lethal dose of fentanyl.

Street Drug Users Aware of Fentanyl

Who would be foolish or desperate enough to take a street drug that might kill them? Do overdose victims even know the fake pills they’re buying contain fentanyl?

The answer in many cases is yes, according to a new study of street drug users in Vancouver, British Columbia – the first major North American city to see an influx of illicit fentanyl.  

The study drew on data collected from over 300 people recruited at drug treatment sites in 2018. The participants completed a brief survey on their drug use and provided a urine sample that researchers tested for fentanyl and other substances.

About 60 percent of those tested had fentanyl detected in their urine. Of those, nearly two-thirds (64%) knew they had taken fentanyl.

"This research shows the majority of people who use fentanyl know they're doing so," says Dr. Jane Buxton, an epidemiologist and professor at the University of British Columbia, who is corresponding author of the study published in the International Journal of Drug Policy.

"Making people who use drugs aware of the presence of fentanyl in the drug supply isn't enough; we need harm reduction services, substance use treatment, overdose prevention resources, and pharmaceutical alternatives to the toxic drug supply to reduce the devastating impact of fentanyl and its analogues on our communities."

The fentanyl crisis in British Columbia is growing worse by the year.  A similar study in 2015 found only 29% of participants tested positive for fentanyl, with only 27% aware that they'd used it.

When fentanyl first appeared in the illicit drug supply, many users took fentanyl unknowingly because dealers secretly added it to heroin, counterfeit pills and other street drugs. It’s no secret today. According to preliminary data from the BC Coroner, fentanyl or its analogues were found in 85 percent of fatal overdoses in 2019.

Researchers do not fully understand the reasons people knowingly take fentanyl. Some users are aware it is present in the illicit supply of opioids and have no other choice, while others may prefer the experience of taking fentanyl.

"This research lays groundwork that will help us learn more about why fentanyl use is increasing," said lead author Mohammad Karamouzian, a PhD student at UBC's School of Population and Public Health. "These findings will also contribute to more effective messaging campaigns and harm reduction strategies to help reduce preventable deaths and support the health of people who use substances, their families, and their communities."

Another key finding of the study was that people who used fentanyl were more likely to have also recently used heroin or crystal meth.  Those who used cannabis were less likely to use fentanyl.

Surgery Patients Given Tylenol for Post-Operative Pain

By Pat Anson, PNN Editor

Another hospital is touting the benefits of not giving opioid analgesics to patients after minimally invasive surgeries.

Surgeons at Houston Methodist Hospital say they were able to significantly reduce opioid prescriptions given to patients recovering from hernia repair, reflux surgery and other minimally invasive GI-related procedures by treating them with acetaminophen (Tylenol) for post-operative pain.

In a study involving over 400 surgery patients reported in the Journal of Thoracic and Cardiovascular Surgery, Houston Methodist surgeons compared patients treated with acetaminophen to a control group of patients given opioids.

Patients who were treated with acetaminophen had fewer post-operative complications (3%) than those given hydrocodone or tramadol (15%).  They were also significantly less likely to be discharged from the hospital with an opioid prescription than patients in the control group (10% vs. 87%).  

"Just a decade ago we routinely prescribed narcotics to treat pain at home after surgery," said lead author Min Kim, MD, head of the division of thoracic surgery at Houston Methodist Hospital. "We wanted to determine if we could manage pain at home after surgery with over-the-counter pain medication. We developed and implemented the pre-emptive pain control program, which led to excellent pain control at home without requiring prescription narcotics."

Patients in the pre-emptive pain management group received long-acting local anesthetics at each incision. They were also given scheduled doses of acetaminophen or naproxen in the hospital and at home.

"This study provides us with a strategy to successfully manage pain after surgery using over-the-counter pain medication. This led to fewer narcotic prescriptions which proactively decreases the chance of patients becoming addicted to narcotics," Kim said.

Opioid Addiction Rare After Surgery

Few patients actually become addicted after surgery. A 2016 Canadian study, for example, found that long term opioid use after surgery is rare, with less than one percent of older adults still taking opioids a year after major elective surgery.

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

Nevertheless, many hospitals have reduced their use of opioids or stopped giving them to patients altogether.

A statewide effort in Michigan reduced the number of opioid pills given to patients after common operations from an average of 26 pills per patient to 18. The surgeries included minor hernia repair, appendix and gallbladder removal, and hysterectomies. Most were minimally invasive laparoscopic surgeries.

In Ohio, patients at Akron General Hospital are getting acetaminophen, gabapentin and non-steroidal anti-inflammatory drugs (NSAIDs) to manage their pain after elective colorectal operations. Surgeons say over 75 percent of them are sent home without an opioid prescription.

And in Vermont, a 2017 state law requires doctors to use non-opioid pain relievers as first-line treatments for post-operative plan. If they are prescribed opioids, patients are initially limited to no more than 10 pills.

Houston Methodist Hospital is expanding its pre-emptive pain management program to include patients recovering from pulmonary surgery.

Production of Two Excedrin Brands Halted

By Pat Anson, PNN Editor

Spot shortages of Excedrin are being reported after a pharmaceutical company halted production of two leading brands of the pain reliever due to “inconsistencies” in their ingredients.

GlaxoSmithKline (GSK) says consumers are not at risk, but as a precaution it has indefinitely suspended all production and distribution of Excedrin Extra Strength and Excedrin Migraine.

“Through routine quality control and assurance measures, we discovered inconsistencies in how we transfer and weigh ingredients for Excedrin Extra Strength Caplets and Geltabs and Excedrin Migraine Caplets and Geltabs,” GlaxoSmithKline said in a statement.

“Based on the available data, GSK believes that the product does not pose a safety risk to consumers. However, as a precautionary measure, GSK Consumer Healthcare has voluntarily implemented a discontinuation of production and distribution.”

Some drug stores in upstate New York have already run out of Excedrin Extra Strength and Excedrin Migraine. GSK said other Excedrin products are still available and urged consumers to ask their pharmacist for advice on alternative pain relievers.

“We are working hard to resolve the issue as quickly as possible, but at this point in time cannot confirm a definite date as to when supply will resume,” the company said.

In 2012, an Excedrin manufacturing plant in Lincoln, Nebraska was shut down for several months after Excedrin bottles were found to contain broken tablets and stray tablets for other medications. That led to a recall and shortages of Excedrin products around the world.

At the time, the Excedrin brand was owned by Novartis. An FDA investigation found that Novartis failed to adequately investigate hundreds of consumer complaints of foreign products found in over-the-counter drugs produced at the Nebraska plant. Novartis spent millions of dollars re-tooling the plant and shifted some production to third-party manufacturers.

GSK now holds majority ownership of Excedrin through a joint venture with Novartis. GSK did not say where the new production problems originated.

FDA Approves Cocaine Nasal Spray

By Pat Anson, PNN Editor

FDA advisory committees have taken a dim view of opioid medications recently, soundly rejecting new drug applications for the “opioid of the future” oxycodegol and a new extended-release version of oxycodone.

There was also a split 13-13 vote on a relatively mild opioid painkiller – a combination of tramadol and the anti-inflammatory drug Celebrex..

Advisory committee recommendations are not binding on the FDA, but the votes reflect a growing reluctance to approve any new medication that may worsen the so-called opioid epidemic.

"We can't approve a drug in the midst of a public health crisis," said advisory committee member Steve Meisel, PharmD, who voted no on oxycodegol.

FDA advisors may be rejecting opioids out of hand, but cocaine is a different story. The agency this month quietly approved a nasal solution containing cocaine hydrochloride (HCI) for use as a local anesthetic. The nasal spray, made by the Lannet Company, is intended to relieve pain in mucous membranes during surgeries and procedures in the nasal cavities of adults.

"The FDA's approval of our Cocaine HCl product, the first NDA approval to include full clinical trials in the company's history, marks a major milestone in Lannett's 70+ years of operations," said Tim Crew, chief executive officer of Lannett in a news release.

"We believe the product has the potential to be an excellent option for the labeled indication. We expect to launch the product shortly, under the brand name Numbrino."

Numb-rino. Get it?

While cocaine is well-known as a drug of abuse, it is classified by the DEA as a Schedule II controlled substance, alongside hydrocodone and oxycodone. Cocaine’s use in medicine is not unheard of. It was commonly used as an alternative to morphine in the last half of the 19th Century until it fell out favor because of high rates of addiction.

Numbrino is not the first nasal spray containing cocaine to be approved by the FDA. In 2017, the agency approved the nasal solution Goprelto, which is also intended for use during surgeries and procedures in nasal cavities. 

Nevertheless, the FDA’s approval of a drug containing cocaine was so unusual that Snopes conducted a fact check to see if it was true. An FDA spokesperson confirmed to Snopes that Numbrino was approved, along with warning labels and other safeguards to discourage its abuse.

“Cocaine hydrochloride nasal solution contains cocaine, a Schedule II substance with a high potential for abuse. However, when used according to the directions provided in the labeling, physical dependence and withdrawal symptoms are unlikely to develop because this drug is for single use during diagnostic procedures and surgeries,” the FDA said.

“To minimize these risks, the labeling suggests that health care facilities using the drug implement effective accounting procedures, in addition to routine procedures for handling controlled substances. Notably, this will be used as an anesthetic by trained health care professionals during diagnostic procedures and surgeries, not by patients directly. It is not available by prescription.”

Numbrino was approved without any of the controversy that surrounds opioid painkillers. In 2018, the FDA’s approval of Dsuvia — a single use opioid intended for severely wounded soldiers and trauma patients — was panned by critics, who called the drug a “dangerously unnecessary opioid medication." Like Numbrino, Dsuvia is not available by prescription and can only be administered by a healthcare professional.

Public Officials Ignorant About Overdose Crisis

By Christopher Piemonte, Guest Columnist

A recent Washington Post article highlights an ongoing debate between the Drug Enforcement Administration and some public officials, who are demanding that DEA further reduce the supply of opioid medication. DEA has responded that, without more precise data, such a reduction would be ineffective and dangerous for Americans that need opioids.

At the center of the debate is the Aggregate Production Quota (APQ) for Schedule I and II opioids and other controlled substances. Every year, the DEA sets the maximum amount for each substance that can be produced. DEA began cutting the opioid supply in 2017 and has proposed further cuts in 2020.  

Congressional lawmakers and state attorneys general argue that the APQ for opioid medication is still too high, and the excess supply leads to overdose deaths. In a recent letter to the Acting Administrator of DEA, six attorneys general claim that the APQ does not account for opioids diverted to the black market, which “factor in a substantial percentage of opioid deaths.”

Citing data from the CDC, they assert that in 2016 “opioids obtained through a prescription were a factor in over 66% of all drug overdose deaths.”

There’s a problem with these claims: They’re wrong.

When asked about the accuracy of the letter, a spokesperson for CDC said prescription opioids were a factor in “approximately 27% of all drug overdose deaths,” a figure nearly 40% lower than that presented in the letter.

It would be one thing if this error were simply a typo or miscalculation. But these state officials, as well as many lawmakers, are insisting on a specific policy response without having made the effort to dig into the data and understand the nature of the problem itself. Specifically, they cite inaccurate data to support the incorrect notion that “prescription opioids have been a dominant driver in the growing crisis.” What’s worse, that false notion is the basis for their intransigent insistence on a blanket reduction in the supply of all prescription opioids.

Experts in law enforcement, medicine and policy agree that the attorneys general made an erroneous factual conclusion, and that an arbitrary opioid quota reduction would be both ill-informed and dangerous.

“There is no question that the DEA, or any agency, attempting to come up with valid quotas for controlled substances will find it difficult if not impossible. One of the problems with interpreting overdose death information is that illicit fentanyl and heroin deaths are frequently lumped together with oxycodone- and hydrocodone-related deaths,” said John Burke, President of the International Health Facility Diversion Association and a former drug investigator for the Cincinnati Police Department.

“The vast majority of people prescribed controlled substances take them as directed. Proposed cuts in quotas will negatively impact Americans who have a legitimate medical need for opioids, causing them even more discomfort and distress. These patients are routinely overlooked when considering the prescribing and dispensing of controlled substances, and it is a tragedy.”

Increased Demand for Street Drugs

Other experts warn that further reducing the supply of opioid medication will lead to drug shortages and increase demand for illicit drugs.   

“On the surface, it appears that limiting the quotas…could, in fact, provide a means to address the overdose crisis,” said Marsha Stanton, a pain management nurse, clinical educator and patient advocate. “That, however, will do nothing more than to minimize or eliminate access to those medications for individuals with legitimate prescriptions. We have already seen the effects of back-ordered medications, which create significant barriers to appropriate patient care.”

“Patients who lose access to prescriptions for opioids, have, in some cases, turned to street drugs as an alternative. This has led to increased morbidity and mortality since street drugs have uncertain content and are often used in a comparatively uncontrolled manner,” said Stuart Gitlow, MD, an addiction psychiatrist and past president of the American Society of Addiction Medicine.

“We, therefore, cannot afford to use a crude blunt instrument such as a quota change to address the drug abuse problem. Rather, we must focus on each patient individually and, through education of clinical professionals, ensure that each patient receives medically reasonable treatment.”

By continually insisting on cuts in opioid production, public officials demonstrate a lack of understanding of America’s overdose crisis. Put simply, they’ve failed to do their homework.

“For more than a decade, experts have urged government officials to focus on much more than reducing the opioid-medication supply. Yet, they remain fixated in intellectual laziness,” said Michael Barnes, Chairman of the Center for U.S. Policy and a former presidential appointee in the Office of National Drug Control Policy.

“Policy makers must reduce demand by prioritizing drug abuse prevention, interventions, and treatment. Prevention is the biggest challenge because it will require public officials to realize and respond to the socioeconomic underpinnings of drug abuse. The time is long overdue for politicians to get serious and do the work necessary to save lives and solve this crisis.”   

The disturbing reality is this: Despite rising death tolls and the shortcomings of recent responses, many officials involved in overdose-response policy misunderstand the complexity of America’s overdose crisis.

Until those individuals are educated about the nuances of the issue, they will continue to demand policy that does not adequately address the problem, and the crisis will carry on. Continued ignorance on the part of government officials would truly be, as Mr. Burke put it, a national tragedy.

Christopher Piemonte is a policy manager for the Center for U.S. Policy (CUSP), a non-profit dedicated to enhancing the health, safety and economic opportunity of all Americans. CUSP is currently focused on identifying and advancing solutions to the nation’s substance abuse, mental health and incarceration crises.

‘Opioid of the Future’ Abandoned

By Pat Anson, PNN Editor

A promising new pain medication once touted as the “opioid of the future” because of its low risk of abuse is being abandoned.

Nektar Therapeutics withdrew its new drug application for NKTR-181 (oxycodegol) after two FDA advisory committees voted 27 to 0 against approval of the drug because of lingering concerns about the potential for addiction.

“The Company is disappointed in the Committees' vote regarding oxycodegol and believes it is also disappointing for patients suffering from chronic pain and the physicians that treat those patients who are currently relying on existing opioid therapies,” Nektar said in a statement. “The Company has decided to withdraw the NDA for oxycodegol and to make no further investment into the program.”

The molecular structure of oxycodegol is designed so the drug enters the brain slowly, providing pain relief without the euphoria or “high” that can lead to abuse.

In clinical studies, recreational drug users reported less “drug liking” of oxycodegol compared to oxycodone. Patients with chronic back pain also reported significant pain relief taking the drug twice daily.  

The research was so promising the FDA gave oxycodegol “fast track” designation in 2017 to speed its development.

All that changed, however, when the FDA came under a wave of public and political pressure to tighten its regulation of opioids.  A 60 Minutes report last year claimed the FDA “opened the floodgates” to the opioid crisis by approving the use of OxyContin. The agency also received a petition from Public Citizen calling for a moratorium on new opioid approvals because the agency “can no longer be trusted” due to its “poor record” of regulating opioids.

The FDA advisory committees had concerns about oxycodegol being snorted or injected by drug abusers and its potential for liver toxicity. A staff briefing document also questioned whether Nektar’s clinical studies were adequate.

While the panels’ unanimous recommendation isn’t binding on the FDA, Nektar decided to withdraw its new drug application rather than invest further resources in oxycodegol. That will save the company $75 to $125 million in 2020, according to a news release.

Drug Distributor Stops Opioid Sales

Nektar’s decision came the same day a New York based drug distributor announced it will no longer sell opioid medications. The Rochester Drug Co-Operative (RDC) is the nation’s sixth-largest pharmaceutical wholesaler. It buys medicines directly from drug manufacturers and sells them to 1,300 pharmacies in the Northeast.

"The ever-increasing expenses associated with the legal and regulatory compliance for this segment of drugs are simply not sustainable," RDC said in a statement. "While these specific drugs represent a relatively small percent of total sales, they account for significant legal and compliance expenses." 

Two former RDC executives were charged last year with illegally distributing opioids and conspiring to defraud the government. The company paid a $20 million fine and accepted independent monitoring under a five-year deferred prosecution agreement with the government.

An RDC spokesman said the decision to stop selling opioids was a business decision and not related to the legal case.

Obamacare Prevented Thousands of Opioid Overdose Deaths

By Pat Anson, PNN Editor

The expansion of Medicaid under the Affordable Care Act – widely known as Obamacare -- was associated with a six percent lower rate of opioid overdose deaths, according to a new study that estimates thousands of overdoses may have been prevented by expanding access to healthcare for millions of Americans.

Researchers also found a significant and unexpected increase in overdoses involving methadone, an addiction treatment drug sometimes used to treat chronic pain.

Thirty-two states and the District of Columbia opted to expand Medicaid eligibility under the Affordable Care Act (ACA), providing healthcare coverage to uninsured low-income adults. ACA requires that individuals who receive coverage be provided with mental health and substance use disorder treatment.

Researchers at the NYU Grossman School of Medicine and University of California, Davis looked at death certificate data from 49 states and the District of Columbia between 2001 and 2017— looking for changes in overdose rates in counties that expanded Medicaid under ACA compared to those that did not.

Their findings, published online in JAMA Network Open, suggest that Medicaid expansion prevented between 1,678 and 8,132 opioid overdose deaths from 2015 to 2017.

Overall, there was a 6% lower rate of opioid overdose deaths, an 11% lower rate of heroin overdoses, and a 10% lower rate of death involving fentanyl and synthetic opioids other than methadone in states that adopted the ACA.

"The findings of this study suggest that providing expanded access to health care may be a key policy lever to address the opioid overdose crisis," said senior author Magdalena Cerdá, DrPH, director of the Center for Opioid Epidemiology and Policy in the Department of Population Health at NYU Langone Health.

Methadone Overdoses Rose

Cerdá and her colleagues also found a concerning 11% increase in methadone overdose rates in states that expanded Medicaid under the ACA. Methadone is an opioid that has long been used to treat addiction, but it is also prescribed by some doctors to treat chronic pain.

“Although the rate of methadone-related mortality is relatively low compared with other opioid classes, our finding that Medicaid expansion was associated with increased methadone overdose deaths deserves further investigation,” researchers said.

“Past research has found high rates of methadone use to treat pain among Medicaid beneficiaries and that the drug is disproportionately associated with overdose deaths among individuals in this population, underscoring the importance of ongoing local, state, and federal actions to address safety concerns associated with methadone for pain in tandem with Medicaid expansion.”

In 2014, the methadone prescribing rate among Medicaid patients was nearly twice that of commercially insured patients. Medicaid patients were also slightly more likely to be prescribed methadone for pain (1.1% vs. 0.85%) as opposed to addiction.

Expansion Reduced Opioid Deaths

The ACA became law at a time when opioid overdose deaths were rising sharply. Some critics of Obamacare claimed that expanding access to low-cost opioid pain relievers would create an incentive for low-income Medicaid beneficiaries to sell their drugs.

“It stands to reason that expanding the program — particularly to people most susceptible to abuse — could worsen the problem,” a 2018 report by Sen. Ron Johnson (R-WI) claimed. “The epidemic has indeed spiraled into a national crisis since the Obamacare Medicaid expansion took effect in 2014. Drug overdose deaths have risen rapidly, at a much faster pace than before expansion.”

The NYU and UC Davis study found that theory to be false.

"Past research has found Medicaid expansion is associated with not only large decreases in the number of uninsured Americans, but also considerable increases in access to opioid use disorder treatment and the opioid overdose reversal medication naloxone," said lead author Nicole Kravitz-Wirtz, PhD, an assistant professor in the Department of Emergency Medicine at UC Davis.

"Ours was the first study to investigate the natural follow-up question: Is the expansion associated with reductions in local opioid overdose deaths? On balance, the answer appears to be yes." 

Do Pain Patients Really Get High on Rx Opioids?

By Roger Chriss, PNN Columnist

The standard narrative of the opioid crisis is built on the idea that people feel euphoria or get “high” when exposed to opioids and almost immediately become addicted. Some assert that opioid medications should have no role outside of trauma, surgical, palliative and end-of-life care due to their high risk and side effects.

But reality is more complex.

Euphoria is widely believed to be inevitable with opioids, and increases the risk for misuse and addiction. But in fact, euphoria is not common.

"I think that the notion that opioids [always] cause pleasure is a myth," Siri Leknes, principal investigator at the University of Oslo in Norway, told Live Science.  "I think it's especially important to point out that opioids do not reliably cause pleasure or relief of subjective stress and anxiety in the lab or in stressful clinical settings."

Leknes’ research found that patients receiving remifentanil – a potent, short-acting synthetic opioid -- felt high, but the experience was unpleasant.

"Not everyone experiences the same level of euphoria from opioids, and not everyone that uses opioids will develop an addiction or opioid use disorder,” says Brian Kiluk of Yale School of Medicine.

Major cognitive side effects are often thought to be inevitable with opioids. But a review of 10 clinical studies on older adults with chronic pain found that most “demonstrated no effect of opioid use on cognitive domains.” Only at high daily doses did opioids worsen memory, language and other cognitive skills.

In other words, long-term opioid therapy may cause side effects at doses well above what most people ever receive and beyond thresholds recommended by the CDC and state governments.

The risks of overdose are similarly nuanced. For instance, a study on opioids and mortality looked at a nationally representative sample of over 90,000 people, among whom 14% reported at least one opioid prescription. There were 774 deaths during the study period, with the death rate slightly higher among those taking opioid prescriptions.

However, after adjusting for demographics, health status and utilization, the authors concluded there was “no significant association” between opioids and sudden death. “The relationship between prescription opioid use and mortality risk is more complex than previously reported, meriting further examination," they said.

On the efficacy of opioid therapy, a major review in Germany looked at 15 studies with 3,590 patients with low back, osteoarthritis and neuropathic pain. The quality of evidence was low, but the authors concluded long-term opioid use was appropriate for patients who experience “meaningful pain reduction with at least tolerable adverse events."

Pain Patients Used As ‘Guinea Pigs’

Instead, we have an intense focus on prescribing statistics. States like Minnesota tout a 33% decrease in opioid prescribing for Medicare patients, while ignoring how those poor and disabled people are faring.

“My cat gets better pain management than I do after surgery,” one man wrote to state health officials.

In Ohio, opioid prescriptions have declined by 41% since 2012. Some wonder if the cutbacks went too far.

“There needed to be an adjustment and maybe it did go overboard a bit. I feel bad for the people in chronic pain because they're going to be the guinea pigs for how we get it back to the middle," Ernest Boyd, executive director of the Ohio Pharmacists Association, told the Akron Beacon Journal

So the medical needs of people with cancer, sickle cell disease and other chronic painful conditions are going unmet. And some doctors are even avoiding such patients entirely.

Naturally, there is a need to safeguard the entire opioid supply chain, and to carefully screen and monitor people on any form of opioid therapy. But we also need to track the rapidly evolving policy landscape surrounding prescription opioids to make sure that pain patients with chronic medical needs are being not harmed.

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.

Pain Relief Hard to Find for Sickle Cell Patients

By Sam Whitehead, WABE

India Hardy has lived with pain since she was a toddler — ranging from dull persistent aches to acute flare-ups that interrupt the flow of her normal life.

The pain is from sickle cell disease, a group of genetic conditions that affect about 100,000 people in the U.S., many of them of African or Hispanic descent.

Sitting in the afternoon heat on her mom’s porch in Athens, Georgia, Hardy recollected how a recent “crisis” derailed her normal morning routine.

“It was time for my daughter to get on the bus, and she’s too young to go on her own,” Hardy recalled. “I was in so much pain I couldn’t walk. So, she missed school that day.”

Sickle cell disease affects red blood cells, which travel throughout the body carrying oxygen to tissues. Healthy red blood cells are shaped like plump and flexible doughnuts, but in people with sickle cell disease, the red blood cells are deformed, forming C-shaped “sickles” that are rigid and sticky.

These sickle-shaped cells can cause blockages in the blood vessels, slowing or even stopping normal blood flow. An episode of blockage is known as a sickle cell “crisis” — tissues and organs can be damaged because of lack of oxygen, and the patient experiences severe spells of pain.

‘It’s Like Torture’

Hardy tries to manage these crises on her own. She’ll take a hot bath or apply heating pads to try to increase her blood flow. Hardy also has a variety of pain medications she can take at home.

When she has exhausted those options, she needs more medical help. Hardy would prefer to go to a specialized clinic for sickle cell patients, but the closest is almost two hours away, and she doesn’t have a car.

So, Hardy often goes to the emergency room at nearby St. Mary’s Hospital for relief. Until recently, the doctors there would give her injections of the opioid hydromorphone, which she says would stop her pain.

Then, some months ago, the emergency room changed its process: “Now they will actually put that shot in a bag which is full of fluids, so it’s like you’re getting small drips of pain medicine,” Hardy said. “It’s like torture.”

INDIA HARDY (JOHNATHON KELSO FOR WABE)

It’s the same for her brother, Rico, who also has sickle cell disease and has sought treatment at St. Mary’s. The diluted medicine doesn’t give the same pain relief as a direct injection, they say.

Concerns About Addiction

St. Mary’s staffers explain that they’re trying to strike a balance with their new treatment protocol between adequate pain treatment and the risk that opioid use can lead to drug dependence.

It’s a local change that reflects a national concern. More than 47,000 Americans died in 2017 from an overdose involving an opioid, according to the Centers for Disease Control and Prevention. Most of those deaths involve an illicit opioid such as heroin, but the rising death toll prompted many hospitals to rethink how they administer opioid medications, including how they treat people, such as Hardy, who suffer from episodes of severe pain.

“We have given sickle cell patients a pass [with the notion that] they don’t get addicted — which is completely false,” said Dr. Troy Johnson, who works in the emergency room at St. Mary’s. “For us to not address that addiction is doing them a disservice.”

Johnson proposed the ER’s shift to intravenous “drip delivery” of opioids for chronic pain patients because of personal experience. His son has sickle cell disease, and Johnson said he has seen firsthand how people with the disease are exposed to opioids when very young.

“We start creating people with addiction problems at a very early age in sickle cell disease,” Johnson said.

He brought his concerns to the director of the ER, Dr. Lewis Earnest, and found support for the change. Hospital officials say they also consulted national guidelines for treating sickle cell crises.

“We’re trying to alleviate suffering, but we’re also trying not to create addiction, and so we’re trying to find that balance,” Earnest said. “Some times it’s harder than others.”

St. Mary’s says the new IV-drip protocol is for all patients who come to the emergency room frequently for pain, and most of their sickle cell patients are fine with the change.

Caught in the Crossfire

The national guidelines cited by St. Mary’s also say doctors should reassess patient pain frequently and adjust levels of opioids as needed “until pain is under control per patient report.”

Some people who work closely with sickle cell patients, upon hearing about the new approach to pain management at St. Mary’s, called it “unusual.”

“When individuals living with sickle cell disease go to emergency departments, they are living in extreme amounts of pain,” said Dr. Biree Andemariam, chief medical officer of the Sickle Cell Disease Association of America.

It’s more common for ERs to give those patients direct “pushes” of pain medication via injection, she noted, not slower IV drips.

“If anything, individuals with sickle cell disease in our country have really been caught in the crossfire when it comes to this opioid epidemic.”

— Dr. Biree Andemariam

People with sickle cell disease aren’t fueling the opioid problem, Andemariam said. One study published in 2018 found that opioid use has remained stable among sickle cell patients over time.

“If anything, individuals with sickle cell disease in our country have really been caught in the crossfire when it comes to this opioid epidemic,” Andemariam said.

She suggested that ER doctors and nurses need more education on how to care for people with sickle cell, especially during the painful crisis episodes, which can lead to death.

A study of some 16,000 deaths from 1979 to 2005 related to sickle cell found that men in the group lived to be only 33, on average. Women didn’t fare much better, living to an average age of 37. The same study suggested that a lack of access to quality care is a factor in the short life spans of people with sickle cell disease.

Researchers who study sickle cell say the opioid epidemic has made it harder for patients with the condition to get the pain medication they need. The American College of Emergency Physicians is focusing on the problem, asking federal health officials to speak out about sickle cell pain and fund research on how to treat it without opioids.

“We in the physician community are looking for ways to make sure they get adequate pain relief,” said Dr. Jon Mark Hirshon, vice president of the group. “We recognize that the process is not perfect, but this is what we’re striving for — to make a difference.”

‘They Treat Us Like We’re Not Wanted’

In the meantime, India Hardy said she feels those imperfections in the process every time she suffers a pain crisis, and she’s not alone.

In addition to her brother, Hardy said she has another friend in Athens with sickle cell disease, and that friend has also reported difficulty in finding pain relief at the St. Mary’s emergency room.

“It’s just really frustrating, because you go to the hospital for help — expecting to get equal help, and you don’t,” Hardy said, her voice breaking. “They treat us like we’re not wanted there or that we’re holding their time up or taking up a bed that someone else could be using.”

Hardy filed a complaint with the hospital but said nothing has changed, at least not yet. She still gets pain medication through an IV drip when she goes to the St. Mary’s emergency room.

At this point, she’s considering leaving her relatives and friends behind in Athens to move closer to a sickle cell clinic. She hopes doctors there will do a better job of helping to control her pain.

This story is part of a partnership that includes WABE, NPR and Kaiser Health News, a national health policy news service.

Medical Examiner: ‘I Can’t Remember Last Death From Prescribed Fentanyl’

By Pat Anson, PNN Editor

A recent statement from the San Diego County Medical Examiner’s Office caught our eye – because it offered a rare distinction between prescription fentanyl and counterfeit painkillers made with illicit fentanyl.

It’s an important point for millions of pain patients who use fentanyl responsibly.

“In the last decade when someone overdosed on fentanyl, it was often when someone was prescribed it, and perhaps put on too many fentanyl patches or altered the patches,” said Chief Deputy Medical Examiner Dr. Steven Campman. “I can’t even remember the last time I saw a death from misused prescribed fentanyl.”

Campman was talking about a 68% increase in fentanyl overdose deaths in San Diego. During the first six months of this year, 69 people overdosed on fentanyl -- compared to 41 the year before – and every one of those deaths was attributed to illicit fentanyl.

“Now, in the deaths we see, the fentanyl is illegally obtained as counterfeit oxycodone or alprazolam (Xanax). Illegal drug makers and dealers make pills to look like oxycodone or alprazolam, but the pills have fentanyl in them, and they are deadly,” Campman is quoted in a press release.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine that’s been used for decades in palliative care and as an anesthetic during surgery. More recently, fentanyl has been used in transdermal skin patches, oral sprays and lozenges to treat severe pain.

COUNTERFEIT OXYCODONE

“Each of these new uses of fentanyl exposed millions of Americans to the drug without evidence of an inordinate degree of harm if it was used as directed,” Dr. Lynn Webster explained in a recent column.

Only in recent years has illicit fentanyl become a scourge on the black market and given a bad name to a medication that alleviates a lot of suffering. “Mexican Oxy” and other counterfeit pills made with illicit fentanyl have been linked to thousands of overdose deaths around the country. According to a recent analysis by the DEA, one in every four counterfeit pills have a potentially lethal dose of fentanyl.

“The drug isn’t designed to be put in a pill like that, and it takes very little of it to kill someone. And the illicit drug makers don’t have the kind of quality control measures that pharmaceutical companies have either,” Campman added.

Federal prosecutors have called San Diego the “fentanyl gateway” to the U.S. because the city is near ports of entry in southern California that are major transit points for Mexican drug cartels. In July, a drug courier was pulled over by an alert Texas trooper in Amarillo and found to be transporting 73 pounds of illicit fentanyl powder -- enough to kill 10 million people.

The underground fentanyl trade has also given rise to “Breaking Bad” style pill press operations.

In September, DEA agents found five pounds of pure fentanyl in the San Diego apartment of Gregory Bodemer, a former chemistry instructor at the U.S. Naval Academy, who died from an apparent overdose. Also found in the apartment was a pill press, powders, liquids and dyes used in the manufacture of counterfeit drugs.

Bodemer’s death is yet another example of how the opioid crisis has evolved from a prescription drug problem into a fentanyl crisis.

“This is how we are seeing the opioid epidemic here, mostly in the rise in fentanyl deaths,” Campman said.

FDA Warns of Serious Breathing Problems Caused by Gabapentinoids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning that serious breathing problems can occur in patients who use gabapentin or pregabalin with opioids or other drugs that depress the central nervous system. The elderly and patients with lung problems are at higher risk when they use the drugs, according to an FDA drug safety communication.

The advisory is the latest in a series of warnings about gabapentinoids, a class of nerve medication increasingly prescribed as an alternative to opioid painkillers. There are growing reports of gabapentinoids being abused or raising the risk of overdose and suicide.

“Reports of gabapentinoid abuse alone, and with opioids, have emerged and there are serious consequences of this co-use, including respiratory depression and increased risk of opioid overdose death,” Douglas Throckmorton, MD, deputy director for Regulatory Programs in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“In response to these concerns, we are requiring updates to labeling of gabapentinoids to include new warnings of potential respiratory depressant effects. We are also requiring the drug manufacturers to conduct clinical trials to further evaluate the abuse potential of gabapentinoids, particularly in combination with opioids, with special attention being given to assessing the respiratory depressant effects.”

Gabapentinoid products include gabapentin, which is marketed under the brand name Neurontin, and pregabalin, which is marketed as Lyrica. Generic versions of the drugs are also available.

Gabapentinoids were originally developed to prevent seizures, but their use has tripled over the past 15 years. The drugs are approved to treat a variety of chronic pain conditions, such as fibromyalgia, neuropathy and shingles. They are also widely prescribed off-label.

According to the FDA, over 13 million people filled a prescription for gabapentin in 2016, while over 2 million patients were prescribed pregabalin. Nearly one in five of those patients were also taking opioids.

“Pairing an opioid with any CNS depressant – a gabapentinoid, benzodiazepine, sedating antidepressant, sedating antipsychotic, antihistamine, or other product – will increase the risk of respiratory depression. Shifting treatment from one CNS depressant to another may pose similar risks,” the FDA said.

A Dozen Deaths

The agency said it received 49 case reports of serious breathing problems in patients taking gabapentinoids, including 12 people who died from respiratory depression. It’s advising doctors, caregivers and patients taking gabapentinoids to be alert for signs of confusion, disorientation, dizziness, sleepiness, slow or shallow breathing, unresponsiveness, or bluish-colored lips, fingers and toes.

A 2018 study by Australian researchers found that gabapentinoids often had side effects such as drowsiness, dizziness and nausea. Another study found that combining gabapentin with opioids significantly raises the risk of dying from an overdose. And a recent analysis of calls to U.S. poison control centers found a significant increase in suicide attempts involving gabapentin.

There have also been increasing reports of gabapentin and pregabalin being abused by illicit drug users, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances.

A recent study published in JAMA Internal Medicine found little evidence that gabapentinoids should be used off-label to treat pain and said their effectiveness was often exaggerated by prescribing guidelines. The CDC’s 2016 opioid guideline recommends gabapentin and pregabalin dozens of times as alternatives to opioids, without saying a word about their abuse or side effects.

“Our goal in issuing today’s new safety labeling change requirements is to ensure health care professionals and the public understand the risks associated with gabapentinoids when taken with central nervous system depressants like opioids or by patients with underlying respiratory impairment. However, we do not want to unintentionally increase opioid use by turning prescribers away from this class of pain medications,” Throckmorton said.

Panel Recommends Opioid Guidelines for Acute Pain Conditions

By Pat Anson, PNN Editor 

The National Academies of Sciences, Engineering and Medicine (NASEM) is recommending that new clinical guidelines be developed for the treatment of short-term acute pain to reduce the risk of excess opioid prescribing.  

A 247-page report released by NASEM cites a lack of guidance on the appropriate type, strength and amount of opioid medication that should be prescribed to patients in acute pain, and claims that many patients are sent home with more pills than they need, which can later be misused. 

“Clinicians who prescribe opioids have to balance two distinct goals: relieving a patient’s severe pain, while minimizing the potential public health harms of opioid misuse and the resulting emotional distress to families and communities,” said Bernard Lo, president of the Greenwall Foundation and chair of a NASEM committee that wrote the report.  

The 15-member panel is composed primarily of academic, government and medical professionals. No pain sufferers or patient advocates served on the committee and the report gives no indication they were consulted with.    

NASEM is a private, nonprofit institution that was contracted by the FDA in 2018 to study the treatment of acute pain and develop a framework for new clinical guidelines.

Unlike the CDC’s controversial 2016 opioid guideline, which applies to a broad range of chronic pain conditions, NASEM is recommending that guidelines be developed for specific medical conditions or procedures that result in acute pain lasting less than 90 days. 

High-priority surgical procedures include cesarean (C-section) delivery, total knee replacement and wisdom tooth removal. Acute pain conditions such as low back pain, sickle cell disease, migraines and kidney stones are also considered top priorities for opioid guidelines.  

“There are still too many prescriptions written for opioid analgesics for durations of use longer than are appropriate for the medical need being addressed,” Janet Woodcock MD, Director  of the FDA Center for Drug Evaluation and Research, said in a statement.  

“The FDA’s efforts to address the opioid crisis must focus on encouraging ‘right size’ prescribing of opioid pain medication as well as reducing the number of people unnecessarily exposed to opioids, while ensuring appropriate access to address the medical needs of patients experiencing pain severe enough to warrant treatment with opioids.” 

‘Opioids Commonly Overprescribed’

The CDC guideline was only intended for primary care physicians treating chronic pain, but has been widely implemented throughout the healthcare system by other federal agencies, insurers, states and hospitals. Emergency room physicians are reluctant to prescribe opioids for trauma injuries and some patients recovering from surgery are being treated with Tylenol.    

The NASEM report suggests those efforts haven’t gone far enough. 

“Despite widespread efforts over the last five years to reduce opioid prescribing, opioids are commonly overprescribed for acute pain. In addition, the amount of opioids prescribed for acute pain varies by provider, hospital, and geographical region,” NASEM found. 

The report claims that post-surgical patients consume only half of the opioids prescribed to them, and between 6 percent and 14 percent of patients who receive opioids after surgery or in the emergency room continue to use them six to 12 months later. 

Those claims are at odds with a large Mayo Clinic study found that only about 1% of patients given opioids in emergency rooms went on to long term use. Another large study conducted by Harvard Medical School found less than 1% of patients being treated with opioids for post-surgical pain were later diagnosed with opioid misuse.  

Guidance Gaps

The NASEM report identifies several gaps in current guidelines for acute pain and recommends more research on nonopioid alternatives, outcomes of opioid prescribing on different patient populations, and the amount of opioids prescribed and leftover after treatment. 

As PNN has reported, the CDC is already in the initial stages of updating its 2016 guideline to include recommendations for treating acute pain and how to taper patients safely off opioids. The update likely won’t be completed until late 2021. 

An FDA spokesman described the work of the two agencies as complementary and with similar objectives.   

“We acknowledge the work CDC has taken in developing federal guidelines on pain management and the use of opioids, which are based on expert opinion. Our work seeks to build on that work by generating evidence-based guidelines where needed,” Nathan Arnold said in an email to PNN. 

“The guidelines we generate would be distinct from this corresponding effort by the CDC, in that our effort would be indication-specific, and would be based on prospectively gathered evidence drawn from evaluations of clinical practice and the treatment of pain. Our work could potentially inform drug labelling. These two efforts are highly complementary and serve adjacent goals.” 

One of the co-authors of the CDC guideline is involved in both efforts. Roger Chou, MD, a primary care physician and professor at Oregon Health & Science University School of Medicine, served on the NASEM committee.  Chou is also directing research on three CDC-funded studies on opioid and non-opioid treatments for chronic pain, as well as a fourth study on acute pain treatment. Those studies will be used by CDC to update its current guideline.

Chou recently collaborated with Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group that seeks drastic reductions in the use of opioid medication. Chou co-authored an article with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to taper “every patient receiving long term opioid therapy.”

Health Risks of NSAIDs Led to ‘Significant Under-Treatment of Pain’

By Pat Anson, PNN Editor

The opioid crisis has been blamed on a lot of things, everything from pharmaceutical marketing to poor medical education to an epidemic of despair.

Now we can also blame NSAIDs.

A new study by researchers at Boston University School of Public Health (BUSPH) found that a decline in prescriptions for non-opioid analgesics — mostly non-steroidal anti-inflammatory drugs and COX-2 inhibitors -- coincided with a marked increase in opioid prescribing for people with chronic musculoskeletal pain.

Concerns about the cardiovascular side effects of Vioxx and other COX-2 inhibitors first came to light in the early 2000s. More was also being learned about heart disease, strokes and gastrointestinal problems associated with NSAIDs.

"While the opioid epidemic is complex and has many possible causes, our findings suggest that health risks associated with NSAIDs were one factor that led to increased prescribing of opioids," says lead author Dr. Andrew Stokes, assistant professor of global health at BUSPH.

Stokes and his colleagues looked at 1999-2016 prescription data for over 7,200 U.S. adults with back pain, neck pain or arthritis. Increases in opioid prescriptions matched the decrease in prescribing for non-opioid analgesics (predominantly NSAIDs and COX-2 inhibitors) between 2003 and 2006.

"We realized that the point at which increasing opioid prescriptions crossed over with the decrease in non-opioid prescriptions occurred when the cardiovascular risks of COX-2 inhibitors led to rofecoxib (Vioxx) coming off the market. The gastrointestinal risks of NSAIDs were also well-recognized by then,” says senior author Dr. Tuhina Neogi, a professor of epidemiology at BUSPH and Chief of Rheumatology at Boston Medical Center.

“Thus it appeared to us that an increase in opioid prescribing during that time was, at least in part, an unintended consequence of COX-2 inhibitors coming off the market and concerns about NSAID risk.”

‘Unmet Need for Pain Management’

The study, published in JAMA Network Open, also found that growing recognition of the opioid crisis after 2013 led to decreases in opioid and non-opioid analgesic prescriptions for people with chronic musculoskeletal pain, particularly among those with less education and lower socioeconomic status.

"Care is needed to ensure that our response to the opioid crisis does not leave people living with chronic pain behind. The abrupt decline in prescribing to those of low socioeconomic status is concerning given that these same individuals also face the greatest barriers to accessing alternative pain treatments, such as physical therapy," Stokes says.

"There's so much talk now about transitioning people away from opioids. But if that's happening without considering the barriers to non-pharmacologic treatments, there may be a significant problem of under-treatment of pain," adds study co-author Dielle Lundberg, a research fellow at BUSPH.

Between 2013 and 2106, researchers found an 11% decrease in prescriptions for both opioid and non-opioid pain relievers, suggesting a significant amount of pain was going untreated.

“Care is needed to ensure that our response to the opioid crisis does not leave people living with chronic pain behind.”

— Dr. Andrew Stokes

“The fact that the present study was restricted to patients with potential needs for pain management also raises the concerning possibility that an unmet need for pain management has increased over this period. Such a trend would be alarming given evidence that untreated chronic pain may prompt patients with chronic pain to seek out illicit heroin or fentanyl,” researchers concluded.

“In addition, several recent studies based on data from the National Violent Death Reporting System have found a high rate of chronic pain among suicide decedents, and recent research and commentary on opioid discontinuation have suggested that recent increases in the suicide death rate may be linked to changes in pain treatment.”

U.S. Facing ‘Syndemic’ of Opioid Overdoses

By Pat Anson, PNN Editor

The U.S. opioid crisis is a lot more complex than many people think. Instead of a single “epidemic” fueled by prescription opioids, researchers say there are three types of opioid epidemics occurring in different parts of the country simultaneously.

A team of researchers at Iowa State University studied death certificate data from all 3,079 counties in the lower 48 states and found distinct regional differences in the opioids that caused the most overdoses.

Cities in New England have been hit hard by illicit fentanyl and other synthetic opioids; the Rockies and Midwest are plagued by heroin; and a prescription opioid epidemic still lingers in many rural counties in the South and West.

A fourth epidemic – dubbed a “syndemic” by researchers – involves multiple drugs and exists in counties where the opioid crisis first erupted, particularly in mid-sized cities in Kentucky, Ohio and West Virginia. 

About 25 percent of all U.S. counties fall into one of these epidemic categories.   

“Our results show that it’s more helpful to think of the problem as several epidemics occurring at the same time rather than just one,” said co-author David Peters, PhD, an associate professor of sociology at Iowa State University. “And they occur in different regions of the country, so there’s no single policy response that’s going to address all of these epidemics. There needs to be multiple sets of policies to address these distinct challenges.”

LEADING CAUSE OF OPIOID OVERDOSES

Overdose deaths linked to prescription opioids peaked nationwide in 2013 and have fallen in recent years. But researchers say some counties with poor economies continue to struggle with prescription drugs. Over one-third of the counties in Tennessee, Oklahoma, Nevada and Utah fall into this category.

“We find that prescription-related epidemic counties, whether rural or urban, have been ‘left behind’ the rest of the nation. These communities are less populated and more remote, older and mostly white, have a history of drug abuse, and are former farm and factory communities that have been in decline since the 1990s. Overdoses in these places exemplify the ‘deaths of despair’ narrative,” researchers reported in the journal Rural Sociology.

“By contrast, heroin and opioid syndemic counties tend to be more urban, connected to interstates, ethnically diverse, and in general more economically secure. The urban opioid crisis follows the path of previous drug epidemics, affecting a disadvantaged subpopulation that has been left behind rather than the entire community.” 

The study found heroin overdose deaths clustered along two major corridors, one linking El Paso to Denver and another linking Texas and Chicago. Those findings correspond with known drug routes used by cartels smuggling heroin into the U.S. from Mexico.

The study only looked at death certificate data up to 2016, missing the full impact of the CDC opioid guideline, as well as the widening scope of the fentanyl and counterfeit drug crisis. As PNN has reported, hundreds of people have died on the west coast this year after ingesting counterfeit oxycodone laced with fentanyl.

“We are waiting to obtain the 2017 and 2018 data from CDC, but I expect the number of Rx opioid epidemic counties have transitioned to the synthetic+Rx epidemic and the opioid syndemic,” Peters told PNN in an email. “Fentanyl mixtures are replacing Rx pills and heroin in many places, mainly because fentanyl analogs are cheap to produce and generate more profits for drug traffickers.”

Given the expanding nature of the opioid crisis, Peters and his colleagues say tighter regulation of opioid prescribing and dispensing will have little effect on overdoses. The same is true for law enforcement efforts to stop drug traffickers and smuggling.

Instead they recommend expanding access to addiction treatment, as well as long-term investment in struggling communities to reduce both economic despair and the demand for drugs.  

Severely Injured? Don’t Count on Getting Opioid Pain Medication

By Madora Pennington, PNN Columnist

When I went to Cedars-Sinai Urgent Care in Los Angeles recently, screaming and crying, my blood pressure dangerously high, my foot ballooning and turning blue from a household accident, the doctor wouldn’t give me opioid pain medication.

They x-rayed my foot. Two bones were broken. They gave me a shot of a NSAID that, they said, would wear off in a few hours. It did. They gave me crutches, a boot to immobilize my foot, suggested I see a surgeon and, in the meantime, take Advil. What?

It wasn’t personal. This is Cedars-Sinai’s policy. In urgent care, they won’t give opioids to anyone for any reason.

I had gone to Cedars-Sinai because I have a complex medical history. There, my records are most complete. This makes the appointment easier for the doctor and me.

Also in my records is my long-term opioid use history. I was on Vicodin and morphine daily for about six years, to treat chronic pain from Ehlers-Danlos syndrome, a rare genetic disorder that causes all the joints to be loose, or rather, permanently sprained.

When I started on daily opioids, an option no longer available, I had pain that I could not live with, no quality of life and was planning my suicide.

Those drugs gave me enough relief to endure. I became less of a burden to my caretaker. I could focus on trying to improve my health. If your day is spent fighting extreme pain, being productive is not possible.

Then I got very lucky.

In 2014, experimental treatment had improved the strength of my tendons and ligaments. My body hurt less. I went straight off the opioids and stayed off.

Withdrawal was a harrowing marathon of torture. For years after, I suffered from the physical damage opioids left behind. But I didn’t go back on them because I had never become addicted. Why? I had been warned at the start of my opioid treatment to take the drugs for physical pain only, not for emotional relief. This patient follows orders.

As a result of the war on opioids, many chronic pain patients are being denied adequate pain relief. Some forced to taper end up committing suicide from the agony of withdrawal plus untreated pain. This became such a problem, the U.S. Department of Health and Human Services issued new recommendations in October, advising doctors to look at each case individually and not to put patients on rapid opioid tapers or abruptly discontinue them.

But I had never heard of someone with a severe, acute injury forced to suffer. Even I can’t be trusted? I have a proven record of responsible opioid use with no addiction.

The doctor treating my injured foot, clearly embarrassed, told me, “This is urgent care. If it’s something severe, the patient should be in the ER or at a pain doctor.”

But I had called before I came. “Would they see me for a possibly broken foot?”

The receptionist said to come in, they would x-ray me right away. She didn’t say I would not be given adequate pain medication.

Has the war on opioids gone too far? If doctors and hospitals are too afraid of lawsuits or prosecution to prescribe, then yes.

A Mayo Clinic study found that only about 1% of patients given opioids in emergency rooms went on to long term use. Another study found less than 1% of patients being treated with opioids for post-surgical pain developed dependence or abused opioids. Does that mean the other 99% of us should not get pain medication?

Not according to the CDC, which suggests three days of opioids for acute injuries like mine.

After I left urgent care that day, I took Vicodin which had expired a year before but I’d never gotten rid of. If it hadn’t worked, I would have had to call an ambulance and gone to the ER that night, just for pain treatment.

After surgery, the podiatrist told me, “One bone was in pieces. I bolted together what I could. Some bits were too small so I picked them out and threw them away.” Well, that explains the pain I’d been in.

I vowed never to leave things on the floor that someone might trip on. And I set up Google Home to process a command to make a phone call for help.

I also filed a complaint with the state against the doctor. Medical care is about the patient, not hospital bureaucrats.

Madora Pennington writes about Ehlers-Danlos and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.