DEA Keeping Supply of Rx Opioids Unchanged in 2025

By Pat Anson

The Drug Enforcement Administration says it can’t do anything about shortages of opioid pain medication at U.S. pharmacies and will keep the 2025 opioid supply essentially unchanged from this year’s levels.

Under the Controlled Substances Act (CSA), the DEA sets annual aggregate production quotas (APQs) for every drug maker, in effect telling them the amount of opioids and other controlled substances they can make every year.

The APQs for 2025 were recently published in the Federal Register after a public comment period that received nearly 1,900 responses, many from patients and providers worried about further cuts in the opioid supply.  

“DEA received a significant number of comments from pain advocacy groups, hospital associations, health professionals, and others who raised concerns over the proposed APQs for certain opioids in 2025,” DEA said. “After considering all of the relevant factors, DEA has determined… that U.S. manufacturers will need to manufacture approximately the same amount of those opioids in 2025 as in 2024 in order to meet legitimate needs.”

Although the FDA advised the DEA there will be a 6.6% decline in the medical need for opioids in 2025, the DEA adopted only minor reductions for several widely used opioid medications. They are the same amounts proposed by the agency in October.

DEA Opioid Production Quotas for 2025

• Oxycodone:  0.137% decrease

• Hydrocodone: 0.081% decrease

• Morphine: Unchanged

• Codeine: Unchanged

• Hydromorphone: 0.015% decrease

• Fentanyl: 0.0025% decrease

Although the reductions are tiny compared to previous years, 2025 will still be the ninth consecutive year that DEA has cut the supply of opioids. Since 2015, DEA has reduced production quotas for oxycodone by over 68% and hydrocodone by nearly 73%.

DEA acknowledged receiving many comments from pain patients who said their local pharmacies were often out of opioids, forcing them to contact additional pharmacies and travel further to get their prescriptions filled. DEA said those issues were out of its control.

“Drug shortages may occur due to factors outside of DEA's control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations,” the agency said.  “Currently, FDA has not issued notice of any nationwide shortages of the types of opioid medications mentioned by these commenters.”

The FDA and DEA may not be tracking opioid shortages, but the American Society of Health-System Pharmacists (ASHP) is.

Opioids currently listed in short supply by the ASHP include oxycodone/acetaminophen tablets, oxycodone immediate-release tablets, hydrocodone/acetaminophen tablets, hydromorphone tablets and solution, fentanyl solution, and morphine solution.

Most opioid medications are generic and cheap to make, but they have low profit margins and come with high risks. Teva Pharmaceuticals, a large generic drug maker, recently discontinued production of oxycodone and potent fentanyl lozenges. The medications were entangled in costly litigation that resulted in Teva paying $4.25 billion to settle opioid liability lawsuits.

Opioid shortages at the pharmacy level are also linked to litigation. Under the terms of a 2022 settlement with drug distributors, opioids are tightly rationed at many pharmacies, resulting in patients with opioid prescriptions being unable to get them filled because pharmacies are out of stock.

Here again, the DEA said the shortages are out of its control and claimed its prosecution of doctors for “unlawful” opioid prescribing was a non-issue.

“Patients and medical professionals may notice specific drug products are out of stock in particular areas; however, DEA cannot dictate DEA registrants' distributions of drug products,” the agency said.

“Additionally, DEA's regulations do not impose restrictions on the amount and the type of medication that licensed practitioners can prescribe. DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards.”

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Quotas Don’t Prevent Overdoses

For patients reliant on opioids, including those with late-stage cancer, being unable to fill a prescription means withdrawal, uncontrolled pain, and little quality of life.

A palliative care physician recently wrote an op/ed in STAT about “Teresa,” a patient in her mid-60’s with advanced cancer that spread to her abdomen.

“Only her prescription morphine gave her the relief she needed to function and enjoy some small pleasures, like walking her dog in the park,” wrote Dr. Rebecca Rodin, an assistant professor at the Icahn School of Medicine at Mount Sinai.

“But one day, her pharmacy didn’t have her morphine in stock, nor did five other neighborhood pharmacies that she went to. I called another three pharmacies before finding one with a two-week supply available — but it was a 40-minute drive from her home.”   

Rodin says the real culprits in the overdose crisis are illicit fentanyl and other street drugs – not prescription opioids. And no amount of buck passing by the DEA will fix that problem.

“Quotas and resulting shortages of prescription pain medicines are not helping to prevent overdose deaths,” said Rodin. “Quotas are simply turning vulnerable patients with serious illness into collateral damage in a misguided effort to address the opioid epidemic.”   

After Years of Foot Dragging, CDC Plans Review of Opioid Guideline

By Pat Anson

Eight years after releasing its controversial 2016 opioid guideline and two years after revising it, the CDC is finally making plans for a review of the guideline’s impact on patients, caregivers, doctors, and the practice of pain management.

In a notice published in the Federal Register on Friday, the CDC said it would open a 30-day public comment period on a “mixed-method quasi-experimental approach” to evaluating the updated 2022 guideline.

In plain English, the CDC plans a web-based survey of about 200 clinicians, and individual interviews with 10 clinicians, 2 dentists, 3 health system leaders, 3 insurers, 3 professional association leaders, and 3 medical board leaders. In addition, CDC will interview up to 15 patients and 15 caregivers in focus groups.

The agency did not indicate how the participants or organizations will be selected, or what questions will be asked.

“CDC is comprehensively evaluating the uptake, implementation, and outcomes of the 2022 CDC Clinical Practice Guideline on evidence-based care for pain management to understand its impact,” the agency said. “The evaluation includes dissemination and impact of the 2022 CDC Clinical Practice Guideline through population-wide changes in prescribing practices for opioids and medications for opioid use disorder.”

This is actually the second time CDC has published a public notice about the guideline review. Only two public comments were received after a similar notice was published in the Federal Register on October 1, which the CDC made no effort to publicize.

‘Timing Is Very Odd’

It’s not clear why a second notice was published during the holiday season and in the final weeks of the Biden administration. CDC did not immediately respond to a request for comment.

“The timing is very odd, and almost everyone missed the opportunity for open comments earlier this year,” said Chad Kollas, MD, a palliative care physician and pain policy expert.

“Few states have backed off from overly restrictive prescribing laws that were created based on the 2016 Guideline. I think that’s the main opportunity here, documenting the failure to implement the revised recommendations in the 2022 guidance. It’s unclear how CDC plans to determine who will get an opportunity to respond in the proposed study, so transparency remains troublesome for them.”

The CDC was slow to acknowledge the harm caused by the 2016 guideline. Although voluntary, the agency’s recommendations were widely implemented as mandatory by states and law enforcement agencies, resulting in patients having their opioid medication reduced or cutoff, and doctors being prosecuted for exceeding the guideline’s dosage recommendations.

To address those issues, CDC issued a revised guideline in 2022. But many of the problems caused by the original guideline linger.

“The 2016 guidelines led to a variety of restrictive policies, including limitations on opioid dosages. These measures created significant barriers for patients trying to access pain care and made it more challenging for physicians to prescribe necessary medications,” Donald Arnold, MD, President of the American Society of Anesthesiologists (ASA) wrote in a letter to the CDC, one of the two public comments made in response to the October 1 public notice.

The ASA surveyed its members on the impact of the 2022 revised guideline. Over half (56%) thought it was “somewhat effective” in reversing the harm caused by the 2016 guideline, while 40% thought it was ineffective.

A PNN survey of over 2,500 patients, providers and caregivers also found mixed reviews of the 2022 guideline. Only 39% of respondents thought it was “improved” or “much improved” over the original guideline.  Most respondents said it was about the same or even worse.

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‘Same Problems Still Exist’

The CDC never conducted a comprehensive review on the impact of the 2016 guideline, but it did hire a consulting firm to improve its image after the agency was widely criticized for its secrecy and lack of transparency during the guideline’s development process.

A former CDC epidemiologist was so dismayed by the agency’s lack of accountability that he wrote a book about it, “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids.” Dr. Charles LeBaron says CDC leadership was blinded by its own hubris.

“The problem was not looking at the (guideline) sufficiently quantitatively and then not checking the consequences, or at least responding to the consequences when they're brought to your attention,” LeBaron told PNN. “Many of the same problems continue to exist, even though the personalities are completely different, and there are still significant restrictions on people in chronic pain for no apparent benefit.”

The personalities will change yet again when the Trump administration takes office on January 20. Conservative activists have made clear they want a major restructuring of the CDC, returning the agency to its core mission of collecting and disseminating data on communicable diseases. They want the CDC to stop telling people what to do, and to leave medical guidelines to professional societies and state medical boards.

Unlike other public notices in the Federal Register, the CDC is not making it easy for people to comment online. Comments can be left at a confusing public portal or be sent in written form to this address:

CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503

People can request further information on the guideline review and obtain a copy of the information collection plan by calling (404) 639-7570.

CVS Pushes Back Against DOJ’s Latest Opioid Lawsuit

By Crystal Lindell

The U.S. Justice Department’s latest opioid lawsuit against CVS is getting some push back from the pharmacy chain. The DOJ alleges that CVS knowingly filled “unlawful prescriptions” for opioids and other controlled substances, and then sought reimbursement for them from federal healthcare programs like Medicaid and Medicare.

Specifically, the DOJ claims that CVS had “corporate-mandated performance metrics” that incentivized pharmacists to fill the prescriptions. The government also alleges that CVS “set staffing levels far too low” for pharmacists to meet their corporate goals and legal obligations.

“Our complaint alleges that CVS repeatedly filled controlled substance prescriptions that were unlawful and pressured its pharmacists to fill such prescriptions without taking the time needed to confirm their validity,” Deputy Assistant Attorney General Brian Boynton said in a statement. “The practices alleged contributed to the opioid crisis and opioid-related deaths.”

CVS issued a statement in response to the lawsuit that “strongly disagrees with the allegations and false narrative.” The company said the standards the DOJ is claiming CVS didn’t meet are so vague and ever-changing as to be useless. 

“The government’s lawsuit seeks to impose a shifting standard for pharmacy practice,” CVS said. “Many of the litigation theories laid out in the complaint are not found in any statute or regulation, and relate to topics on which the government has declined to provide guidance.

“Each of the prescriptions in question was for an FDA-approved opioid medication prescribed by a practitioner who the government itself licensed, authorized, and empowered to write controlled-substance prescriptions.”

I have to say, it’s good to see CVS defend itself in these situations. 

Especially by pointing out the obvious: The prescriptions were written by doctors who were licensed by the government. Although pharmacists have a “corresponding authority” to make sure a prescription is legitimate, why should a private pharmacy chain be held to a higher standard than the government itself?

The government’s lawsuit intensifies a serious dilemma for the pharmacy industry, which is simultaneously second-guessed for dispensing too many opioids and for filling too few. 

Over the last few years, it seems like every government agency in existence has been looking for anyone they could possibly sue in relation to opioids. As a result, about $50 billion in opioid settlement money will be paid in coming years by opioid makers, distributors and pharmacies.

However, there’s one glaring aspect of this tactic that makes it clear the lawsuits aren’t about helping people hurt by opioids, but about finding ways for the government and plaintiff law firms to get more money. Much of the settlement money received so far has been earmarked for law enforcement and other government projects that have little to do with opioids.

‘We Will Defend Ourselves’

CVS has already agreed to pay about $5 billion to settle opioid litigation. The company says the latest lawsuit, which seeks unspecified additional penalties, is just another cash grab.

“We will defend ourselves vigorously against this misguided federal lawsuit, which follows on the heels of years of litigation over these issues by state and local governments — claims that already have been largely resolved by a global agreement with the participating state Attorneys General,” the company said. 

CVS says it has been an “industry leader” in developing programs to fight opioid misuse. In recent years, the nation’s largest pharmacy chain has refused to fill controlled substance prescriptions written by over 1,250 doctors, about half of whom the government continues to license. 

The company also points to its “Our Opioid Response” website, which features a telling headline about government regulations and the scrutiny faced by pharmacists: 

“Fill this opioid prescription. No, wait, actually you can’t do that. Or, maybe, you can: The dilemma for community pharmacists.”

The text on the site then goes on to again point out the DEA’s vague guidance and inconsistent stance on the issue. 

“Whichever decision they make, community pharmacists know they can – and will – be second-guessed later. Too often, we have seen government agencies and trial lawyers question the good-faith decisions made by pharmacists while a patient waits at the pharmacy counter, often in pain. While simultaneously being accused of dispensing too few opioids and too many, pharmacists and pharmacies face threats of liability no matter their actions,” CVS said.

A recent court case suggests that CVS and other pharmacy chains are making some headway in defending themselves. The Ohio Supreme Court ruled this week that CVS, Walmart and Walgreens are not “public nuisances” under the state’s product liability law. Similar rulings have also been made in West Virginia, California and Oklahoma, rejecting public nuisance claims that resulted in costly opioid settlements.

CVS says it is standing up for “patients enduring relentless pain,” and as a patient who faces relentless pain, I’m happy to see it. While I’m skeptical that the overall tide is turning when it comes to public attitudes about opioids, it’s good to know at least one company is pushing back. 

12 Holiday Gifts for People with Chronic Pain and Illness

By Pat Anson

Are doctors and pharmacists helping the DEA spy on pain patients? Does Big Pharma control how healthcare news is reported? Is the Epstein-Barr Virus the hidden cause of your chronic pain? Can kratom be used safely? Are you buzzed that Willie Nelson wrote a cannabis cookbook?

The answers to these and other questions can be found in PNN’s annual holiday gift guide. If you live with chronic pain and illness or have a friend or family member who does, here are 12 books that would make great gifts over the holidays. Or you can always “gift” one to yourself. Click on the book cover or title to see price and ordering information.

The Epstein-Barr Virus: A New Factor in the Care of Chronic Pain

Dr. Forest Tennant examines the Epstein-Barr Virus (EBV) and its hidden role in causing chronic pain. We are all carriers of EBV, which is normally harmless and dormant. But when the virus reactivates, it is carried throughout the body, infecting and damaging body tissues. Dr. Tennant says anyone with chronic pain severe enough to require daily pain medication may have EBV reactivation, and should take steps to diagnose and treat it. 

Policing Patients: Treatment and Surveillance of the Opioid Crisis

Prescription Drug Monitoring Programs (PDMPs) were launched across the country to help prevent drug abuse and save lives. In actuality, author Elizabeth Chiarello says PDMPs are “Trojan horse” surveillance tools used by law enforcement to spy on patients. PDMPs interfere with the practice of medicine by turning doctors and pharmacists into undercover agents — often pitting them against their own patients.

Greed to Do Good: The CDC’s Disastrous War on Opioids

Dr. Charles LeBaron worked for nearly three decades as an epidemiologist for the Centers for Disease Control and Prevention. Although not directly involved in the CDC’s opioid prescribing guideline, LeBaron recognized the disastrous consequences it had on patients. In this book, he gives an insider’s perspective on the CDC’s institutionalized arrogance and how its misguided strategy to reduce overdoses only made the opioid crisis worse.

Follow the Science: How Big Pharma Misleads, Obscures, and Prevails

Journalist Sharyl Attkisson exposes how the pharmaceutical industry infiltrated government and academia, enabling it to put profits over people by controlling how healthcare is covered by the news media. “We exist largely in an artificial reality brought to you by the makers of the latest pill or injection,” Attkisson writes. “Invisible forces work daily to hype fears about certain illnesses, and exaggerate the supposed benefits of treatments and cures.”

Lies I Taught in Medical School

Inspired by his own health problems, Dr. Robert Lufkin wrote this book to expose the “medical lies” that contribute to chronic illness — some of which he taught as a professor at UCLA and USC. Lufkin believes pills and procedures are prescribed too often to mask symptoms, when diet and lifestyle changes can resolve many chronic conditions like diabetes, hypertension, obesity, and cardiovascular disease.

The Big Book of Kratom: The Ultimate Manual to Understanding and Using Kratom

Author Fallon J. Smith takes a deep dive into the pros and cons of kratom, gleaned from many years of using it himself. New kratom users can learn about the various strains and methods of ingesting the herbal supplement to treat everything from chronic pain and anxiety to addiction and depression. Smith also shares important lessons about dosing, side effects, and the potential risks of kratom withdrawal and addiction.

Willie & Annie Nelson’s Cannabis Cookbook

Legendary singer/songwriter Willie Nelson and his wife Annie share their favorite recipes for getting high and full at the same time. Part travelogue and part cannabis cookbook, there’s a colorful story behind every recipe, such as Baked Eggs & Asparagus (with 17mg of THC), Vegan Cannabis Butter, Cannabis Chocolate Cake, and Buttermilk Fried Chicken (no THC).

On Call: A Doctor’s Journey in Public Service

In this memoir, Dr. Anthony Fauci shares some of the highlights — and lowlights — from nearly 40 years working for the National Institutes of Health, including the crucial roles he played in fighting AIDS, the Ebola virus, SARS, anthrax and, of course, Covid-19. Fauci grew up in modest circumstances, living above his father’s Brooklyn pharmacy, to become a health advisor to seven presidents and one of the most famous doctors in world.

Grown Woman Talk: Your Guide to Getting and Staying Healthy

Dr. Sharon Malone is an OB/GYN who wrote this book to help older women deal with the complexities of aging. Often ignored or gaslighted by the healthcare system, older women may have their chronic pain and discomfort dismissed as female hysteria caused by menopause. Dr. Malone has tips to end this “normalized suffering” and empower grown women to live better, age better, and get better medical treatment.

Long Illness: A Practical Guide to Surviving, Healing and Thriving

Drs. Meghan Jobson and Juliet Morgan wrote this book to give patients and providers a better understanding of long-lasting illnesses such as autoimmune disease, chronic fatigue, chronic pain, inflammation and Long Covid. They take a holistic approach to managing symptoms through cognitive behavioral therapy, traditional Eastern medicine, mindfulness and self-care — emphasizing that recovery is a process and not always a destination.

Toxic Stress: How Stress Is Making Us Ill

Dr. Lawson Wulsin is a psychiatrist who has found that toxic stress and childhood trauma often play hidden roles in the development of heart disease, diabetes, depression and chronic illnesses in midlife. In this book, Dr. Wulsin offers practical advice and tools to recognize signs of toxic stress in our lives, and learn how to help your mind and body recover from it.

The Long Covid Reader

Author Mary Ladd shares the stories of 45 people living with Long Covid, who recount in essays and poems how COVID-19 continues to impact their lives long after their initial infections. A long-hauler herself, Ladd spent a year gathering personal stories about Long Covid in an effort to humanize the neglected suffering of millions of people who live with a mysterious chronic illness from the “world's biggest mass-disabling event.”

These and other books about living with chronic pain and illness can be found in PNN’s Suggested Reading page.  PNN receives a small amount of the proceeds -- at no additional cost to you -- for orders placed through Amazon.

Low Dose Opioids Do Not Raise Dementia Risk, But High Doses Might

By Crystal Lindell

There’s a new study out showing that low-dose opioids are not linked to an increased risk of developing dementia, but higher doses might. 

Researchers followed the health of over 1.8 million people in Denmark aged 60 to 75, about 5% of whom developed dementia. They tracked the opioid use of those with and without dementia to see what role, if any, opioids may have in causing cognitive decline.

They found that low dose opioids prescribed for chronic non-cancer pain — which they defined as up to 90 total standardized doses (TSDs) — was not consistently associated with dementia risk. However, doses above 90 TSD were associated with a slightly elevated dementia risk before age 90. 

Interestingly, the strongest association between opioids and dementia was found with “weak” opioids such as tramadol.

Total standardized doses are a different way of measuring opioid use than what is typically used in the United States. Medical guidelines in the U.S. focus on morphine milligram equivalents (MME) per day. Depending on the guideline, anything over 50 or 90 MME would be considered a high dose.   

For the Danish study, 1 TSD is the equivalent of 30 MME. So someone with a TSD of 90 is getting the equivalent of 2,700 MME over time. Researchers used this method because they wanted to see what the cumulative effect of opioids would have on dementia.  

“This study found that opioid use of less than 90 TSDs was not significantly associated with increased dementia risk. Above 90 TSDs of opioid use was associated with an elevated dementia risk before age 90 years, which persisted in individuals with chronic noncancer pain and in individuals solely exposed to weak opioids,” researchers reported in JAMA Network Open,.

They also added the favorite caveat of medical researchers everywhere: “Further research should ascertain whether the findings denote causality between opioids and dementia risk.” 

In other words, it is still unclear if taking higher doses of opioids leads to dementia, or if chronic pain puts people at higher risk of dementia. It’s a chicken and egg question without any answers. 

A previous study also found that high doses of opioids slightly raise the risk of dementia, but so did nonsteroidal anti-inflammatory drugs (NSAIDs). So switching someone from opioids to NSAID pain relievers won’t lower their risk.  

Regardless, given the findings in the Danish study about the lower doses, I am glad to see some more definitive evidence that opioids aren’t the cause of every ailment ever. 

I do worry that the study even existing will perpetuate harmful opioid-phobia myths though. For example, the study’s headline – “Opioids and Dementia in the Danish Population” – is just vague enough that casual readers may assume that the research did show a link between opioids and dementia, regardless of the dose. 

It also irks me that researchers included the favorite sentence of opioid-phobia propagandists: "Opioids are frequently used to treat chronic noncancer pain, but evidence of the effect on pain management and quality of life is lacking." 

As usual, the fact that millions of people around the world have told doctors that opioids help their pain is apparently not “evidence.” They can’t trust any of us.  

As someone who’s been on what the researchers would consider “low dose” opioids since I was 29 years old, I can tell you they do help manage my pain and give me a better quality of life. If the researchers found a higher dementia risk for me, I’d still keep taking opioids. 

Opioids are the only thing that allows me to live my life today. I’m not going to give that up because I might have a higher risk of dementia decades from now. In fact, if I did give them up, I suspect there’s a high chance that I would not make it into my senior years anyway, seeing as how opioids are often the only thing that makes my daily pain endurable. 

I suspect I’m not alone. Research like this is unlikely to deter most pain patients from taking opioids, but it could make some doctors hesitant to prescribe them. And that’s a shame. Because a study showing that low-dose opioids aren’t as bad as some feared should make doctors more comfortable prescribing them.

ER Opioids ‘Extremely Unlikely’ to Lead to Addiction

By Pat Anson

Many patients in pain have horror stories to share about their experiences in hospital emergency rooms, where they’ve been treated as drug seekers and denied opioid medication.

“I had a broken arm and was given nothing for pain when leaving the emergency room,” one patient told us. “They now treat everyone like a drug seeking addict even if you have legitimate pain!”

“My last ER visit has caused me PTSD. It was awful they put me in a room and turned the light off and left me there for hours,” said another.

“The emergency rooms are horrible,” said a patient with a fractured rib. “I wasn’t even asking the ER for meds. I wanted an x-ray or something because I was in excruciating pain.”

Are fears about opioid addiction justified? A new study found that the risk of developing opioid use disorder after being treated with intravenous opioids in the ER is quite low – less than one-tenth of one percent (0.002%).

Out of 506 patients treated with IV opioids in two Bronx emergency rooms, only one met the criteria for long-term or persistent opioid use six months later.

“These data suggest that the use of IV opioids for acute pain among opioid-naive patients is extremely unlikely to result in persistent opioid use,” wrote lead author Eddie Irizarry, MD, an emergency medicine physician at Montefiore Medical Center.

“Opioid naïve” means the patients had never taken opioids before or only used the drugs infrequently.

The study, recently published in The Journal of Emergency Medicine, defines persistent use as filling six or more opioid prescriptions in the 6 months after an ER visit, or an average of one prescription per month.

The most frequently reported IV opioid administered in the ER was morphine (94%), followed by hydromorphone (4%) or a combination of both morphine and hydromorphone (2%). The researchers noted that most of the morphine doses were “relatively modest.”

After being treated in the ER, 63 of the patients (12%) received an opioid prescription on discharge.   

The researchers cautioned that opioids should be used “judiciously” and that many ER patients could be treated with non-opioid analgesics such as acetaminophen. But they could find no evidence that IV opioids should be routinely denied in the ER.

“We are not aware of compelling data to support denying parenteral opioids to opioid-naïve patients who are suffering from severe acute pain,” said Irizarry.   

The research mirrors the findings from a 2017 Mayo Clinic study, which found that the risk of long-term opioid use is lower for ER patients than it is for patients treated in other medical settings. In the Mayo study, 1.1% of opioid naive patients became long term users. That compares to 2% of patients who were prescribed opioids in non-emergency settings.

The Stress of Navigating Opioid Shortages As a Patient

By Crystal Lindell

At 9:30 am Monday morning, I got one of the most dreaded phone calls that someone taking a controlled substance can get – my pharmacy was completely out of my pain medication, Morphine Sul ER. 

Chronic shortages of prescription opioids were finally impacting me directly. 

At first, the pharmacist tried to make it sound like there was just a small delay, asking me, “How how many pills you have left?”

None. I had none left. Because pain medication refills usually aren’t filled until you completely run out. There’s not even a one-day leeway built in, because god forbid pain patients have one extra pill ever. 

Even if I did have some left, I couldn’t tell the pharmacist that, because it might risk having that used against me later. Afterall, if I had extras, that shows that I don’t need to be prescribed as many pills as I was getting. 

You’re always risking something as a pain patient. If you try to plan too far ahead by stockpiling extra pills, they could use that to reduce what you’re prescribed. And if you don’t plan ahead at all, you risk physical pain and withdrawal if there are any issues getting your refill – issues beyond your control like a drug shortage. 

As it turned out, it wouldn’t have mattered if I did have some pills leftover because the situation was worse than the pharmacist was initially letting on. This wasn’t an issue of waiting for an afternoon shipment or even a next-day restock. The pharmacist didn’t know when my medication would be back in stock at all. 

She said she had been requesting more pain medication every day, but their supplier wasn’t providing any updates on a timeline for when that would happen. So she suggested that I call around to other pharmacies to see if any of them had it in stock. 

There’s just one problem: the pain contract I had to sign to get a monthly opioid prescription technically bans me from getting refills at different pharmacies. I don’t think there are any exceptions in the contract. And if I break it, I risk losing access to the only medication that makes it possible for me to function on a daily basis. 

So even if I could find another pharmacy, I wasn’t sure if my doctor would let me get the medication filled there. 

The pharmacist was surprisingly understanding of this, and said that she had already called my doctor before calling me, so she was hopeful that they would be accommodating. 

At that point I realized that any plans I had for my Monday morning were now canceled, because I was going to have to spend the next few hours trying to navigate this. 

I made one last attempt to get the situation resolved without having to loop in another pharmacy, asking if they had an alternative medication that wasn’t too expensive because I don’t have health insurance. My medication is an extended release opioid, and the pharmacists said all they really had was the instant-release versions – which I knew my doctor would not want to swap in.

So, another pharmacy it would have to be. 

I did wonder for a moment if my pharmacy was lying to me about being out of stock. It was just last month that I had to negotiate the price of this same medication with them after they tried to increase the price by $50. 

Maybe they just didn’t want to deal with me, a long-term opioid patient, any more. So after the attempted price increase failed to deter me, they were trying a different tactic. 

The thing is, how would I even find that out? As far as I know, there’s no accountability for pharmacies that lie to patients about why they aren’t able to fill a prescription. Most people understand why that’s concerning when it comes to things like birth control or insulin, but when it’s pain medication, the general public tends to side with the pharmacist who doesn’t want to fill the prescription. 

At that point, I started calling other pharmacies. Thankfully, a locally owned one said they had the medication in stock and that they could fill it. I called my doctor to see if they’d transfer the prescription, and his receptionist took down the message. Then, I waited. 

I spent the next few hours anxious about whether this would all work out, and how long it would be until I got my refill. Finally, at about 1 pm, I saw in MyChart that the medication had been sent to the new pharmacy. 

Then I called the new pharmacy to make sure they saw my prescription come through and to ask what the cash price was. It was going to be $52, about $16 more than I paid at the other pharmacy. I probably could have asked them about using a GoodRx coupon, but I was already throwing a controlled substance prescription on them at the last minute, and they had it in stock, so I didn’t want to make waves. 

A few hours later it was finally filled, sort of. At 3 pm I arrived at the pharmacy to pick it up, after driving 25 minutes on rural roads to get there. 

They handed me the bottle and said, “Oh, by the way, we’re two pills short. Hopefully we will have those in for you later this week. So you can come back and pick them up then.”

Another 50 minutes of round-trip driving was suddenly in my future. 

I’m thankful that I found a pharmacy with any of my medication in stock, and I’m happy that my doctor seemed to handle the prescription transfer without issue. 

What Happens Next Month?

But the entire, stressful ordeal wiped out most of my day, and now I also have to figure out what will happen next month. 

Will the shortage impacting my medication be handled by then? Or should I try to have my doctor switch my prescription to something else? And if he did that, how much would that medication cost? Should I have my prescriptions permanently transferred to the other pharmacy? Is the one I normally go to going to give me a hassle every month now?

If medication shortages don’t impact you directly, it can be easy to gloss over reports like the one from the American Society of Health-System Pharmacists (ASHP), which found that shortages of drugs used for pain, anesthesia, chemotherapy and attention-deficit/hyperactivity disorder (ADHD) “continue to be problematic.” 

Those shortages impact real people. Despite a stressful morning, I was among the lucky ones, as I was able to get it worked out within just one day. Who knows if that will be the case next month though. 

The ASHP cited reduced DEA production quotas and the fallout from opioid litigation as some of the reasons for the drug shortages, which have led to rationing at many pharmacies. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy.

We need the government to start working on behalf of patients to get this resolved. I can’t just call up the manufacturer of Morphine Sul ER and tell them to make more. It has to be the government that intervenes. 

The best place to start would be to lift the DEA production quotas – although that’s really just a start. If we’re being realistic here, there should also be production minimums, with government funding and support if needed. 

People’s lives depend on these medications. It’s time to stop pretending that these drug shortages are just trivial inconveniences. They’re harmful, and sometimes even deadly.

Where Did the Opioid Settlement Money Go?

By Crystal Lindell

How are states spending their opioid settlement money? Unsurprisingly, it’s often hard to say – even when a state has promised transparency. 

Federal, state and local governments in the United States will collect about $50 billion in opioid settlement money in coming years from basically every sector of the health care industry, including drug makers, wholesale distributors and pharmacies. 

But an investigation of 12 states by NPR and KFF Health News found that it’s unclear how much of that money is being used to prevent addiction or to help people with substance abuse issues. 

As a pain patient, I have long assumed that none of the settlement money would be used to develop effective, non-opioid pain analgesics for patients who lost their medication as a result of opioid-phobia. Based on how everything around opioids has played out over the years, I also didn’t have high hopes for what it would actually get spent on.

The NPR/KFF Health News investigation shows that I was correct to worry. 

“There are no national requirements for jurisdictions to report money spent on opioid remediation,” Aneri Pattani reported.”In states that have not enacted stricter requirements on their own, the public is left in the dark or forced to rely on ad hoc efforts by advocates and journalists to fill the gap.”

Pattani shared a story about the situation in Idaho, where local governments were required to complete a form showing how they spent settlement money and whether it was for an approved purpose. But a process meant to show transparency seemed to do just the opposite. 

“In reality, it reads like this,”said Pattani. “In fiscal year 2023, the city of Chubbuck spent about $39,000 on Section G, Subsection 9. Public Health District No. 6 spent more than $26,000 on Section B, Subsection 2. Cracking that code requires a separate document. And even that provides only broad outlines.”

Pattani said that following the money trail just led to more intentionally confusing bureaucratic language. 

For example, she found that Subsection 9 refers to “school-based or youth-focused programs or strategies that have demonstrated effectiveness in preventing drug misuse.” 

Subsection 2 refers to “the full continuum of care of treatment and recovery services for OUD and any co-occurring SUD/MH conditions.” 

“What does that mean? How exactly are you doing that?” Corey Davis, a project director at the Network for Public Health Law, wondered when he first saw the Idaho reports. Without detailed descriptions of the projects the money was spent on, it’s impossible to track. 

“It’d be similar to saying 20% of your monthly salary goes to food,” Pattani wrote. “But does that mean grocery bills, eating out at restaurants, or hiring a cook?” 

Minnesota’s ‘Dashboard’

Some states are more transparent about where the money is going. Minnesota, for example, has an online dashboard and downloadable spreadsheet listing projects. One project was in Renville County, which used $100,000 to install a body scanner in its jail to help staff find drugs in the body cavities of inmates.

So, cops are getting the money. And when you look around on the Minnesota dashboard, it becomes clear that law enforcement agencies got some of the largest shares of the state’s opioid settlement money.  

So far, Minnesota has received over $74 million in settlement money. Of that, law enforcement-related categories received about $17 million, coming in fourth behind "American Indian" with $32.6 million, “African or African American" with $22.6 million, and "Child protection” which received $22.65 million. 

I was pleasantly surprised to see that Minnesota does have a "Chronic pain patients" category — but then was disappointed to learn that it got the least amount of money of any group, receiving just $290,180 of the state’s settlement funds.

When I drilled down deeper on the chronic pain category, things only got more depressing. 

The bulk of that money ($257,220) went to Hennepin Health System to "expand access to holistic chronic pain treatment through Heals on Wheels program,” which includes traveling clinics that provide training in mindfulness, stress management, mindful movement, acupressure, acupuncture and massage therapy.

The remaining $32,960 went to a group called Health Partners, which said it would use the money to, "Certify 10 clinicians to provide Empowered Relief, a one-session class that equips patients with pain management skills, draws on principals from mindfulness and cognitive behavior therapy.” 

As a pain patient, finding out that the very small amount of Minnesota’s opioid money going to pain patients is being used to fund BS about mindfulness is beyond infuriating. We need real treatments, not happy thoughts.

Of course, in other states, it’s hard to even know how much money is going to cops and if any is going to chronic pain patients, so I guess I should be happy that there’s at least some record of things in Minnesota.  

Interestingly, over $1.9 million of Minnesota’s settlement money went to the Steve Rummler Hope Foundation, primarily for opioid education and naloxone distribution. 

Coincidentally, the Rummler Foundation happens to be the fiscal sponsor of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played an instrumental role in raising fears about opioid use and addiction.

Several PROP members worked as paid expert witnesses for plaintiff law firms that pursued opioid litigation on behalf of the states, and were paid as much as $850 an hour for their services. The law firms themselves will pocket billions of dollars in contingency fees once all the funds are paid. That kind of detail is rarely mentioned in reporting on how settlement money is used.   

So while some details of how opioid funds were spent are technically available to the public, Pattani says it doesn’t matter if finding them requires hours of research and wading through budgetary jargon.

“Not exactly a system friendly to the average person,” she said.

Of course, if any of the opioid settlement money was ever actually meant to help people who may have been harmed by opioids, it wouldn’t be going to governments – it would be going directly to opioid users or their surviving loved ones.

But it’s been clear from the beginning that these opioid settlements were primarily a cash grab for state and local governments, plaintiff law firms, and their expert witnesses. They don’t help patients and they don’t help their loved ones. 

I don’t expect any of the states to increase transparency about where the money has been going. Most of the general public doesn’t care, so the states can funnel a lot of the money into things like body scanners, because they don’t have the pesky public watching what they’re doing. 

Maybe next time when we decide to sue every pharmaceutical company and pharmacy chain in the country, we could at least make it class action lawsuits on behalf of patients, not governments.

Return to Sender: WIll Anyone Use FDA’s New Opioid Mail-Back Program?

By Crystal Lindell

The DEA has been hosting drug “Take Back Days” for over a decade, collecting over 9,200 tons of unwanted or expired prescriptions and over-the-counter medicines. The take-back program is seen as a key effort to prevent drug diversion and opioid addiction.

Now the Food and Drug Administration is expanding its own drug collection program – essentially making every day an opioid take-back day.  

Starting on March 31, 2025, drug makers participating in the FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)  – which means every company that makes and sells opioids – will be required to provide pre-paid, drug mail-back envelopes “upon request” to pharmacies that dispense opioids. The pharmacies then have to give the envelopes to patients and caregivers who ask for them, so they can mail back any unwanted opioids. 

The fact that both pharmacies and patients have to request these envelopes makes me skeptical about how much this program will actually be used.

The press release from the FDA includes a quote that sounds surprisingly pro-patient though. So even if the program doesn’t have a high use-rate, perhaps an extra measure of safety will make it easier for patients to get opioid prescriptions. 

“We want to ensure patients have access to opioid analgesics in their pain management regimens and that they are educated about methods available to safely dispose of any leftover medicines, which could pose a real danger to their loved ones and pets,” said Marta Sokolowska, PhD, deputy center director for Substance Use and Behavioral Health at the FDA Center for Drug Evaluation and Research.  

It’s the part about ensuring that “patients have access to opioid analgesics” that stands out to me. Patients certainly need access to opioid pain meds. And if programs like this help doctors and medical professionals feel more comfortable prescribing opioids, then I fully support them. 

But I’m skeptical about whether that will be the actual outcome. The real question is whether anyone will use the mail-back program. 

The DEA has never released a full breakdown of the medications returned during its drug take-back days. But an analysis of the drugs returned at a take-back day in Lansing, Michigan in 2013 provides some insight. 

Of the nearly 2,500 medication containers that were returned, only 304 were for a controlled substance like opioids – about 12% overall. The most common types of medication returned were for pain/spasm, cardiovascular, and mental health conditions.

While hydrocodone/acetaminophen combinations (Norco) were the most returned medication at that 2013 event, it represented just 4.4% of all returned containers. 

The second most-common drug returned was ibuprofen (Advil) in 2.2% of the containers. Acetaminophen (1.7%) and aspirin (1.3%) also made the top ten list of most-returned medications. 

Something tells me that Advil isn’t what organizers had in mind when they asked people to bring in their unused drugs. 

In the end, the FDA’s new mail-back program will likely have a greater impact as a public relations initiative to make the agency look good, rather than keeping unwanted opioids off the street. 

In a world where doctors are so reluctant to prescribe opioids, I don’t blame people for wanting to hold on to the opioids they’re able to get. In a PNN survey of thousands of pain patients, nearly a third (32%) admitted hoarding their unused opioids because they’re unsure if they’ll be able to get them in the future 

If we’re lucky, the program will accomplish at least one of the goals that the FDA’s Sokolowska laid out: “We want to ensure patients have access to opioid analgesics.”

Given the federal government's abysmal track record with opioids and pain care in general, I’ll believe that when I see it.

Drug Shortages Easing, But Pain Patients Still Have Problems Getting Opioids

By Pat Anson

Shortages of prescription drugs and other medications appear to be easing in the United States, but with tight supplies of oxycodone, hydrocodone and other opioids persisting.

As of September 30, the number of active drug shortages stands at 277, down from a record high of 323 at the end of last year, according to a new report from the American Society of Health-System Pharmacists (ASHP). The report found that shortages of drugs used for pain, anesthesia, chemotherapy and attention-deficit/hyperactivity disorder (ADHD) “continue to be problematic.”

Health systems also face significant shortages of medical grade intravenous (IV) and dialysis fluids, which have gotten worse in recent weeks due to production shortfalls in the southeast caused by Hurricanes Helene and Milton. To conserve supplies, some hospitals are giving patients Gatorade instead of IV electrolytes. The American College of Emergency Physicians also recommends using tap water to clean wounds rather than sterile irrigation fluids.

Over half of the drug manufacturers (60%) contacted by the ASHP did not provide a reason for the shortages, but others cited increased demand for certain drugs (14%), manufacturing problems (12%), business decisions (12%), and raw material shortages (2%).

The ASHP has also cited reduced DEA production quotas and the fallout from opioid litigation settlements, which have significantly reduced the supply of opioid medication and led to rationing at many pharmacies. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy.

Teva Pharmaceuticals, a large generic drug maker, recently discontinued production of potent fentanyl analgesics known as Transmucosal Immediate-Release Fentanyl Medicines (TIRF). That forced the FDA to end a program that supplied TIRF medication to about 150 patients, many of them suffering severe pain from late-stage cancer.

Teva has not made any public statements about its discontinuation of the TIRF drugs Actiq and Fentora. The most likely explanation for the discontinuation is that Teva’s bottom line was suffering due to the costs of opioid litigation. In 2022, Teva agreed to pay $4.25 billion to settle thousands of opioid liability lawsuits.

Opioids currently listed in short supply by the ASHP include oxycodone/acetaminophen tablets, oxycodone immediate-release tablets, hydrocodone/acetaminophen tablets, hydromorphone tablets and solution, fentanyl patches, fentanyl solution, and morphine solution. Most have been in shortage for over a year.

‘It’s So Hard to Find My Medications’

The Drug Enforcement Administration recently announced plans to further reduce the supply of prescription opioids in 2025, while raising production quotas for amphetamine and other stimulants used to treat ADHD.

Although the FDA advised the DEA that medical need for schedule II opioids will decline 6.6% next year, DEA is proposing only minor reductions in the supply of fentanyl, oxycodone, hydrocodone and hydromorphone, while keeping quotas unchanged for morphine and codeine. If the quotas are implemented, it would be the ninth consecutive year the opioid supply has been reduced.

Over 1,900 people submitted comments to the Federal Register on the DEA’s plans, many expressing frustration with chronic opioid shortages.

“It’s so hard to even find my medication anymore. I have to go from pharmacy to pharmacy and it causes so much anxiety. I feel so insecure and the unknown makes me sick,” wrote Sierra Shareiko. “It’s like kicking us down while we’re already down. We need to start being smart and looking into how much these medications are actually keeping us alive.”

“In the last year I have had to contact multiple pharmacies in order to get my monthly refill of opioid medication I take for a chronic disease I’ve dealt with for 16 years. Either the pharmacies are out of stock, or they will only fill prescriptions for acute pain,” said another patient. “By throttling production, you’re throwing an already precarious situation further into chaos. You’re putting pressure and stress on the entire medical system and it’s not solving any problems.”

One letter, signed by over two dozen geriatric and palliative care physicians in New York City, warned that any further cuts in the opioid supply would “cause significant harm” to patients.

“In my clinical experience, virtually every time we prescribe opioids for severe and disabling pain in the setting of serious illness, we are required to spend hours tracking down a pharmacy that has the medication in stock. Most do not because their suppliers can't get it for them,” wrote Dr. Diana Meier.

“Our inability to care effectively for our patients because of well-intended but harmful constraints on production and distribution of opioid analgesics is a major source of burn out, frustration, and anger among the already inadequate workforce available to care for the mostly older people living with serious and chronic illness.”

“As a recently retired pain doctor, I saw firsthand just how difficult opiate supply cutbacks made life for my patients. Some reported calling 20 or 30 pharmacies, or traveling a hundred miles, to find pharmacies that would fill their prescriptions,” said Dr. William Taylor. “These cutbacks are a backdoor way to deny medication to patients who have a legitimate medical need for opiate analgesics. There is no evidence that these cutbacks benefit patients in any way.”

The public comment period on the DEA’s proposed 2025 production quotas has ended. The agency is expected to release its final decision on drug quotas before the end of the year.

Opioids Are Effective at Treating Pain. Just Ask My Family

By Crystal Lindell

What if I told you that there was a medication that made it possible for my grandma to live at home instead of a nursing home? 

And that the same medication allowed my uncle to endure prostate cancer treatments long enough to see his cancer go into remission. And that it helped my mom avoid pneumonia after hip surgery. Or that this medication is the only reason I’m pain-free enough to be able to write this column?

But that’s not all. What if I told you the same medication helps me take care of my cats, as well as the cats at the local animal shelter where I volunteer? 

What if I told you that doctors hated this medication? And that many of them also hate anyone who takes it?.

In an age of opioid-phobia, it seems a lot of people – doctors in particular – have forgotten why opioid pain medications like Norco exist in the first place. And why they are such a miracle drug.

Over the summer, my grandma fractured her foot. After a couple of weeks in the hospital, she was transferred to a rehab facility to start the healing process. In mid-October, she was finally cleared to put some weight on her foot again, and last week she was able to come home. 

But she’s still not fully recovered and every movement still feels like climbing a mountain. In fact, standing up to go from her chair to the commode would still be impossible for her, if not for one very specific medical intervention: a 5mg hydrocodone tablet.

Yes, just one of those pills every six hours makes it possible for her to stand up to use the bathroom, walk to the kitchen, and visit with her new great-grandchild. 

Too bad her doctors are doing everything possible to refuse to prescribe it for her. Each one keeps pushing her off to a different specialist that they claim should actually be giving them to her.

The entire situation is made all the more frustrating because her chronic health issues mean she’s not allowed to take the pain medication most doctors try to push on patients: ibuprofen. 

Not to mention the fact that – at 82 years old – the main reason that doctors cite for refusing to prescribe opioids to my grandma doesn’t apply. At her age, she’s not likely to suddenly develop compulsive use behavior. And if she did, why would it matter? 

Doctors will sometimes claim that opioids aren’t effective at treating pain long term. But if a patient says they are still effective, then clearly that doesn’t apply.

Here we are in 2024, and we as a civilization have managed to harness the power of the poppy plant to such an extent that we can use it to help elderly patients enjoy their final years at home with loved ones, instead of being stuck in a depressing nursing home. But we refuse to use it. 

I’m tired of having to spend so much time countering people who think opioid pain medications are the root of all of society’s ills. That’s just not the case. Unfortunately, their constant complaints have managed to work the refs, so now we have to waste time begging for the bare minimum in pain treatment. 

In fact, if those same people would just look around a little bit, they would see the truth: opioids help millions of people lead better lives. And, if anything, they should be prescribed more, not less. 

Flawed Mayo Clinic Study Promotes Opioid Myths

By Crystal Lindell

A new study has been released analyzing why patients start taking opioids — but all the research actually does is perpetuate harmful myths about opioids and the patients who use them. 

The study, which was just published in the Journal of Pain, was conducted by researchers from the Mayo Clinic and the National Center for Complementary and Integrative Health. 

The researchers say this is “the first study to present nationally representative rates of incident prescription opioid use.” But it’s the headline from a Mayo Clinic article about the study that clarifies what the authors were actually trying to get at. It reads: “Who is choosing to use prescription opioids?”

“Choosing” – as though patients have any choice about whether or not they use opioids. 

Opioid medications are not sold over the counter, and many doctors today do everything possible to avoid prescribing them. So the idea that any patient can walk into a doctor’s office and “choose” opioids over alternative treatments is wildly naive, at best. 

I’ll go a step further and somewhat defend the doctors here: if a doctor is prescribing opioids in the current opioid-phobia environment, they are not doing it as a first-line treatment. They’ve  already tried non-opioid medications and non-pharmaceutical therapies, which didn’t work.

But let’s take a step back and look at exactly what the authors of the study claim their research found. In a nationwide survey of nearly 10,500 people conducted in 2019 and 2020, about 4% started using prescription opioids. Four percent isn’t much, but it was enough to surprise the researchers.

"One of the things that we noticed is that people are still utilizing opioids as an early resort or first line treatment, before trying non-opioid treatments first, which goes against best practice guidelines in healthcare," said lead author Ryan D'Souza, MD, a Mayo Clinic anesthesiologist. "This is a wake-up call to how high the incidence rate among new users continues to be."

A bit of a jump in my opinion, but let’s go with that. What are these "early resort or first-line” treatments that D’Souza and his co-author want patients to try before resorting to opioids? As they explain: "Nonpharmacologic modalities, over-the-counter medications, and other nonopioid analgesics as initial treatment for pain."

“Nonpharmacologic modalities” means things like physical therapy and cognitive therapy. “Over-the-counter medications and “nonopioid analgesics” means pain relievers like ibuprofen and acetaminophen (Advil and Tylenol) or prescription medications like gabapentin.

Well, I have some great news for the researchers who did this study: Every single patient asking a doctor for opioid pain medication has already tried Advil. 

It’s also worth noting that some of the data was collected in 2020, which is infamous for being a year that greatly disrupted medical care because of COVID. It was the kind of disruption that literally limited how much access patients had to physical therapy and in-person cognitive therapy. So yes, some patients may have resorted to opioids during that time.

Also, physical and cognitive therapy are both significantly more expensive than hydrocodone, even if you have insurance. Both therapies require multiple sessions — sometimes in the same week — and most insurance companies require a copay for each session. So the difference in price can be dramatic, not to mention the cost of time away from work and family to go to appointments. 

The other major flaw in their list of alternatives is that none of them are great at treating pain quickly. Physical therapy may help over a period of weeks or months, but it’s not going to be much help to an arthritis patient who needs to get work on Monday. And there’s little data showing medications like gabapentin are effective at all when it comes to pain. 

In fact, the researchers found that “ineffective pain treatment” was the primary reason people were given a new prescription for opioids. Other leading factors for opioid use are three or more visits to the ER in one year; having four or more painful conditions; and having two or more disabilities.

Anyone with that many strikes against them probably needs opioids, yet the authors are still troubled that “some participants are using opioids… instead of following various best-practice guidelines.”

As is the case for most medical research, both the data collection and the conclusions drawn by the authors seem to have been done with zero input from any actual patients. That’s the foundational problem for the entire study. None of the conclusions factor in real life situations. 

Studies like this one that demonize every single use of opioids would have a lot more sway if there were actually effective opioid alternatives available. As it stands now, patients do not have an option between “an effective, non-addictive pain medication” and “an effective, always addictive pain medication.” 

In reality, the options are usually between “ineffective, non-addictive medication” and “effective and rarely addictive medication.” 

Anyone who’s actually experienced real pain will tell you that when those are the choices, the “effective” medication wins every time. 

It’s so exhausting that we are still dealing with such flawed thinking from the medical community when it comes to opioids. I understand that opioids make an easy villain in healthcare, but opioids are not a magical, always-addictive medication — no matter how many times the medical community tries to convince us otherwise.

I know this because most patients who undergo general anesthesia are routinely given the opioid medication fentanyl — and none of them wake up post-op suddenly addicted to opioids. In fact, most people who take opioids in any setting never develop problematic use.

So we would be wise to remember that the real villain isn’t opioids. It’s the problem they’re trying to address: pain.

Survey Finds Patients and Doctors Unsatisfied with Treatments for Acute Pain

By Pat Anson

Nine out of ten (89%) patients who recently had short-term acute pain say it caused a major disruption in their lives, limiting their ability to sleep, exercise and enjoy leisure activity, according to a new survey. Many patients also expressed dissatisfaction with the pain medication they received and want to try a new one if their pain returns.

The survey was conducted by Vertex Pharmaceuticals, which is awaiting FDA approval of suzetrigine, its experimental non-opioid medication for acute pain. Vertex surveyed 1,001 adults and 547 doctors who were treated for or who treated acute pain. The company also commissioned a survey by the American Academy of Orthopaedic Surgeons (AAOS), which asked similar questions of 49 of its members who treated patients with moderate-to-severe pain from surgery.

The resulting report, “The State of Pain in America,” is obviously intended to drum up support for suzetrigine by showcasing dissatisfaction with current treatment options for acute pain. But the surveys also provide some interesting insights into what patients and doctors think about opioids and pain care in general.

“The Vertex and AAOS surveys underscore that treating acute pain in today’s health care landscape can be complex, as are the complexities that patients and health care providers have when personalizing pain management, highlighting the unmet need in this therapeutic area for more options,” Vertex said.

About 80 million adults receive treatment for acute pain in the U.S. each year, about half of whom receive an opioid, according to Vertex. Many also take acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief.

Nearly a third of patients (31%) said they stopped taking analgesics before their acute pain resolved and 77% said they would be interested in trying a different medication – clear indications of dissatisfaction with their pain care.

Patients were also concerned with how acute pain impacted their lives:

• 70% Limited their ability to walk and exercise

• 69% Limited their sleep

• 65% Limited their hobby or leisure activity

• 65% Made them feel irritable or emotionally drained

• Missed an average of 19 work days annually

The surveys also found that both patients and doctors were worried about the risk of opioid addiction:

• 49% of patients concerned about opioid addiction

• 78% of doctors concerned about patients becoming addicted to opioids

• 88% of doctors believe patients prefer to manage pain without opioids

• 67% of patients said they would request a non-opioid medication in the future

• 52% of patients want a pain medication with fewer side effects

In addition, 83% of providers and 74% of AAOS surgeons said there was a high need for a new class of non-opioid pain medication.

Whether suzetrigine is a solution to these issues is an open question. Unlike opioids, which act on pain receptors in the brain, suzetrigine is designed to block pain in the peripheral nervous system. That means it won’t have the same “liking” effects of opioids or be addictive.

But in clinical studies, suzetrigine was not more effective than a low dose of Vicodin in treating acute pain in patients recovering from minimally invasive surgeries.

The risk of a surgery patient misusing opioids or becoming addicted is actually quite low – less than one percent. One study even found that patients who received no opioids during surgery were more likely to have post-operative pain and require opioids during recovery.

Vertex hopes suzetrigine will be approved by the FDA in January for post-operative acute pain.  The company is also studying the drug as a treatment for pain caused by diabetic peripheral neuropathy and for lumbosacral radiculopathy.  

Poppy Seeds Draw More Scrutiny for Addiction Risk

By David Hilzenrath, Healthbeat

It sounds like a joke: poppy seeds infused with opioids.

Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy. People have died after drinking tea brewed from unwashed poppy seeds.

And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests.

Poppy seeds come from the plant that produces opium and from which painkillers such as morphine and codeine are derived. During harvesting and processing, the seeds can become coated with the opium fluid.

Members of the House and Senate have proposed legislation “to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.” The bill was one of several on the agenda for a Sept. 10 House hearing.

The day before the hearing, The Marshall Project and Reveal reported on a woman who ate a salad with poppy seed dressing before giving birth, tested positive at the hospital for opiates, was reported to child welfare, and saw her baby taken into protective custody. Almost two weeks passed before she was allowed to bring her baby home, the story said.

“It’s not an urban legend: Eating poppy seeds can cause diners to test positive for codeine on a urinalysis,” the Defense Department warned military personnel in 2023.

The U.S. Anti-Doping Agency long ago issued a similar warning to athletes.

The Center for Science in the Public Interest, a watchdog group, petitioned the FDA in 2021 to limit the opiate content of poppy seeds. In May, after more than three years with no response, it sued the agency to force action.

“So far the FDA has been negligent in protecting consumers,” said Steve Hacala, whose son died after consuming poppy seed tea and who has joined forces with CSPI. The lawsuit was put on hold in July, after the FDA said it would respond to the group’s petition by the end of February 2025.

The FDA did not answer questions for this article. The agency generally does not comment on litigation, spokesperson Courtney Rhodes said.

A 2021 study co-authored by CSPI personnel found more than 100 reports to poison control centers between 2000 and 2018 resulting from intentional abuse or misuse of poppy seeds, said CSPI scientist Eva Greenthal, one of the study’s authors.

Only rarely would baked goods or other food items containing washed poppy seeds trigger positive drug tests, doctors who have studied the issue said.

It’s “exquisitely doubtful” that the “relatively trivial” amount of morphine in an everything bagel or the like would cause anyone harm, said Irving Haber, a doctor who has written about poppy seeds, specializes in pain medicine, and signed the CSPI petition to the FDA.

Unwashed Seeds More Potent

On the other hand, tea made from large quantities of unwashed poppy seeds could lead to addiction and overdose, doctors said. The risks are heightened if the person drinking the brew is also consuming other opioids, such as prescription pain relievers.

Benjamin Lai, a physician who chairs a program on opioids at the Mayo Clinic in Rochester, Minnesota, said he has been treating a patient who developed long-term opioid addiction from consuming poppy seed tea. The patient, a man in his 30s, found it at a health food store and was under the impression it would help him relax and recover from gym workouts. After a few months, he tried to stop and experienced withdrawal symptoms, Lai said.

Another patient, an older woman, developed withdrawal symptoms under similar circumstances but responded well to treatment, Lai said.

Some websites tout poppy seed tea as offering health benefits. And some sellers “may use specific language such as ‘raw,’ ‘unprocessed,’ or ‘unwashed’ to signal that their products contain higher concentrations of opiates than properly processed seeds,” the CSPI lawsuit said.

Steve Hacala’s son, Stephen Hacala, a music teacher, had been experiencing anxiety and insomnia, for which poppy seed tea is promoted as a natural remedy, the lawsuit said. In 2016, at age 24, he ordered a bag of poppy seeds online, rinsed them with water, and consumed the rinse. He died of morphine poisoning.

The only source of morphine found in Stephen’s home, where he died, was commercially available poppy seeds, a medical examiner at the Arkansas State Crime Lab said in a letter to the father. The medical examiner wrote that poppy seeds “very likely” caused Stephen’s death.

Steve Hacala estimated that the quantity of poppy seeds found in a 1-liter plastic water bottle in his son’s home could have delivered more than 10 times a lethal dose.

Steve Hacala and his wife, Betty, have funded CSPI’s efforts to call attention to the issue. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

The lawsuit also cited mothers who, like those in the investigation by The Marshall Project and Reveal, ran afoul of rules meant to protect newborns. For example, though Jamie Silakowski had not used opioids while pregnant, she was initially prevented from leaving the hospital with her baby, the suit said.

Silakowski recalled that, before going to the hospital, she had eaten lemon poppy seed bread at Tim Hortons, a fast-food chain, CSPI said in its petition. “No one in the hospital believed Ms. Silakowski or appeared to be aware that the test results could occur from poppy seeds.”

People from child protective services made unannounced visits to her home, interviewed her other children, and questioned teachers at their school, she said in an interview.

While on maternity leave, she had to undergo drug testing, Silakowski said. “Peeing in front of someone like I’m a criminal — it was just mortifying.”

Even family members were questioning her, and there was nothing she could do to dispel doubts, she said. “Relationships were torn apart,” she said.

The parent company of Tim Hortons, Restaurant Brands International, which also owns Burger King and Popeyes, did not respond to questions from KFF Health News.

In July, The Washington Post reported that Trader Joe’s Everything but the Bagel seasoning was banned and being confiscated in South Korea because it contains poppy seeds. Trader Joe’s did not respond to inquiries for this article. The seasoning is listed for sale on the company’s website.

The U.S. Drug Enforcement Agency says unwashed poppy seeds can kill when used alone or in combination with other drugs. While poppy seeds are exempt from drug control under the Controlled Substances Act, opium contaminants on the seeds are not, the agency says. The Justice Department has brought criminal prosecutions over the sale of unwashed poppy seeds.

Meanwhile, the legislation to control poppy seed contamination has not gained much traction.

The Senate bill, introduced by Sen. Tom Cotton (R-Ark.), has two co-sponsors.

The House bill, introduced by Rep. Steve Womack (R-Ark.), has none. Though it was on the agenda, it didn’t come up at the recent hearing.

Healthbeat is a nonprofit newsroom covering public health published by Civic News Company and KFF Health News, a national newsroom that produces in-depth journalism about health issues.  

CDC Is Worried About Shortages of ADHD Stimulants. What About Rx Opioids?

By Pat Anson

The Centers for Disease Control and Prevention is worried that shortages of stimulant medication used to treat attention-deficit hyperactivity disorder (ADHD) may be forcing some patients to turn to street drugs or even suicide.

In a new report, the CDC estimates that 15.5 million U.S. adults have ADHD¸ a condition that causes inattention, impulsiveness and hyperactivity. About a third of those patients were prescribed a stimulant, but 71.5% of them had difficulty getting their prescription filled because of shortages.

“Shortages of stimulant medications in the United States have affected many persons with ADHD who rely on pharmacotherapy to appropriately treat their ADHD,” wrote lead author Brooke Staley, PhD, an epidemiologist at the CDC’s National Center on Birth Defects and Developmental Disabilities.

“Patients experiencing these difficulties might seek medication outside the regulated health care system, increasing their risk for overdose because of the prevalence of counterfeit pills in the illegal drug market, which might contain unexpected substances such as fentanyl.”

This is the second CDC report in recent months to warn about stimulant shortages. In a CDC Health Advisory released in June, the agency said ADHD patients who are unable to obtain Adderall and other stimulants are at risk of “social and emotional impairment, increased risk of drug or alcohol use disorder, unintentional injuries, such as motor vehicle crashes, and suicide.”

The CDC’s concern about ADHD patients is in marked contrast to its ongoing neglect of pain patients, who face similar shortages of opioid medication.

In a recent PNN survey, 90% of pain patients said they experienced delays or problems getting their opioid prescriptions filled at a pharmacy. Desperate for relief, some bought counterfeit medication or other illicit drugs; obtained opioids prescribed to another person; or used alcohol, cannabis and other substances to ease their pain. Nearly a third said they considered suicide because their pain was so severe.

In short, the very same risky behavior that concerns the CDC about ADHD patients.   

We asked the CDC if it was studying the impact of opioid shortages on pain patients and instead got a defense of the ADHD study.

“There has been limited information about (ADHD) diagnosis and treatment in adults and this analysis aimed to fill that information gap – providing the first national estimates on prevalence of adult ADHD in more than a decade. It is also the first national estimates to describe age at diagnosis and treatment, including telehealth and difficulty filling stimulant prescriptions,” a spokesperson said in an email.

It would not be unreasonable to say that the CDC shares some of the blame for chronic shortages of hydrocodone, oxycodone and other prescription opioids. The agency’s controversial 2016 opioid guideline paved the way for steep cuts in opioid prescribing, resulting in “serious harm” to patients who were rapidly tapered and left in uncontrolled pain. Some committed suicide.

The CDC guideline also greased the skids of opioid litigation by exaggerating the risk of opioid addiction and overdose. Faced with a tsunami of lawsuits, drug distributors and pharmacy chains agreed to ration the supply of opioids at individual pharmacies, and drug makers cut back on the production of opioids to avoid further liability. As recently as last month, Teva Pharmaceuticals stopped production of immediate-release fentanyl medicines, potent pain relievers that were relied on by dying cancer patients.

The CDC has been silent about opioid shortages – so have the FDA and DEA.

“We don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in a 2023 interview. 

Faced with complaints about shortages of ADHD medication, the DEA recently said it would raise the supply of stimulants that drug makers are allowed to produce in 2025, but would continue with its decade-long campaign to reduce the supply of opioids.

That discrepancy hasn’t been lost on pain sufferers.

“You’ve corrected course for ADHD drugs, now do the same for opioid pain analgesics,” one patient posted in a comment on the DEA’s plan. “Do not cut opioids production in 2025. The shortages across the country will be worse, with a corresponding increase in suffering and deaths among chronic pain patients.”

“These proposals will only further the pain and harm on a community of disabled individuals that did not ask to be disabled,” wrote Rebecca Meadows. “Would you want your mother, brother, sister, child or yourself to suffer unnecessarily due to unwarranted cutbacks in pain medications being made? The amount of people who suffer now is ridiculous but it’s only going to get worse if we continue on this path.”

A former CDC epidemiologist wrote a book about how the CDC’s “Disastrous War on Opioids” made the overdose crisis worse. Opioid overdoses have nearly doubled since the 2016 guideline was released.

“There are still significant restrictions on people in chronic pain for no apparent benefit. There continues to be very high rate of overdoses,” said author Charles LeBaron, MD. “I'm kind of a diehard public health guy. I want to see whether anything good happens. Nothing good happened. Time to reconsider.”