Oregon Medical Board Has ‘No Limits’ on Prescription Opioids

By Pat Anson, PNN Editor

The Oregon Medical Board has come full circle in its regulation and enforcement of pain management guidelines. After years of taking disciplinary action against doctors for prescribing high dose opioids without a “legitimate medical purpose,” the board has acknowledged that its policies had a chilling effect on doctors who no longer felt safe treating chronic pain with opioids.

“The Board is well aware some number of clinicians have shied away from long-term pain management in part or in whole for fear of Board sanctions. We wish it weren’t so, and the Board is hopeful the realignment in prescribing guidance will provide reassurance to those licensees caring for patients with long-term pain,” David Farris, MD, Medical Director of the Oregon Medical Board (OMB), recently wrote in the board’s newsletter.

The board’s “realignment” came a year after the Centers for Disease Control and Prevention revised its own opioid guideline to give doctors more flexibility in treating pain patients.

In 2016, the CDC initially recommended that daily opioid dosages not exceed 90 MME (morphine milligram equivalents), which was widely seen as a mandatory dose limit.

But after numerous reports of patients being rapidly tapered, going into withdrawal and dying by suicide, the CDC guidance was revised in 2022 to eliminate any dose thresholds. Physicians were instead urged to prescribe opioids cautiously at the “lowest possible effective dose.”   

“There are no set regulatory limits on the daily dosage of opioids that can be prescribed in Oregon. There is also not a requirement to rapidly taper or discontinue opioids for patients.”

— Oregon Medical Board

In a “Statement of Philosophy” adopted in January, the OMB urged doctors to read the CDC guideline and heed its advice about treating patients individually and to allow “shared decision making” about their treatment.

“In alignment with this statement and CDC guidelines, there are no set regulatory limits on the daily dosage of opioids that can be prescribed in Oregon. There is also not a requirement to rapidly taper or discontinue opioids for patients on existing opioid doses. The Board wants to ensure licensees accepting new patients on existing chronic opioid therapy do not feel pressured to rapidly change a patient’s current opioid dose,” the OMB said.

‘More Harm Than Good’

Opioids have been a contentious issue in Oregon for several years. In 2018, the state considered rule changes to its Medicaid program that would have limited coverage of opioids to just 90 days for patients with neck or back pain. The proposal, which would have forcibly tapered thousands of patients on long-term opioid therapy, was supported by Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.     

The plan was scrapped after pain management experts signed a joint letter warning that Oregon’s tapering plan was unsupported by treatment guidelines and would do “substantially more harm than good.”

The Medical Board’s decision to give more leeway to doctors reflects a growing awareness that the crackdown on opioids is harming pain patients and may be worsening the drug crisis.    

“The Board wishes to reassure and encourage licensees to assume the prescribing responsibilities for such patients, regardless of MME level, at least temporarily, in order to avoid patients going into withdrawal or turning to illicit sources,” Farris wrote.

“It is gratifying to see the OMB finally recognize that their arbitrary opioid dosing policies harmed people with chronic pain and the providers caring for them. It seems as though the Board may have been adversely affected by advice received from home state clinicians aligned with PROP, and, inevitably, the chickens have come home to roost in that regard,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management, who signed the 2018 joint letter.

“I hope this change in stated policy will be reflected in changes to Board investigations and to the state-developed CME (Continuing Medical Education) program on pain management that is mandated for all prescribers in the state. It's going to take years to repair the damage done so far, but I'm hoping the pendulum can finally come to rest somewhere near the midpoint of the extremes we've seen over the last 30 years.”

Opioid prescribing in Oregon has been falling for nearly a decade – as it has nationwide – but overdose deaths in the state keep rising. According to CDC data, Oregon has one of the lowest rates of fatal overdoses involving prescription opioids in the country. Deaths linked to illicit fentanyl, stimulants, methamphetamine and heroin are far more common in Oregon.  

A Pain Patient's Perspective on Opioid Prescribing

By Barby Ingle, PNN Columnist

It is essential to prescribe pain treatments that are appropriate and effective for each patient. I say that based on my own experiences as a patient, as well as thousands of others I have spoken with over the years as a friend and advocate.

Patients who need opioids, benzodiazepines, antidepressants and other medications should have access to them -- just as a heart patient has access to medication that keeps their heart functioning or a diabetic needs access to insulin.

People living with pain should also be offered individualized treatment. That could be anything from physical therapy and analgesics to surgical procedures and alternative therapies like acupuncture. I have tried over 100 different types of pain treatment; some have worked and others have not. It often made me feel like a guinea pig. Unnecessary surgery hurt me most in the end.

There are many public education campaigns underway to prevent addiction and overdoses by reducing the use of prescription opioids. These campaigns are repeated in the media, but the information does not always include facts or is presented in a misleading way.

For example, there is the DEA’s “One Pill Can Kill” campaign, which is aimed at raising awareness about a surge in counterfeit pills made with illicit fentanyl and other street drugs. Another is the CDC’s “Rx Awareness” campaign, which shares the stories of people whose lives were impacted by prescription opioids. The overall theme is that opioids are “addictive and dangerous.”  

Although well-intentioned, these campaigns have a tendency to demonize FDA-approved medications that have a lot of science and research behind them. Most people are unaware that fentanyl has been used safely and effectively for decades to treat severe pain and as an analgesic in millions of surgeries. Saying “one pill can kill” to a pain patient who has improved their life with a legally prescribed medication is disheartening.

I have seen this misinformation firsthand over the years and how it has put a damper on opioid prescribing. Physicians should prescribe opioids for pain when appropriate, but many are afraid to do so because of potential sanctions and legal threats. As a result, many providers won’t prescribe opioids or will only do so minimally and as a last resort.

Individualized Treatment

I believe each patient is different and should be treated as such. We need providers to operate on the assumption that each individual is unique and requires something different, even when they have the same disease or injury as someone else.

Physicians today can use pharmacogenomics to see if a patient’s DNA can affect how they respond to a treatment or what is chemically right for them. The dosage, brand, procedure and frequency will vary depending on each patient. I often bring my pharmacogenomics information to communicate more effectively with my providers, which benefits us both.

I also know that doing what is least invasive first and then progressing to other options is essential. Sometimes, surgery is the best option. Sometimes, opioids or other pain medications should be used first. Every medical provider should work at finding the treatment that most effectively suits the patient.

It is a considered best practice to prescribe opioids to someone in severe pain from sickle cell disease. Yet, when many sickle cell patients go to the ER or are admitted to a hospital, they are denied opioids because of hospital policy. What is the point of having a trained medical providers on staff if you won’t let them treat a patient the way they should be?

Denying pain relief is not only cruel, it can be the worst practice for everyone involved. For example, a man in severe chronic pain committed suicide after a doctor at a Kentucky pain clinic cut his opioid dose in half. The man’s family filed a lawsuit and won a $7 million judgement against the doctor and clinic.  

Ultimately, it should be the patient's responsibility to weigh the risks and benefits of any treatment, after getting input from their provider and conducting due diligence. Unfortunately, there are many obstacles standing in the way of that. One of the biggest is finding a doctor willing to prescribe pain medication. In addition, there are insurance restrictions, the cost of medication, and other logistical issues such as transportation to appointments.

Here in Arizona, patients must see their provider every month to renew a prescription for a controlled substance. Policies like that were put in place to “protect” pain patients, but only added extra costs, burdens and stigmas to them.

Patient-Physician Communication

How can we change the narrative about opioid prescribing? We can start by emphasizing the importance of effective communication between physicians and patients, even those as young as elementary school. Early education on how to talk to medical professionals and advocate for yourself is vital. I see this as one of the most critical things for patients to do.

Communication and trust are essential. Patients need to know when to take medication, how much to take, and what the potential side effects are. They also need to be able to express how the medication is working and what their symptoms are. Patients should feel comfortable asking questions and discussing their pain management plan. Physicians need to listen, provide feedback and give advice when needed.

Individualized treatment plans should be tailored to the patient’s age, gender, medical history, lifestyle and other factors.  That will help ensure that the treatment is effective and also reduce the risk of adverse reactions and potential complications. Collaborative decision-making makes patients feel more comfortable, confident in their treatment plan, and more likely to follow it.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

Stimulants Involved in Growing Number of Fentanyl Overdoses

By Pat Anson, PNN Editor

The number of drug deaths involving both fentanyl and stimulants has soared in recent years, according to a new UCLA study that highlights the complex and changing nature of the U.S. overdose crisis.

Stimulants such as cocaine and methamphetamine are now involved in nearly a third of fentanyl-related overdoses, the most of any other drug class. Fentanyl is a synthetic opioid up to 100 times more potent than morphine and 50 times as potent as heroin.

In 2010, researchers say there were only 235 fatal overdoses in the U.S. involving illicit fentanyl and stimulants. In 2021, there were 34,429 drug deaths linked to fentanyl and stimulants, a 14,550% increase in a little over a decade.

"We're now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the US overdose crisis," said lead author Joseph Friedman, PhD, an addiction researcher at the David Geffen School of Medicine at UCLA. "Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances. This poses many health risks and new challenges for health care providers.

“We have data and medical expertise about treating opioid use disorders, but comparatively little experience with the combination of opioids and stimulants together, or opioids mixed with other drugs. This makes it hard to stabilize people medically who are withdrawing from polysubstance use."

People who overdose on stimulants and other non-opioid substances mixed with fentanyl may not be as responsive to naloxone, which only works as an antidote to opioids.

The study findings, published in the journal Addiction, highlight the four “waves” of the overdose crisis, which began with an increase in deaths from prescription opioids (Wave 1) in the early 2000s, followed by a rise in heroin deaths (Wave 2) in 2010, and fentanyl-related overdoses in 2013 (Wave 3). The fourth wave — overdoses from fentanyl and stimulants — began in 2015 and continues to escalate.

The Four Waves of Overdose Crisis

SOURCE: ADDICTION

Since cocaine, methamphetamine and other stimulants are not opioids, the findings undercut the long-held theory that the overdose crisis started with prescription opioids and is still being fueled by people addicted to them. Deaths involving prescription opioids and heroin have been in decline for several years.

Researchers found that fentanyl/stimulant deaths disproportionately affect African Americans and Native Americans. There are also geographical patterns to fentanyl/stimulant use. In the northeast US, fentanyl is usually combined with cocaine, while in the south and western US, fentanyl is most commonly found with methamphetamine.

"We suspect this pattern reflects the rising availability of, and preference for, low-cost, high-purity methamphetamine throughout the US, and the fact that the Northeast has a well-entrenched pattern of illicit cocaine use that has so far resisted the complete takeover by methamphetamine seen elsewhere in the country," Friedman said.

In addition to its low cost, drug users say methamphetamine helps prolong fentanyl’s “high” and delays the onset of withdrawal symptoms.  

Counterfeit pills laced with fentanyl – which are frequently made to look like oxycodone or alprazolam (Xanax) – represent about a quarter of all illicit fentanyl seizures. Researchers say it is difficult to track deaths involving counterfeit pills because they are often mistaken for legitimate medication, so the data is not completely reliable.

In its most recent update on the overdose crisis, the CDC estimates there were a record 111,355 drug deaths in the 12-month period ending April 2023 -- about a thousand more deaths than the year before. Fentanyl and its analogues were involved in nearly 70% of the overdoses, stimulants were linked to about a third of them, and cocaine was involved in about a quarter of the drug deaths.

CDC Recommends New Covid Boosters

By Arthur Allen, KFF Health News

Everyone over the age of 6 months should get the latest covid-19 booster, a federal expert panel recommended Tuesday after hearing an estimate that universal vaccination could prevent 100,000 more hospitalizations each year than if only the elderly were vaccinated.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 for the motion after months of debate about whether to limit its recommendation to high-risk groups. A day earlier, the FDA approved the new booster, stating it was safe and effective at protecting against the covid variants currently circulating in the U.S.

After the last booster was released, in 2022, only 17% of the U.S. population got it — compared with the roughly half of the nation who got the first booster after it became available in fall 2021. Broader uptake was hurt by pandemic weariness and evidence the shots don’t always prevent covid infections. But those who did get the shot were far less likely to get very sick or die, according to data presented at Tuesday’s meeting.

The virus sometimes causes severe illness even in those without underlying conditions, causing more deaths in children than other vaccine-preventable diseases, as chickenpox did before vaccines against those pathogens were universally recommended.

The number of hospitalized patients with covid has ticked up modestly in recent weeks, CDC data shows, and infectious disease experts anticipate a surge in the late fall and winter.

The shots are made by Moderna and by Pfizer and its German partner, BioNTech, which have decided to charge up to $130 a shot. They have launched national marketing campaigns to encourage vaccination. The advisory committee deferred a decision on a third booster, produced by Novavax, because the FDA hasn’t yet approved it. Here’s what to know:

Who Should Get a Booster Shot?

The CDC advises that everyone over 6 months old should, for the broader benefit of all. Those at highest risk of serious disease include babies and toddlers, the elderly, pregnant women, and people with chronic health conditions including obesity. The risks are lower — though not zero — for everyone else. The vaccines, we’ve learned, tend to prevent infection in most people for only a few months. But they do a good job of preventing hospitalization and death, and by at least diminishing infections they may slow spread of the disease to the vulnerable, whose immune systems may be too weak to generate a good response to the vaccine.

Pablo Sánchez, a pediatrics professor at The Ohio State University who was the lone dissenter on the CDC panel, said he was worried the boosters hadn’t been tested enough, especially in kids. The vaccine strain in the new boosters was approved only in June, so nearly all the tests were done in mice or monkeys. However, nearly identical vaccines have been given safely to billions of people worldwide.

When Should You Get It?

The vaccine makers say they’ll begin rolling out the vaccine this week. If you’re in a high-risk group and haven’t been vaccinated or been sick with covid in the past two months, you could get it right away, says John Moore, an immunology expert at Weill Cornell Medical College. If you plan to travel this holiday season, as he does, Moore said, it would make sense to push your shot to late October or early November, to maximize the period in which protection induced by the vaccine is still high.

Who Pays For It?

When the ACIP recommends a vaccine for children, the government is legally obligated to guarantee kids free coverage, and the same holds for commercial insurance coverage of adult vaccines.

For the 25 to 30 million uninsured adults, the federal government created the Bridge Access Program. It will pay for rural and community health centers, as well as Walgreens, CVS, and some independent pharmacies, to provide covid shots for free. Manufacturers have agreed to donate some of the doses, CDC officials said.

Will New Booster Work Against Current Variants?

It should. More than 90% of currently circulating strains are closely related to the variant selected for the booster earlier this year, and studies showed the vaccines produced ample antibodies against most of them. The shots also appeared to produce a good immune response against a divergent strain that initially worried people, called BA.2.86. That strain represents fewer than 1% of cases currently. Moore calls it a “nothingburger.”

Why Are People Still Skeptical About Vaccines?

Experience with the covid vaccines has shown that their protection against hospitalization and death lasts longer than their protection against illness, which wanes relatively quickly, and this has created widespread skepticism.

Most people in the U.S. have been ill with covid and most have been vaccinated at least once, which together are generally enough to prevent grave illness, if not infection — in most people. Many doctors think the focus should be on vaccinating those truly at risk.

What About Getting Other Vaccines?

People tend to get sick in the late fall because they’re inside more and may be traveling and gathering in large family groups. This fall, for the first time, there’s a vaccine — for older adults — against respiratory syncytial virus. Kathryn Edwards, a 75-year-old Vanderbilt University pediatrician, plans to get all three shots but “probably won’t get them all together,” she said.

Covid “can have a punch” and some of the RSV vaccines and the flu shot that’s recommended for people 65 and older also can cause sore arms and, sometimes, fever or other symptoms. A hint emerged from data earlier this year that people who got flu and covid shots together might be at slightly higher risk of stroke. That linkage seems to have faded after further study, but it still might be safer not to get them together.

Pfizer and Moderna are both testing combination vaccines, with the first flu-covid shot to be available as early as next year. Although Pfizer’s shot has been approved in the European Union, Japan, and South Korea, and Moderna has won approval in Japan and Canada. Rollouts will start in the U.S. and other countries this week.

Unlike in earlier periods of the pandemic, mandates for the booster are unlikely. But “it’s important for people to have access to the vaccine if they want it,” said panel member Beth Bell, a professor of public health at the University of Washington.

“Having said that, it’s clear the risk is not equal, and the messaging needs to clarify that a lot of older people and people with underlying conditions are dying, and they really need to get a booster,” she said.

ACIP member Sarah Long, a pediatrician at Children’s Hospital of Philadelphia, voted for a universal recommendation but said she worried it was not enough. “I think we’ll recommend it and nobody will get it,” she said. “The people who need it most won’t get it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

CDC Report ‘Likely Underestimated’ Deaths Linked to Counterfeit Drugs

By Pat Anson, PNN Editor

A new report from the Centers for Disease Control and Prevention found that fatal overdoses in the U.S. from counterfeit medication more than doubled in recent years, with 93% of those deaths involving illicit fentanyl.

Deaths from counterfeit pills rose from 2% of all overdoses in the third quarter of 2019 to 4.7% of drug deaths in the last quarter of 2021, according to the CDC’s Morbidity and Mortality Weekly Report (MMWR). The overdose rate from fake medication was three times higher in western U.S. states (14.7%). 

However, due the unreliability of death certificates, witnesses and coroner investigations, as well as other flaws in the study’s methodology, the MMWR report acknowledges that the number of deaths involving counterfeit medication is “likely underestimated.”

CDC researchers only looked at overdose data from 34 states and the District of Columbia, identifying 2,437 deaths linked to counterfeit pills during the 30-month study period.

Nearly 106,700 people in the U.S. died from drug overdoses in 2021, so if the 4.7% death rate was applied to that year alone, that would suggest there were over 5,000 deaths nationwide involving counterfeit medication.

Even that estimate is probably on the low end, because CDC researchers focused on counterfeit pills made to look like oxycodone and the anti-anxiety drug alprazolam (Xanax).

While “Mexican Oxy” – blue tablets that look like 30mg oxycodone – are favored by counterfeiters, fake pills are also designed to look like Vicodin, Norco, Adderall, and many other medications. Deaths from those pills were not counted.  

Importantly, whether a death was even linked to fake medication “depended largely on scene or witness evidence of pill use” and other anecdotal evidence, rather than toxicology tests on the pills or the actual people who died.

And while pills are obviously designed to be taken orally, the MMWR report only includes “noningestion routes of drug use,” such as smoking, snorting or injection, which require the pills to be ground into powder or liquefied. CDC researchers considered data on the oral ingestion of counterfeit pills so unreliable, “that information is not presented” in the report.

Many of these details on the study’s strange methodology are buried in the footnotes of the MMWR report, which a casual reader could easily miss. 

Not surprisingly, given the limitations on data, smoking was found to have an outsized role in overdose deaths. According to the MMWR, nearly 40% of the deaths linked to counterfeit medication involved smoking – a misleading statistic, given the study’s flaws. But that didn’t stop researchers from drawing conclusions or recommending “safer smoking practices.”

“The higher percentage of deaths with evidence of drug use by smoking might reflect recent general shifts from injecting drugs to smoking them in western states or could be specific to counterfeit pill use methods,” wrote lead author Julie O’Donnell, PhD, an epidemiologist at the CDC’s National Center for Injury Prevention and Control.

“Harm reduction services that expand outreach to persons using drugs by methods other than injection, such as smoking, and provide education about safer smoking practices and risks related to smoking, might be most successful at addressing diverse drug use patterns.”

There’s a safer way to smoke illicit fentanyl?

This is the CDC’s first MMWR report to look exclusively at deaths caused by fake pills, a public health crisis that the agency has been slow to acknowledge. The DEA started warning about a “fentanyl crisis” as far back as 2016, a time when the CDC was preoccupied with its guideline to reduce opioid prescribing.

There were major flaws in CDC research even back then. The agency eventually admitted that thousands of overdose deaths linked to illicit fentanyl and other street drugs were misclassified as deaths caused by prescription opioids. Some deaths that involved more than one drug were counted multiple times.

Australian Guideline Calls for Safer Opioid Tapering

By Pat Anson, PNN Editor

Public health experts in Australia have released what is being called the first international guideline to help primary care doctors safely reduce or stop prescribing opioids to adults with chronic non-cancer pain.

The Guideline for Deprescribing Opioid Analgesics contains 11 recommendations developed by a panel of general practitioners, pain specialists, addiction specialists, pharmacists, nurses and physiotherapists. The guideline emphasizes slow and individualized tapering for patients when long-term opioid use does not improve their pain and quality of life or when they experience adverse side effects. Tapering is not recommended for anyone nearing the end-of-life.

“Internationally, we were seeing significant harms from opioids, but also significant harms from unsolicited and abrupt opioid cessation. It was clear that recommendations to support safe and person-centred opioid deprescribing were required,” said lead author Aili Langford, PhD, a pharmacist and Research Fellow at Centre for Medicine Use and Safety, Monash University.

Millions of pain patients in the U.S. were tapered or cut off cold turkey after the CDC released its 2016 opioid prescribing guideline. Both the American Medical Association and the FDA warned that rapid tapering was causing “serious harm” to patients, including withdrawal, uncontrolled pain, substance abuse and suicide.

In response to that criticism, the revised 2022 CDC guideline took a more cautious approach to tapering, recommending a dose reduction of just 10% a month, a much slower rate than the 10% a week that the agency previously recommended.

The U.S. Department of Veterans Affairs and Department of Defense (VA/DoD) also modified their approach to tapering, which at one time called for tapers of up to 20% every four weeks.  The updated VA/DoD guideline says there is “insufficient evidence to recommend for or against any specific tapering strategies.”

The Australian guideline doesn’t get caught up in fractions or percentages. It simply calls for “gradual tapering” that is tailored to each patient’s needs and preferences. A key recommendation is to discuss tapering as early as possible with patients, to develop a plan when they are first prescribed opioids.  

“Shared decision-making and ensuring that patients have ways to manage their pain are essential when a deprescribing plan is being discussed,” said Liz Marles, MD, a general practitioner and clinical director at the Australian Commission on Safety and Quality in Health Care.  

“These new guidelines further support appropriate use of opioid analgesics and how to safely prescribe and stop prescribing them. They ask clinicians to consider reducing or stopping opioids when the risk of harm outweighs the benefits for the individual.”

One in five adults in Australia have chronic pain, but few actually wind up taking opioids long-term. The guideline authors estimate that only 5% of opioid “naive” patients become long-term users, well below misleading claims by anti-opioid activists that over 25% of pain patients develop opioid dependence or opioid use disorder.

“I am curious to know how many people who are on chronic opioid therapy feel a need to be tapered,” said Lynn Webster, MD, a pain management expert and Senior Fellow at the Center for U.S. Policy.  “Only 5% of opioid-naïve patients remain on opioids for 3 months or longer. Considering the fact that about 10% of the population has severe enough pain to affect quality of life, this statistic argues against the theory that just being exposed to an opioid leads to chronic opioid use.”

Webster says most of the recommendations in the Australian guideline are practical, but he’s concerned that some of the evidence used to support them is “misunderstood and misleading.”

“They make it abundantly clear that tapering should not be forced and that there are serious consequences to forced tapering. But they also use the common yet flawed statement that there is little evidence that opioids are effective for chronic non-cancer pain. Of course, the lack of evidence is not evidence,” Webster said.

Although opioids have been used for thousands of years for pain relief, the clinical evidence for or against their use remains thin. Most of the evidence used to support the Australian guideline was deemed by the authors to be insufficient, unclear or weak. Only one of the 11 tapering recommendations was supported by evidence of “moderate certainty.”

Burden of Pain: How the CDC and DEA Criminalized Medicine

(Jay K. Joshi, MD, is a primary care physician in Indiana who spent nearly a year in prison after pleading guilty to prescribing opioids without a “legitimate medical need” to an undercover DEA agent who was posing as a pain patient. Joshi now regrets that guilty plea and is trying to vacate his conviction due to alleged DEA misconduct.

While in prison, Joshi began writing “Burden of Pain: A Physician’s Journey through the Opioid Epidemic.” His book is a cautionary tale about misguided public health policy and overzealous law enforcement, which often portray doctors as drug dealers and patients as addicts.

PNN editor Pat Anson recently spoke with Joshi, who is practicing medicine again and hopes to regain his license to prescribe opioids. This interview has been edited for content and clarity.)

JAY K. JOSHI, MD

Anson: Dr. Joshi, who is your book intended for and what is the main message you're trying to send?

Joshi: The book really is for the general public and those that have a vested interest in helping to rectify misguided federal policy, as it pertains to not just the opioid epidemic, but the overdose crisis as a whole.

My main message is that we have to understand that healthcare has a lot of uncertainty and complexity. And if we just use simplified rubrics, like cookie cutter medical guidelines or restrictive laws, we're going to create unintended consequences. It's time that we start to re-examine clinical decisions and health policy as a whole, so that we can make better informed decisions.

Anson: Do you think the general public has a good understanding of the opioid crisis and what caused it? Or is there misinformation going around that they've bought into?

Joshi: I would say there's a strong degree of misrepresentation among policymakers, who should have known better before and certainly should know better now. I think the narrative of opioid prescriptions running amok and creating this overdose crisis is a story that’s taken on a life of its own.

Did prescription opioids contribute to the overdose crisis that we see now? Yes. Was it the main driving factor? No. But there were trends in drug use and drug policy through the 2000’s and 2010’s that falsely conflated prescription opioids with illicit opioids. Policymakers should now understand that there are fundamental differences in how opioids are abused versus how they're used in a proper clinical setting.

Anson: Given what's transpired over the last few years, with overdoses soaring from illicit fentanyl and opioid prescriptions declining, do you think policymakers now know better?

Joshi: You know, in life as a general rule of thumb, often you learn more about what a person doesn't say, than what they do say. And this kind of hollow resonance in connecting fentanyl overdoses to previous manifestations of the overdose crisis to me is a glaring omission of responsibility from federal policymakers at the CDC level and law enforcement at the DEA and state level.

They’ve failed to acknowledge that the current fentanyl crisis is a manifestation of restrictive and overly simplified opioid policies that began nearly a decade ago. And I think the fact that people are not correlating that when the data clearly shows it indicates there is a willful understanding and a willful intent to not accept responsibility for prior failures and opioid policies.

Anson: Do you think the CDC and the DEA made the fentanyl crisis worse?

Joshi: It's difficult to say because when you use the word “worse,” then you almost have to apply some sort of causality. I like to look at the overdose crisis a little differently.

Did the CDC with their opioid policy guidelines contribute to the trends and overdoses that we're seeing now? Yes. By not recognizing that the guidelines would be codified into law and policy, and deliberately affect clinical decision making. They're not taking accountability for all the damaging effects. So, by that logic, you can say the CDC made the opioid epidemic worse.

But I would instead reframe it to say the CDC needs to better educate itself. What you see from them is a conflation of words, reflecting a lack of proper understanding. That's how I would define the revised 2022 CDC opioid prescribing guideline.

They talk a lot about nuances. They talk a lot about “uncertainty,” although not using that word as much as I believe that they should. But then eventually they revert to the same policy trend of creating overly simplified stipulations using morphine milligram equivalents (MME) as this rubric of clinical care, even though it was never intended to be used as a clinical decision-making tool.

The CDC needs to be better aware of its own conflicts of interest in the leadership making policy decisions. We can go down line by line looking at these individuals and assessing their conflicts of interest. And I certainly have seen things that would be quite alarming for anybody who values scientific objectivity.

But I feel like when you go down that pathway, you're simply entrenching people in their own lease, meaning the CDC will simply double down and say,”No, what we're doing is right” and the DEA will simply double down and say,” No, what we're doing is right.”

Anson: Do you think the CDC should even have an opioid guideline?

Joshi: It is odd that a public health organization would get involved with something that has, for all intents and purposes, a direct patient to physician relevancy. It's hard for me to understand how the CDC initially thought that when the guidelines made it a public health issue. It was almost as if it became a self-fulfilling prophecy.

The CDC felt like prescription opioids were a public health issue, and therefore created guidelines that affected the patient-physician relationship, thereby creating undue stigmatization in a clinical encounter that should otherwise be based upon a foundation of trust and respect.

And by doing so, they almost exacerbated the overdose crisis into a public health issue. It's very difficult to understand why they felt like those guidelines would help, as opposed to focusing on keeping prescription opioids within the framework of the patient-physician encounter, as it already had been.

I guess they were looking at rising overdose rates and conflated illicit opioids, heroin and fentanyl with prescription opioids. I'm not sure where that direct line of logic really came from. It's difficult to really justify that.

Anson: And what about the DEA? As you very well know, a lot of doctors have stopped prescribing opioids or have really scaled back the doses that they give to patients, because they don't want to go to prison like you did.

Joshi: Definitely, and I can understand that. What's interesting is that I've had direct engagements with DEA officers, and from my perspective they lack the necessary understanding of prescription opioids and the benefit it provides patients. They lack the healthcare context.

What the DEA does is correlate the clinical encounter with what you would see in a routine drug transaction. In their eyes, having a hammer as the only tool, everything looks like a nail. So the drug dealer in Mexico running Chinese products through a drug cartel entering the United States is cognitively equivalent to a physician treating patients with chronic pain.

They don't have the ability to discern context and the role clinical need plays in how patients are treated. And I think that really does an injustice to both the patients and the physicians, because effectively the only tool the DEA has to address prescription opioid use is fear. And when you use fear in the clinical context, you’ve harmed the most vulnerable patients. It's a shame that the DEA is not acknowledging this.

I wrote an op/ed in Medpage Today about a month ago, in which I asked the DEA to take a stance on harm reduction. Many medical societies talk about how harm reduction is a better overall policy to help patients. But medical societies are not implementing the laws, the DEA is implementing the laws.

So regardless of how high-minded the policies may be, unless implementation of the policies aligns with intent, you're not going to have patients being treated the way that they should be. And I think what the DEA really needs to do is to assess its role in the clinical encounter and make honest determinations on whether they have the capabilities to understand clinical need for opioids as it pertains to patients with chronic pain or acute pain. I think the DEA is lacking in that capacity.

Anson: Is the DEA practicing medicine? They say they don't.

Joshi: I know. And I disagree. I would say that the DEA is very much involved in the practice of medicine. If you are influencing clinical decisions through fear, you are engaging in the practice of medicine.

What is clinical medicine? If you present to me with headache and vision changes, and I checked your vitals and see that you have extremely high blood pressure, I'm going to consider you as somebody in hypertensive crisis. I'm making that decision based upon the facts presented to me and then, based upon that decision, I will implement a certain form of treatment. Clinical medicine is a series of decisions made in the face of uncertainty.

Should I trust my blood pressure monitor that the readings are correct? Should I trust you when you say that you have a headache and vision changes? How much of that uncertainty is simply assumed to be true when any clinical decision is made?

Now, the moment you incorporate fear into that clinical decision making, you're influencing how the decisions are made and the eventual course of clinical action.  So very much the DEA is practicing medicine, and I would greatly appreciate if they were honest about that.

Anson: You've obviously given this a lot of thought and, at the same time, you don't sound that bitter about what happened to you. Why is that?

Joshi: You know, when I was in federal prison, I was extremely depressed. I lost my medical practice. I lost my freedom. But I always felt like, in the end, things would turn out right and the truth would come out. Whether that was a delusional belief sitting in a federal prison, I don't know. But I held onto that belief.

It's through that belief that I improved my writing abilities and hand wrote the first version of “Burden of Pain.” It’s through that belief that I regained my medical license and was reinstated as a Medicare provider.

I don't feel bitter because I feel that I have a responsibility to patients and to physicians who might be going through similar situations. And if I can behave in a certain way that is productive, that can turn what I went through into an overall good for patients and for society as a whole, then I’ll feel like what I went through was worth it.

“Burden of Pain” and other books are featured in PNN’s Suggested Reading section.

My Life Is on the Line Due to Rx Opioid Shortages

By Christine Kucera, Guest Columnist

On May 24, I had my regularly scheduled pain management appointment. The prescription for my normal regimen of 10mg oxycodone was sent electronically to my local CVS pharmacy. About an hour later, I received a text from CVS saying they received the prescription from my doctor.

I followed up later through their automated system. That is the moment of shocking revelation when I learned that my prescription was not going to be filled on time, and that it may not be ready until a week after my fill date.

Utterly panicked, heart racing, thinking and speaking a mile a minute, I contacted the pharmacy. They confirmed they were out of 10mg oxycodone tablets.

“What am I supposed to do?” I asked. A woman who I don’t know replied that I should try contacting other pharmacies.

Really? I can’t do that. Pharmacies won’t tell me, the patient, if they have a supply of a controlled substance. So she looked it up and said it looks like “X” pharmacy has it and that I should have my doctor send the prescription there. Unfortunately, by the time my provider received the message, it was too late.

I made multiple calls to another pharmacy and they were extremely rude. I called my pharmacy again. This time I spoke with a pharmacist that knew me. He was very understanding, as we discussed what to do next.

CHRISTINE KUCERA

We came up with a plan. He said to have my doctor send him a prescription for 5mg oxycodone. I immediately emailed my provider about the shortage and asked him to send a new prescription for 5mg, since they were out of 10mg tablets.

It was a very long night and I was extremely anxious waiting for a reply from my provider. As a long-term opioid patient of 30 years with intractable pain, I’ve been through the unimaginable, especially after the CDC published its first opioid guideline. Since 2016, I’ve been force tapered to suboptimal treatment levels, denied pain medication during multiple hospitalizations, and told to take Tylenol.

A surgeon even used prescription fentanyl on me during an interventional procedure after being told it doesn’t work on me – leaving me awake and screaming during the procedure. That’s just to name a few examples. Believe me, there are many more.

My thoughts are racing out of control. I can’t do this anymore. I can’t live life with unrelenting, unmanaged pain all day, every day. I’m barely holding on now, trying hard not give up hope. It’s not easy living in a body that’s under assault from an invisible invader, leaving my entire body riddled with rare diseases, along with severe bone, nerve, connective tissue and organ pain.

As a person with severe medically induced PTSD, I can fully recall all of the previous times I was forced off my managed regime of opiate medication. This time it’s going to be at the hands of the DEA, which has intentionally created shortages of oxycodone.

Next day arrives, a new prescription for 5mg is sent and I sigh with relief. It was short lived. Another pharmacist said my insurance company won’t cover the 5mg substitute without prior authorization. Completely losing control of my emotions, I asked why do I need another prior authorization?  My daily limit of 90 morphine milligram equivalents (MME) didn’t change, just the dose of the tablets

“It’s because of daily quantity limits,” the pharmacist replied.

Are you freaking serious?  I’m out of oxycodone as of today and you’re saying I can’t have 2 weeks of a substitute because there is no supply anywhere of 10mg and my insurance has quantity limits on 5mg doses?  I was angry and upset. This is so wrong! What am I supposed to do?

To that, the pharmacist says, “You can pay out of pocket.”

I didn’t have a choice, although I knew what happens from paying out of pocket with cash and sending prescriptions to new pharmacies. Those are red flags for prescription drug monitoring programs (PDMPs).

What’s next CDC and DEA? You’ve fabricated the great Opioid Lie and created policies that affect all pain care in all settings. Created new burdens for disabled and chronically ill patients. Created an opioid guideline that doesn’t allow for individualized treatment and places limits on prescriptions. You’ve shackled doctors with no options but to provide inadequate pain care or abandon patients altogether.

Now patients and their providers are having to deal with DEA created shortages of essential medicines. This has got to stop! Pain patients have never been the driver behind the overdose crisis. Anti-opioid prohibition policies are harming, torturing and killing U.S. citizens.

What do I do? There are no protections or even a set of procedures in place to assist patients and providers when there are shortages of controlled substances. It really is a nightmare situation. I feel helpless. The shortage is not my fault, the restrictions have gone too far, and my life is on the line.

Christine Kucera lives with psoriatic arthritis, spondyloarthropy, spondylitis, polyarthritis, sacroiliitis, degenerative joint disease, dermatomyositis, mixed connective tissue disease, spinal radiculopathy, hypoparathyroidism, rare endocrine tumors, psoriasis, endometriosis stage IV, pelvic adhesive disease, and other painful conditions. 

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

Do you have a “My Story” to share? Pain News Network invites other readers to share their stories about living with pain and treating it. We are particularly interested in your experiences dealing with current drug shortages. Send your stories to editor@painnewsnetwork.org.

‘No Reliable Evidence’ That Antidepressants Work for Chronic Pain

By Pat Anson, PNN Editor

Medical guidelines in the United States and United Kingdom may recommend antidepressants for treating chronic pain, but there is “no reliable evidence” that the medications actually work for that purpose, according to a new Cochrane review.

Cochrane reviews are considered the gold standard in medical research because they use robust methodology to gather good quality evidence, while dismissing poor quality research.

A team of UK researchers, led by scientists at the University of Southampton, spent two years examining 176 clinical trials involving nearly 30,000 patients who were prescribed antidepressants for pain. Among the drugs studied were fluoxetine (Prozac), sertraline (Zoloft), amitriptyline (Elavil), milnacipran (Savella), citalopram (Celexa), paroxetine (Paxil) and duloxetine (Cymbalta).

“Our review found no reliable evidence for the long-term efficacy of any antidepressant, and no reliable evidence for their safety for chronic pain at any point. Though we did find that duloxetine provided short-term pain relief for patients we studied, we remain concerned about its possible long-term harm due to the gaps in current evidence,” said lead author Tamar Pincus, PhD, a Psychology Professor at the University of Southampton.

“This is a global public health concern. Chronic pain is a problem for millions who are prescribed antidepressants without sufficient scientific proof they help, nor an understanding of the long-term impact on health.”

In the United States, duloxetine is FDA-approved for fibromyalgia, diabetic neuropathy and musculoskeletal pain. The recently updated CDC guideline recommends that duloxetine and other SNRI antidepressants be used for fibromyalgia and neuropathy, because they provide “small to moderate improvements in chronic pain and function.”

The UK’s National Institute for Health and Care Excellence (NICE) guideline goes even further, stating that antidepressants are better than opioids and other analgesics in treating fibromyalgia, chronic headache, Complex Regional Pain Syndrome (CRPS), musculoskeletal pain and other types of “primary chronic pain” for which there is no known cause.   

The authors of the Cochrane review say regulators in the US and UK should reconsider their recommendations.

“We are calling on governing health bodies NICE and the FDA to update their guidelines to reflect the new scientific evidence, and on funders to stop supporting small and flawed trials. Evidence synthesis is often complex and nuanced but the evidence underpinning the use of these treatments is not equivalent, so current treatment modalities are hard to justify,” said co-author Gavin Stewart, PhD, a statistician at Newcastle University.

Amitriptyline is one of the most commonly prescribed antidepressants for chronic pain in the world. In the last year, around 10 million prescriptions for amitriptyline were given to patients in England for pain, about twice the number prescribed for depression. Many other antidepressants are also prescribed “off-label” for pain, despite limited evidence to support their use.

“Though previous investigations show that some antidepressants might relieve pain, there has never been a comprehensive study examining all medications across all chronic conditions – until now,” said co-author Hollie Birkinshaw, PhD, a Research Associate at the University of Southampton.

“The only reliable evidence is for duloxetine. Adopting a person-centered approach is critical to treatment and, when patients and clinicians decide together to try antidepressants, they should start from the drug for which there is good evidence.”

The reviewers say duloxetine was the highest-rated antidepressant for treating fibromyalgia, musculoskeletal and neuropathic pain. Standard doses of duloxetine were just as effective as higher ones. Milnacipran was also effective at reducing pain, although the evidence was weaker.

“We simply cannot tell about other antidepressants because sufficiently good studies are not available – but it does not mean that people should stop taking prescribed medication without consulting their GP,” said Pincus.

A common complaint of patients who take duloxetine is that it makes them dizzy and nauseous. Many quickly become dependent on the drug and then have severe withdrawal symptoms when they stop taking it.

Several previous studies have also raised questions about using antidepressants for pain. A recent review of over two dozen clinical trials by Australian researchers found little evidence to support the use of antidepressants in pain management. Nearly half of the trials had ties or funding from the pharmaceutical industry.

CDC Study Shows Oxycodone Plays Minor Role in Overdose Crisis

By Pat Anson, PNN Editor

A new study by the CDC highlights the sharply rising death toll in the U.S. caused by illicit fentanyl, while at the same time revealing the minor role played by oxycodone in the nation’s overdose crisis.

The study, released this week by the CDC’s National Center for Health Statistics, looked at overdose death rates from 2016 to 2021. Deaths involving fentanyl more than tripled during that period, rising from 5.7 deaths per 100,000 people in 2016 to 21.6 deaths per 100,000 in 2021. Drug deaths involving methamphetamine and cocaine also rose sharply, while fatal overdoses involving heroin declined.

And what about oxycodone, the most commonly prescribed opioid pain medication? It turns out oxycodone has always played a relatively minor role in the overdose crisis, although regulators and public health officials said otherwise in a concerted campaign against all prescription opioids.

“Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug overdose epidemic,” then-CDC director Dr. Thomas Frieden said in a 2016 news release.

But the facts don’t support Frieden’s claim. In 2016, the year the CDC released its controversial opioid prescribing guideline, there were only 1.9 deaths per 100,000 people that involved oxycodone. By 2021, the rate had fallen 21% to 1.5 deaths -- well below the death rates of fentanyl, methamphetamine, cocaine and heroin.   

Drug Overdose Deaths in U.S. (2016-2021)

SOURCE: CDC

CDC researchers used an unusual method to conduct this study. Instead of relying on medical ICD-10 codes in death certificates, which lump drugs together into broad categories, the CDC used a “literal text” analysis.

“To address the limitations of ICD–10- coded mortality data, the National Center for Health Statistics has developed a method that searches the literal text of death certificates to identify mentions of specific drugs and other substances involved in the death. Death certificate literal text is the written information provided by the medical certifier, usually a medical examiner or coroner for drug overdose deaths, that describes the causes, manner, and circumstances contributing to the death,” the researchers explained.

Flawed Data

The literal text method is not foolproof, but it’s an improvement over the ICD-10 codes, which the CDC admitted in 2018 “significantly inflate” the number of deaths involving prescription opioids — flawed data that Frieden used to make his “key driver” of the epidemic claim in 2016.

How inflated were the overdose numbers back then?  Using the old ICD-10 method, which counted illicit fentanyl as a prescription opioid, Frieden’s CDC estimated that nearly 32,500 Americans died from overdoses of opioid medication in 2016. The death toll was later revised downward to about 17,000 overdoses after the CDC came clean about its flawed methodology.

Patient advocate Richard “Red” Lawhern has long been suspicious of CDC data, including studies that use literal text analysis.  

“CDC suggests an incidence of drug overdose deaths ‘involving’ oxycodone at only 1.5 per 100,000.  But they neatly avoid telling us that such a rate is so low that it confounds the non-uniformity of reporting from county to county, creating such statistical noise that the contribution of this agent (oxycodone) to overdose mortality is too small to accurately measure or report,” Lawhern said.  

Another problem is the qualifications of county coroners and medical examiners varies. Some are elected to their positions without any medical training or experience. The death certificates they fill out usually don’t say if a prescription drug was obtained legally or illicitly, or what specific drug or combination of substances caused the death. That is determined later by a toxicology test. As a result, a drug may be “involved” in a death and be listed on the death certificate, but have little or nothing to do with someone’s demise.

“It is startling that CDC has so consistently and deliberately conspired to disguise the fact that oxycodone really isn't significant in drug overdose mortality, and probably never has been,” Lawhern told PNN. 

Of course, every death is a tragedy in some way, regardless of the cause or substance involved. The graphic below helps bring oxycodone’s role into more context – comparing the five leading causes of death in 2021 to those involving fentanyl, oxycodone and the other drugs.

SOURCE: CDC

Despite the minor role played by oxycodone in 2021 deaths, efforts continue to restrict its availability. This year the Drug Enforcement Administration reduced the supply of oxycodone for the seventh consecutive year. Since their peak in 2013, DEA production quotas for oxycodone have fallen by 65 percent. The tightened supply has resulted in recent reports of oxycodone shortages and patients unable to get their prescriptions filled.

The DEA justifies the cuts by saying it is concerned about diversion and abuse, but the agency’s own data shows that less than one percent of legally prescribed oxycodone (0.3%) is diverted to someone it was not intended for.

New CDC Guideline: Too Little, Too Late for Chronic Pain Patients

By Sam Whitehead and Andy Miller, Kaiser Health News

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won't do the same. “If something should happen to him, there's nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

Opioid Guideline Revised

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,’’ said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

Patients Still Not Getting Needed Medication

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

DANNY AND GRETCHEN ELLIOT

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug, along with MS Contin, are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

Fentanyl Linked to 94% of Overdose Deaths in Massachusetts

By Pat Anson, PNN Editor

There’s good and bad news in the latest report on overdose deaths in Massachusetts. State health officials say drug deaths were down slightly in the first nine months of 2022, compared to the same period last year. But deaths involving fentanyl – most likely illicit fentanyl -- rose to 94% of opioid-related overdoses, a record high.

Massachusetts was one of the first states in the U.S. to expand the use of toxicology tests to look for the presence of certain drugs involved in opioid overdoses, instead of just relying on death certificates and coroner reports. That makes its overdose data more accurate.

In the first nine months of 2022, there were 1,340 confirmed opioid-related overdose deaths in Massachusetts, and officials expect that to reach about 1,696 deaths by the end of the year. That’s 25 fewer deaths than in 2021, a decrease of 1.5 percent.

Nationally, drug overdose deaths also appear to be slowing. The CDC estimates there were 107,735 U.S. overdose deaths in the 12-month period ending in July 2022, down from over 110,000 deaths in the 12-month period that ended in March, 2022. Illicit fentanyl, a synthetic opioid about 50 to 100 times more potent than morphine, is involved in the vast majority of those deaths.

Deaths in Massachusetts involving a fentanyl have been rising for over a decade, from nearly 42% of opioid-related overdoses in 2014 to 94% this year. Over that same period, deaths involving prescription opioids such as oxycodone and hydrocodone have steadily declined from about 35% to 11% of overdoses in 2022.

More people are now dying in Massachusetts after ingesting fentanyl, cocaine, alcohol or benzodiazepines such as Xanax than from pain medication. Deaths linked to opioid medication fell by 30% in just one year, which coincides with a steep decline in prescriptions in Massachusetts over the past decade.   

Drugs Involved in Massachusetts Opioid-Related Overdose Deaths

Massachusetts Department of Public Health

“Every life lost to opioid overdose is its own tragedy,” Public Health Commissioner Margret Cooke said in a statement. “With this report, we are encouraged by the decrease, however modest, in opioid-related overdose deaths in Massachusetts so far this year. We will continue to build on our data-driven and equity-based public health approach as we address the impacts of the opioid epidemic and the COVID-19 pandemic, especially among vulnerable populations.”

Health officials say the illicit drug supply in Massachusetts is “heavily contaminated” with illicit fentanyl, which is frequently used in the manufacture of counterfeit medication sold on the street.

Pharmaceutical fentanyl is used as a surgical analgesic and in patches and lozenges to treat severe pain, but only small amounts are diverted for abuse. The DEA estimates that only 0.01% of prescription fentanyl is diverted for use by someone it was not intended for.

It's important to note that the presence of a drug found in a toxicology screen doesn’t mean it was the cause of someone’s death. Multiples substances are frequently involved in opioid overdoses, and the official cause of death is a clinical decision made by coroners and medical examiners.

Toxicology tests alone also don’t reveal if a prescribed drug was intended for the decedent, or if it was bought, stolen or borrowed by them. An earlier study of drug deaths in Massachusetts found that only 1.3% of overdose victims had a prescription for the opioid medication involved in their deaths.

The vast majority of patients prescribed opioids use them responsibly and don’t go doctor shopping. The Massachusetts Department of Public Health estimates that only 0.6% of patients who were prescribed an opioid this year had an “activity of concern,” such as getting prescriptions from multiple providers or having them filled at multiple pharmacies.

DEA Plans Further Cuts in Rx Opioid Supply

By Pat Anson, PNN Editor

For the seventh consecutive year, the U.S. Drug Enforcement Administration is planning to cut the supply of prescription opioids, reducing them in 2023 to levels not seen in nearly two decades.

DEA sets production quotas for opioids and other controlled substances annually, after consulting with the CDC, FDA and individual states about their projected medical and research needs. Based on that input, the DEA is lowering the supply of Schedule II opioids such as oxycodone and hydrocodone by about 5 percent next year.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2023 will decline on average 5.3 percent from calendar year 2022 levels. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” the DEA said in a notice published in the Federal Register.   

The production cut in Schedule II opioids is not as steep as in prior years, but continues a trend that began a decade ago. Since their peak in 2013, production quotas have fallen by 65% for oxycodone and 73% for hydrocodone, the two most widely prescribed opioids.

OXYCODONE PRODUCTION QUOTAS (KILOGRAMS)

SOURCE: DEA

The primary goal of the DEA in lowering opioid production is to reduce the risk of diversion, abuse and overdose, but it’s hard to find any evidence the policy is working. Prescription opioid use has fallen by 48% in the last five years, but opioid overdose deaths have climbed to record levels, fueled primarily by street drugs made with illicit fentanyl, a synthetic opioid 50 to 100 times stronger than morphine.

Although DEA is arresting and prosecuting illicit fentanyl dealers, it also continues to actively target doctors who prescribe high doses of opioids. This month it suspended the DEA license of a California doctor for unknown reasons, which led to the death of a chronic pain patient and his wife in a double suicide.

“It’s the end of the road for me with doctors,” Danny Elliott posted on Twitter a few days before his death. Elliott had lived with severe headaches for over two decades and was despondent that he was out of pain medication and unable to find a new doctor.

Low Risk of Diversion    

DEA is required under federal law to estimate the amount of prescription opioids that will be diverted through loss or theft, and then subtract it from the annual production quota. But those estimates reveal just how small the opioid diversion problem actually is.

Using information gathered from prescription drug monitoring programs (PDMPs), pharmacies, hospitals and others in the drug supply chain, DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) will be diverted for use by someone they were not intended for.

The DEA’s 2023 production quotas are also based on an old recommendation from the CDC that prescribers should “avoid increasing dosages of opioids beyond 90 MME for patients with chronic pain.”  CDC recently revised its opioid guideline to remove the 90 MME dosage threshold. The new guideline is more flexible and encourages doctors to make treatment decisions based on the individual needs of the each pain patient and not on any hard limits.

The DEA is accepting public comments on its production quotas until Thursday, November 17. The public response so far has been muted – only 47 comments as of this writing -- likely because the quotas have received little publicity from the media or the DEA itself.

Most of the comments that have been received are critical of DEA plans to reduce the supply of amphetamines and other stimulants used in treating attention deficit hyperactivity disorder (ADHD).  Some of those drugs are already in short supply, but DEA said it has “grown increasingly concerned” that ADHD medications are being diverted and abused by young adults.

To leave your comment on the DEA’s 2023 production quotas, click here.

FDA Conducting Review of Opioid Regulations

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has launched an extensive review of its opioid regulations, with the goal of reducing overdoses and making revisions “to support appropriate use of opioid analgesics.”

In a blog post, FDA commissioner Robert Califf, MD, acknowledged the overdose crisis has “evolved beyond prescription opioids” and is now largely driven by illicit fentanyl and other street drugs. But he was vague about whether FDA would loosen restrictions on opioid pain medication or tighten them further.

“While the FDA’s previous strategies have largely focused on opioid use and overdoses, the evolving nature of the overdose crisis calls for both a new approach and honest reflection about what the FDA can do differently moving forward,” Califf said. “For example, during my confirmation process, I committed to undertaking a review of our opioid decisions, including labeling. We have initiated this review with the intended goal of understanding what revisions are needed to support appropriate use of opioid analgesics. Our ‘lessons learned’ will actively inform our future approach.”

One of the lessons learned by the CDC over the past few years is that rigid opioid prescribing guidelines have been harmful to patients and need to be “individualized and flexible.” The agency is currently in the process of revising its 2016 opioid guideline, with the goal of releasing an updated guideline late this year.

It’s not clear if the FDA is moving in a similar direction. One of the priorities for the agency’s new Overdose Prevention Framework is to “improve pain management and patient outcomes” – not by making opioids more accessible, but by reducing “unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.” 

Califf said the agency was studying the need for mandatory prescriber education about opioids, including a national continuing education program about the use of opioids to manage pain. Most medical schools in the U.S. and Canada do not require a course in pain education and few even offer pain management as an elective.

The FDA may also tighten the rules for getting new opioids approved, including a requirement that drug makers demonstrate that their products offer material safety advantages over existing opioid analgesics. At the same time, the agency is planning to release new guidance to speed up the development of non-opioid and non-addictive treatments for chronic pain.

This is the 70-year old Califf’s second stint as FDA commissioner, having previously served in that role during the Obama administration. He was confirmed for a second time by the U.S. Senate last December by a narrow 50 to 46 vote. At the time, he promised an extensive review of the FDA’s opioid regulations to counteract complaints that the agency did little to prevent opioid misuse and was too accommodating to drug makers.

Federal efforts to reduce drug overdoses by limiting opioid prescriptions have largely failed. While opioid prescribing has fallen by 48% over the past five years, overdoses soared to a record 107,000 drug deaths in 2021, driven primarily by illicit fentanyl.

A recent study found no “direct correlation” between opioid prescribing and overdoses. Another analysis of overdose deaths in 2020 found that prescription opioids ranked well behind illicit fentanyl, alcohol, cocaine, methamphetamine and heroin as the leading cause of drug deaths.   

Computer Algorithms Improve Timeliness of Overdose Data

By Pat Anson, PNN Editor

An automated process using computer algorithms to analyze death certificates would speed up and improve data collection on drug overdose deaths, according to a new study by UCLA researchers.

The current system used to track U.S. overdose deaths relies on medical examiners and county coroners – including some with little medical training -- to determine the cause of death and drugs involved. Death certificates are then sent to local jurisdictions or the Centers for Disease Control and Prevention, which codes them according to the International Statistical Classification of Diseases and Related Health Problems, Tenth Edition (ICD-10).

The coding process is manual and time consuming, resulting in delays of several months before the deaths are included in CDC overdose data. With drug deaths at record levels and more dangerous substances entering the illicit drug supply, researchers say that antiquated system delays an effective public health response.

"The overdose crisis in America is the number one cause of death in young adults, but we don't know the actual number of overdose deaths until months after the fact," said lead author David Goodman-Meza, MD, assistant professor of medicine in the division of infectious diseases at the David Geffen School of Medicine at UCLA.

"We also don't know the number of overdoses in our communities, as rapidly released data is only available at the state level, at best. We need systems that get this data out fast and at a local level so public health can respond. Machine learning and natural language processing can help bridge this gap."

Goodman-Meza and his colleagues used computer algorithms to analyze the text for keywords in nearly 35,500 death certificates from nine U.S. counties in 2020. The counties include major cities such as Chicago, Los Angeles, San Diego and Milwaukee.

The researchers say their automated system demonstrated “excellent diagnostic performance” in classifying the drugs involved in overdoses.

“We found that for most substances evaluated, the performance of these algorithms was perfect or near perfect. These models could be used to automate classification of unstructured free-text, thus avoiding the manual and time-consuming process of individually reading each entry and classifying them to a specific substance,” researchers reported in JAMA Network Open.

“Excellent performance was shown for multiple substances, including any opioid, heroin, fentanyl, methamphetamine, cocaine, and alcohol using models for general text. Yet for prescription opioids and benzodiazepines, there was a considerable performance gap.”

That “performance gap” is due in part to weaknesses in the drug classification system, which lumps many synthetic opioids under the same ICD-10 code, including fentanyl, fentanyl analogs, tramadol and buprenorphine – a semi-synthetic opioid used in the addiction treatment drug Suboxone.

In the past, CDC has classified all drug deaths using that code as “prescription opioid overdoses” even though the drugs may have been illicit --- which is the case for the vast majority of deaths involving fentanyl. This resulted in government estimates of prescription opioid overdoses being significantly inflated for many years.

Using the computer algorithms developed at UCLA, prescription opioids ranked far behind fentanyl, alcohol and other substances identified as the cause of death in 8,738 overdoses.

Drugs Involved in 2020 Overdose Deaths in 9 U.S. Counties

Source: JAMA Network Open

Until recently, there was a 6-month time lag in drug deaths being counted in the CDC’s monthly Provisional Drug Overdose Death Counts report. The timeliness of the reports were improved earlier this year to a 4-month delay, but Goodman-Meza says they could be improved even more.  

"If these algorithms are embedded within medical examiner's offices, the time could be reduced to as early as toxicology testing is completed, which could be about three weeks after the death," he said.