FDA Approves New Non-Opioid Pain Reliever

By Pat Anson

Despite lackluster results in clinical trials, the U.S. Food and Drug Administration has approved a new non-opioid pain reliever for moderate to severe acute pain in adults.

Journavx (suzetrigine) is the first new medication for acute, short-term pain in over two decades. Unlike opioids, Journavx blocks pain signals in the peripheral nervous system, not in the brain, so it doesn’t have the same “liking” effects of opioids, which can lead to dependence or addiction.

The FDA calls its approval “an important public health milestone.”

"A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency's designations to expedite the drug's development and review underscore FDA's commitment to approving safe and effective alternatives to opioids for pain management," said Jacqueline Corrigan-Curay, MD, acting director of the FDA's Center for Drug Evaluation and Research.

Journavx was developed by Vertex Pharmaceuticals, which anticipates the drug to be used primarily for relieving post-operative pain or trauma. It is also being studied as a treatment for diabetic peripheral neuropathy and other types of chronic pain.

“This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,” said Jessica Oswald, MD, a Vertex consultant and Associate Physician in Emergency Medicine and Pain Medicine in San Diego.

“I believe Journavx could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed.”

VERTEX IMAGE

The results from clinical trials suggest that Journavx is a mild pain reliever, at best.

In Phase 3 clinical studies of acute pain after minimally invasive surgeries, Journavx was no more effective than a low-dose combination of hydrocodone and acetaminophen, more commonly known as Vicodin.

In a recent Phase 2 study, Journavx was essentially no better than a placebo in relieving chronic back and hip pain caused by lumbosacral radiculopathy.

A recent report by ICER, an independent, non-profit research institute, said there were “uncertainties” about the efficacy and safety of Journavx.

“We have concerns about as-yet-unknown harms of suzetrigine as we would for any drug with a new mechanism of action; we are particularly concerned about whether there could be an increased risk for cardiac arrhythmias… and possible acute renal injury given a study in people with diabetes,” ICER said. “The above uncertainties inform our ratings that the evidence for suzetrigine for the treatment of acute pain in comparison with no systemic treatment, in comparison with opioid analgesics, and in comparison with NSAIDs are all promising but inconclusive.”

Journavx is being priced by Vertex at a wholesale cost for $15.50 per 50mg pill. When taken twice a day for acute pain, ICER estimates the cost at $420 for a one-week course. By comparison, a supply of 100 Vicodin tablets costs about $142.

The FDA’s approval of Journavx coincides with implementation of the NOPAIN Act, which makes non-opioid analgesics in outpatient surgical settings eligible for higher Medicare reimbursement rates.  

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

Is the Opioid Epidemic Really Ending?

By Dr. Charles LeBaron 

From all the self-congratulations by outgoing Biden administration officials about a 15% decrease in overdose deaths last year, one might conclude that the opioid epidemic is coming to an end. However, drug overdoses remain the #1 killer of adults aged 15 to 45, causing more deaths than automobiles and firearms combined.

So even if this “disappearing epidemic” continues at its current pace – about 98,000 fatal overdoses annually -- nearly a million Americans will die of overdoses within the next ten years. 

The carnage is taking place amid a startling paradox: many severely ill persons with a clearly legitimate need for pain control have grave difficulties obtaining opioid medications adequate to make their existence less of a living hell. This worst-case scenario is the legacy of past policy failures – failures that need not be repeated, if incoming Trump administration officials can take a moment to consult our history and apply its lessons. 

In the 1990s, as has been extensively chronicled, large pharmaceutical companies began aggressively promoting proprietary opioid preparations. By the mid-2010s, the United States, with 5% of the world’s population, was estimated to consume 80% of the world’s opioids. For Americans recovering from surgery, 91% received opioids, compared to just 5% in the rest of the world for the same operations.  

Opioid overdose deaths rose in parallel to opioid prescriptions – which became so numerous that the number of pills prescribed was technically enough to kill every American. Whereupon the Centers for Disease Control and Prevention (CDC) stepped in. The CDC’s 2016 opioid guideline, developed with almost no meaningful input from clinicians who treat pain, laid out a series of recommendations on who should get opioids, at what dosage, and for what duration. 

Essentially no attention was paid at the time to antidotes for overdoses or the treatment of dependence. Public and private insurers, eager for cost savings, rapidly adopted the CDC’s dosage restrictions, as did pharmacy chains under attack for their lucrative role in opioid sales. The Drug Enforcement Administration also lent a hand by imposing manufacturing caps on the five major opioid pain medications.  

Within two years, opioid prescribing rates had decreased dramatically in major specialties: for primary care clinicians they dropped 40%, cancer specialists down 60%, and ER docs down 71%. Overall prescription rates fell back to 1990s levels. Success was proclaimed. 

‘Inhuman Punishment’

Then the full consequences of inflexible dosage limits by non-clinicians became apparent. More than 80% of chronic pain patients said they now had more pain and a worse quality of life. The number of cancer patients and survivors with opioid prescriptions decreased by more than half. Suicides by patients cut off from opioids increased. And almost 80% of primary care physicians reported they were reluctant to prescribe opioids for any reason.  

Even when opioids were prescribed, patients often found that their opioid medication was unavailable because of the artificial scarcity created by opioid litigation and the DEA’s manufacturing caps. Patient and professional organizations protested. A group of 274 academic experts (including two former “drug czars”) sent a protest petition to CDC.  

Human Rights Watch, an organization best known for exposing torture by totalitarian regimes, issued a hundred-page report, suggesting that CDC policies could be considered to violate basic human rights by imposing “cruel, degrading, and inhuman punishment” on those whose only crime was to be in severe pain.  

But CDC held the line, pointing proudly to a drop of a few percent in the 2018 overdose rate. Lost in the triumphalism was the fact that the overdose rate was creeping up from a little-known opioid called fentanyl, which is 100 times more potent than morphine.

The 2018 overdose downturn proved to be a pause, during which a new set of entrepreneurs entered the market, acquiring fentanyl components from suppliers in China, using pill presses to make them look like FDA-approved medications, and then transporting them to a gig distribution system in the US.

The Mexican cartels were meeting an unmet need. The pharmaceutical companies had helped create the need. And rigid implementation of the restrictive CDC guidelines, aided by DEA manufacturing caps, helped assure the need went unmet.

Overdoses, primarily from illicit fentanyl, exploded after the 2018 pause, doubling in the six years following implementation of the CDC recommendations, a surge particularly acute right in the CDC’s own backyard of Georgia.

So here we are in 2025, with a few percent reduction in overdoses and once again a repetition of 2018 triumphalism.

Meanwhile, overdoses have increased seven-fold from illicit carfentanil, a veterinary opioid so potent that a delivery box could overdose the entire US population.

We remain in the paradoxical situation where evermore dangerous illicit opioids from abroad are easily purchased on a street corner, while medically-prescribed opioids, manufactured under the FDA’s safety and purity standards, are hard to obtain by those who legitimately need them.

We Could Do Better

I worked for more than 28 years at CDC as an epidemic control specialist, during which time I also did clinical work with addicts and drug dealers in Appalachia and in the federal penal system.

Several years ago, as a patient with life-threatening staph spinal abscesses, I received months of high-dose opioids for severe pain. Many pain patients wake up each morning, as I did then, praying that the day’s struggle for some semblance of pain control will succeed against odds that seem so perversely, so specifically, so implacably stacked against them.

Out of these personal and professional experiences, I concluded that we could do better by the millions currently in severe inescapable pain, as well as the million projected to die by overdose in the upcoming decade. I wrote a book about the opioid crisis, "Greed to Do Good: The Untold Story of CDC's Disastrous War on Opioids."

In brief, here’s what I suggest should be minimal elements of an effective opioid epidemic response:

• We have an ongoing mass poisoning. We have an antidote. Naloxone (Narcan) should be deployed on a scale equivalent to the mass poisoning.

• For the estimated 50 million Americans with chronic pain, and especially the 17 million for whom pain limits life and basic functioning, opioids prescribed by a physician should not be so difficult to obtain that patients turn to cartels as America’s pharmacist.

• Standards guiding pain treatment should come from medical organizations with clinical expertise – not from pharmaceutical marketers, government bureaucrats, or the police.

• Artificial scarcity for legitimate opioids through DEA caps on manufacturing merely shifts demand to illicit opioids. This policy should be abandoned.

• For the estimated 6 million Americans with opioid use disorder, only 20% are in treatment. Addiction is a relapsing-remitting condition, with treatment outcomes similar to those for other chronic conditions, such as diabetes, asthma and hypertension, where behavioral setbacks are also common. To really wreak havoc on cartel profits, while saving American taxpayers millions of dollars in unnecessary incarceration costs, treatment needs to be made as accessible as it is for other chronic conditions

One-in-ten American families has lost an immediate family member to a drug overdose. The dead are our brothers, sisters, husbands, wives, children and newborns. The sooner we recognize that our policies result in more deaths and more persons in pain, the sooner we will bring this self-inflicted massacre to a close. 

A graduate of Princeton University and Harvard Medical School, Charles W. LeBaron, MD, is board certified in both internal medicine and pediatrics. For more than 28 years, he worked as a medical epidemiologist at the CDC.  

Dr. LeBaron’s book “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids” can be purchased from online booksellers or the publisher (Amplify Publishing in Herndon VA). For book reviews, see Kirkus or BlueInk.

Where Have All the Pain Doctors Gone?

By Pat Anson

In recent years, it’s become increasingly difficult for a patient in pain to find a new doctor. Many physicians have stopped treating pain, retired early or switched specialties, rather than run the risk of being investigated or even put in prison for prescribing opioids.

In a recent PNN survey, one in five patients said they couldn’t find a doctor to treat their pain. Others said they were abandoned or discharged by a physician (12%) or had a doctor who retired from clinical practice (14%).   

“All the doctors in this area are justifiably terrified to involve themselves at all with opiates,” one patient told us. “It's now going on 6 months that I've been hunting for a doctor who isn't afraid to continue my former opiate regimen, which only made my pain tolerable, allowing me some small quality of life. I don't know what to do next and I am truly at my wits end.”

“This year my doctor retired, then 8 months later the hospital closed the pain clinic. I'm waiting to get into a new pain clinic that is 200 miles away. Every local doctor refuses to prescribe my pain meds, so now I'm forced to travel 4 hours each way to see a new doctor,” another patient said.

“I have to fly to another state for my medical care,” said another person in pain. “Many patients I’ve met over the last ten years have not had the same care. They can’t afford the medical treatment and can’t find doctors to help.”

A new study suggests the problem is only going to get worse, because medical schools are seeing fewer anesthesiology residents applying for fellowships in pain medicine. The number of applications fell 45% from 2019 to 2023.

“While the demand for pain specialists is growing in the U.S., the pipeline of new doctors to fill these roles is drying up,” says lead author Scott Pritzlaff, MD, an associate professor in the UC Davis Department of Anesthesiology and Pain Medicine and director of the school’s Pain Medicine Fellowship program.

Pritzlaff and his colleagues analyzed data from the National Resident Matching Program (NRMP), Electronic Residency Application Service (ERAS) and a special report from the American Association of Medical Colleagues (AAMC) to see trends in medical specialties.

Their findings, recently published in the journal Pain Practice, show significant changes in specialties that are being driven by market forces and professional preferences. While demand and pay scales for general anesthesiologists have increased, the number of anesthesiology trainees applying for pain medicine fellowships is dropping. The trend is most notable among female residents applying for the specialty, which has fallen by 27.5%, compared to a 9.8% decline in male applicants.

“Fewer doctors choosing pain medicine means longer wait times, rushed care and fewer treatment options for patients suffering from chronic pain,” Pritzlaff said. “In a country already grappling with an opioid crisis, this could leave millions without the specialized care they need to manage their pain safely and effectively.”

Co-author Chinar Sanghvi, MD, says the drop in applications is partially driven by opioid lawsuits against drug makers and criminal cases against doctors, which have made medical residents and trainees leery about practicing pain medicine.

“For trainees observing this during their formative years, it may have created a perception of pain medicine as a high-risk specialty — both legally and ethically,” said Sanghvi, an assistant clinical professor in the UC Davis Department of Anesthesiology who mentors first and second year-medical students. “This fear of litigation, coupled with the stigma surrounding opioid prescribing, could discourage aspiring physicians from entering the field.”

The data also revealed some upward trends. Applications from residents for physical medicine and rehabilitation fellowships rose almost 33%, while residents specializing in emergency medicine increased by 190%.

General anesthesiologists have some of the best paying jobs in medicine, with median salaries of nearly $499,000 a year. For an anesthesiologist to specialize in pain medicine requires an additional year of training and pays less. With high demand and higher salaries, many doctors skip the extra training and enter the workforce right after completing their anesthesiology residency.

To help attract new residents, the UC Davis Health Division of Pain Medicine increased its recruiting efforts and became more active on social media. The efforts helped UC Davis fill its fellowship slots in pain medicine despite the national downturn.

“Pain medicine is caught in a strange paradox. On one hand, pain is one of the biggest public health problems in America, costing billions annually. On the other, the field is underappreciated and underfunded,” said senior author David Copenhaver, MD, a professor in the UC Davis Department of Anesthesiology and Pain Medicine and chief of the Division of Pain Medicine. “This decline isn’t just about numbers — it’s a wake-up call for the future of pain care in America.”

Walgreens Joins CVS in Fighting DOJ Opioid Lawsuits

By Crystal Lindel

Walgreens is fighting back against a new Department of Justice lawsuit, using a tactic that mirrors CVS’s public response to a similar DOJ lawsuit filed last month. 

In both lawsuits, the DOJ claims that Walgreens and 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.

CVS and Walgreens are also accused of pressuring their pharmacists into filling prescriptions for opioids and other controlled substances without a thorough review. 

In a statement however, Walgreens said many of the federal rules governing pharmacies are so vague as to be impossible to follow. 

“We are asking the court to clarify the responsibilities of pharmacies and pharmacists and to protect against the government’s attempt to enforce arbitrary ‘rules’ that do not appear in any law or regulation and never went through any official rulemaking process,” Walgreens said. “We will not stand by and allow the government to put our pharmacists in a no-win situation, trying to comply with ‘rules’ that simply do not exist.

“Walgreens stands behind our pharmacists, dedicated healthcare professionals who live in the communities they serve, filling legitimate prescriptions for FDA-approved medications written by DEA-licensed prescribers in accordance with all applicable laws and regulations.”

Both CVS and Walgreens are accused of filling prescriptions for “dangerous and excessive quantities of opioids,” filling prescriptions too early, and filling prescriptions for opioids, benzodiazepines and muscle relaxants, a three-drug combination known as the “Holy Trinity” that the feds consider dangerous.

The DOJ alleges that, from 2012 through the present, Walgreens knowingly filled millions of prescriptions for controlled substances that lacked a “legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice.” The complaint against CVS is nearly identical.

It’s noteworthy that the DOJ claims that both Walgreens and CVS have been filling these prescriptions “through the present,” because when it comes to getting an opioid prescription filled, pain patients find CVS and Walgreens to be the two most difficult pharmacies to work with. 

In 2023, PNN conducted a large survey of nearly 3,000 pain patients, and when respondents were asked which pharmacy chain was the most difficult to get an opioid prescription filled, more than half the patients in our survey selected either Walgreens (30%) or CVS (26%). 

“Every month when I have to get my medication renewed there is always an issue,” explained one patient. “Walgreens always give people a hard time. I've seen many people standing in line and just walk out.” 

“CVS continually gives me a hard time to fill my Rx even though I have been on it for over 7 years. It is either out of stock, or they argue with me about filling it,” another patient told us.

That difficulty is likely tied to the fact that Walgreens and CVS signed the National Opioid Settlement in 2022. As part of the settlement, they agreed to pay more than $10 billion to states, cities and counties that sued them for their alleged roles in causing the opioid epidemic. 

The nation’s two biggest pharmacy chains also agreed to watch for suspicious orders, report any “problematic” prescribers, and to strictly limit the amount of opioid pain medication they can dispense in any given month.

Opioids, in effect, are now being rationed to their customers, yet the DOJ is claiming that both pharmacies continue to fill opioid prescriptions too easily. 

As a pain patient, I use a small local pharmacy specifically to avoid the issues that are common for patients at large pharmacy chains like Walgreens and CVS. However, that alone doesn’t protect me. When the DOJ goes after large pharmacies, the fear trickles down to the smaller ones as well. 

Nearly every month I have some issue getting my prescription filled. They claim they can’t find the prescription in their system, and only “find it” after I go back and forth with them and my doctor on multiple phone calls. Or they claim it’s out of stock, which unfortunately I have no way of checking to see if they’re telling the truth. 

Just yesterday I spent all day trying to get my pain medication refilled because the pharmacist claimed she accidentally deleted it from the system. I had to get my doctor to resend it. 

Dealing with chronic pain is a struggle in and of itself. The last thing pain patients need is another battle to fight at the pharmacy. If Walgreens and CVS are unsuccessful in fighting back against their respective DOJ lawsuits, it’s likely that pain patients will suffer even more as a result. 

Opioid Pain Medication Used Infrequently by NFL Players

By Pat Anson

As many football fans know, the odds of a National Football League player getting injured during a practice or game are high. A concussion, Achilles rupture, ligament tear or musculoskeletal injury can cause a player to miss a game or even an entire season.

Given the pressure to compete and be ready to play, perhaps it’s not surprising then that nearly 70% of NFL players were prescribed a pain medication during the 2021-2022 seasons.

What is surprising is the type of analgesics they were using.

A new study found that only 2.9% of the pain medications used by NFL players were opioids. The vast majority (86%) of medications, both prescribed and over-the-counter, were nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen or diclofenac. Other non-opioids used by players were muscle relaxants, corticosteroids, gabapentin, acetaminophen and migraine medication.  

The study, recently published in Current Sports Medicine Reports, is based on data from a prescription drug monitoring program (PDMP) that was launched by the NFL in 2019 for all players.

“NFL athletes are exposed to very physical contact and to the development of pain during or after games due to injuries. There’s always been a concern from a safety and health perspective about what are they using to treat their pain,” said co-author Kurt Kroenke, MD, a researcher-clinician at the Regenstrief Institute and Indiana University School of Medicine.

“The good news is of all medicines prescribed to league players for pain, opioids account for only 3 percent. Moreover, only 10 percent of NFL athletes received even a single prescription for an opioid during a one-year period. I think there's been much greater attention to what can be done in the training room for NFL athletes for their injuries and pain that doesn't rely on medicines.”

The findings are remarkable, given the long history of opioid use in the NFL. A 2010 survey of retired players found that over half (52%) used prescription opioids during their careers, with 71% of them reporting misuse. Many continued to use opioids after they stopped playing, with 81% of the retired players reporting their chronic pain was moderate to severe.

Hall of Fame quarterback Brett Farve, an iron man who often played through injuries, admitted taking 15 hydrocodone (Vicodin) pills at a time, and even resorted to asking teammates for their pills.

The NFL’s laissez-faire attitude about opioids started to change after 1,800 former players sued the league in 2016, alleging that team doctors routinely disregarded DEA rules about controlled substances and encouraged players to use opioids and anti-inflammatory drugs.  It was not uncommon at the time for a player to get 6-7 pain pills or injections per week.

Injuries are still common in the NFL, but the league watches drug use much more closely. Every NFL player is tested for drugs at least once a year, usually before the season starts. The league also relaxed its policy about marijuana, effectively allowing players to consume cannabis during the off-season. Moderate consumption is tolerated during the season, as long as a player doesn’t have high levels of THC.   

“Professional football is a very physical sport. But anyone who watches professional hockey or NBA basketball or big league soccer and even college and high school sports, realizes how these players also are prone to injuries and pain,” said Kroenke. “I think how we treat pain safely, using opioid pain medications very infrequently, applies across all sports.”

Exclusive: How CDC Will Evaluate the Impact of Its Opioid Guidelines

By Pat Anson

We’ve learned more about a research study the CDC plans to conduct on the impact of its opioid prescribing guideline, which took opioids off the table as a treatment option for millions of Americans suffering from chronic or acute pain. The study was briefly outlined in a public notice published in the Federal Register in October.

It’s been over 8 years since the CDC released its controversial guideline and two years since the agency revised it, after receiving many reports of patient harm, including rapid opioid tapering, withdrawal, poorly treated pain, and suicide.

The agency has released few details on the “mixed-method quasi-experimental design” of the study, the first attempt by the agency to get direct feedback from patients, caregivers and doctors about the guideline’s impact on pain management.

Further details of the study are not coming from the CDC, but from the Office of Management and Budget (OMB), which is evaluating whether the study meets the requirements of the Paperwork Reduction Act, a law that gives OMB broad authority over the collection of data by federal agencies. The CDC’s briefings for the OMB can be found here, here and here.        

“The goal of this research study is to conduct a rigorous, comprehensive evaluation to assess the 2022 CDC Clinical Practice Guideline implementation, uptake, and outcomes. The government will use this information collection to inform CDC efforts and interventions to ensure that Americans have access to safer, effective ways of managing their pain,” the CDC explained.

“We propose conducting an analysis of changes in public and private payers’ policies—e.g., those governing Medicaid, Medicare, private health plans—since late 2022 when the CDC released the Clinical Practice Guideline.”

The study will be conducted over a four-year period and cost nearly $4 million, with much of the work subcontracted to Abt Global, a private research and consulting firm. Abt Global will perform a series of interviews, surveys and focus groups involving patients, caregivers and doctors; as well as dentists, insurers, health system leaders, professional medical associations, and state medical boards.

The DEA and other law enforcement agencies that investigated and prosecuted doctors for “unlawful” opioid prescribing are not included in the study.

The CDC’s previous attempts at evaluating the 2016 and 2022 guidelines relied on data about opioid prescribing rates, not on patient welfare or even whether the guidelines met their primary goal of reducing opioid addiction and overdoses. In that respect, the guidelines have failed. While opioid prescribing has fallen to levels not seen in decades, opioid-related overdoses have nearly doubled since the 2016 guideline’s release.

‘What Has Been Most Effective in Managing Your Pain?’

The CDC is planning an online survey of about 600 doctors (with invitations sent to 3,000) and virtual interviews with 30 of them, asking about their pain management and opioid prescribing practices, as well as any “unintended consequences“ of the agency’s guidelines. Similar questions will be asked of the dentists, insurers, health systems, medical boards, and professional societies.

No interviews or surveys are planned with patients or caregivers. Instead, a series of one-hour focus groups will be conducted involving a total of 135 patients and 90 caregivers, who will receive a $75 gift card as an incentive to participate. The CDC says it will “partner with patient advocacy organizations” to identify participants from their membership lists.

Due to the nature of focus groups, the opinions gathered from patients and caregivers are likely to be viewed as anecdotal or qualitative “perceptions,” not quantitative research.

“We will conduct focus groups with patients to provide an in-depth understanding of a single or small number of cases set in their real-world contexts. Examining the experiences of patients can provide a deeper understanding of real-world behavior within a specific healthcare context to elucidate perceptions of whether and/or how changes occurred in overall treatment and/or pain management, including opioid prescribing,” the CDC said.

The focus groups will be led by Abt Global moderators, who will ask a series of open-ended questions to promote discussion. Notably, there are more questions in the “Patient Focus Group Guide” about non-opioid pain treatments than there are about opioids.

There are also no questions about the CDC’s 2016 guideline. The focus is only on pain management after November 2022, when the revised guideline was released in an attempt to give more flexibility to doctors in using opioids to manage pain.

Focus Group Questions for Patients  

1. What treatments and medications for pain have you tried? What has been most effective in managing your pain?

2. There are a lot of strategies to help with pain. Tell us about your experience with physical therapy or exercise therapy to help with your pain.

3. Counseling or behavioral therapy is often used to help with pain. What has your experience been receiving counseling for pain management?

4. Have you had experience with any other non-medication therapies for pain (e.g., acupuncture)? Can you share your experience with those?

5. Medications other than opioids, such as ibuprofen and acetaminophen, which can be both prescribed or over-the-counter, are also often used for pain management. Tell us your experience with these non-opioid medications to manage your pain.

6. Tell us about your first experience being prescribed opioids for pain. How was your pain after you began taking opioids? What side effects did you experience?

7. When were you initially prescribed opioids for pain? How long were you initially prescribed opioids for? Had you received additional refills for opioids after that first prescription?

8. Have you noticed any changes to how clinicians manage your pain since November 2022? If so, what have you noticed?

9. Give me an example of how the management of your pain has improved since November 2022?

10. Give me an example of how the management of your pain remained the same since November 2022?

11. How has your pain management gotten worse since November 2022?

12. Since November 2022, what other factors may have affected how your pain has been managed, such as a change in primary care clinician or changes in your insurance coverage or changing from a primary care clinician to a pain management specialist?

This kind of detail about the questions, participants and research methods has not been made public before. Only a brief overview of the study was provided in the October 2024 notice in the Federal Register, which the CDC made no effort to publicize to get broad public feedback.

As a result, the notice received only two public comments, one of them a letter from the American Society of Anesthesiologists (ASA). The ASA called the 2022 guideline a “significant improvement” over the 2016 guideline, but added that 40% of its members felt the updated guideline was “ineffective.” There were also criticisms that the guidelines “might lead to reduced access to necessary pain medications.”

The CDC was dismissive of both public comments and said no changes would be made to its study design or methodology.  

“The public comments received did not have specific suggestions that impact any evaluation instruments; therefore, no changes were made to the instruments,” CDC said.      

FDA Approved Genetic Test for Opioid Use Disorder Is Flawed

By Crystal Lindell

An FDA-approved test that claims it can identify genetic risk for opioid use disorder (OUD) is so flawed as to basically be useless – at least according to a new study published in JAMA.

The genetic test, which is sold under the brand name “AvertD” by AutoGenomics, was given approval by the Food and Drug Administration in 2023. The test claims it can use 15 genetic variants to identify people at risk for misusing opioids. 

According to AutoGenomics, the variants “may be associated with an elevated genetic risk for developing OUD.” However, the company provides no citations to support the associations between the brain reward pathways and OUD — meaning the test’s foundation itself seems to be flawed.

However, the authors took the premise of the AvertD test seriously, and set out to find if it could actually predict OUD. They looked at a diverse sample of more than 450,000 “opioid-exposed individuals” (including 33,669 individuals with OUD), and found no evidence to support the use of the AvertD test. 

Specifically, they found both high rates of false positives and false negatives, with 47 out of 100 predicated cases or controls being incorrect. 

“Notably, clinicians could better predict OUD risk using an individual’s age and sex than the 15 genetic variants,” researchers said.

The fact that the test doesn’t seem to work could have dangerous consequences for pain patients. The fear is that they will be used to deny patients opioid medications simply because their “genetic markers” show them to be in a high-risk patient group. 

The study authors directly point this out, writing: “False-positive findings can contribute to stigma, cause patients undue concern, and bias health care decisions.”

They also point out the potential harms of a false-negative finding, which "could give patients and prescribers a false sense of security regarding opioid use and lead to inadequate treatment plans."

The fact that this genetic test has gotten as far as it has raises questions about the FDA approval process. 

The problems don’t stop there though. Another major flaw in both the study and the genetic testing is that “Opioid Use Disorder” has such murky diagnostic criteria, that it’s difficult to take it seriously. It’s basically a set of vague symptoms, as opposed to a clear-cut diagnosis, despite what some have been led to believe. 

A CDC fact sheet for OUD Diagnostic Criteria is a mishmash of vague symptoms, such as tolerance and withdrawal, that could just be the result of untreated or poorly treated physical pain. 

Things like “taking opioids in larger amounts or over a longer period of time than intended” and “having a persistent desire or unsuccessful attempts to reduce or control opioid use.”

The CDC also lists "withdrawal symptoms" as one of the diagnostic criteria for OUD, which is something that people can experience from rapid tapering without having OUD.

The CDC then includes the odd disclaimer that “tolerance and withdrawal are not considered” when opioids are taken under appropriate medical supervision.

So in a country that does not guarantee healthcare, you can avoid an OUD diagnosis if you can afford to find a doctor willing to prescribe opioids to you. But if you can’t find a doctor or abandoned by one — and then have withdrawal symptoms — you must have a disorder.

That doesn’t sound like a medical diagnosis to me. That sounds like classism.

A patient needs just to have just two of the OUD criteria to have “mild OUD” – a benchmark that has the sweeping effect of including a large number of patients taking opioids for chronic pain. 

It’s no wonder that a genetic test claiming to be able to predict OUD would be so flawed, given how flawed the diagnosis of OUD is to begin with. 

Perhaps instead of trying to guess potential risks for a vague disorder, the FDA should be focused on treatments already proven effective for people who want to stop their opioid use, like expanding methadone access. 

The whole situation reminds me of the Tom Cruise-movie Minority Report, a futuristic thriller in which a specialized police department called Precrime “apprehends criminals by use of foreknowledge provided by three psychics.”

Denying people pain medication based on a flawed genetic test that falsely claims it can predict the future is basically the same thing. And it’s just as evil in real life as it is in the movie.  

Chronic Pain Leading Risk Factor for Suicide by U.S. Veterans

By Pat Anson

Chronic pain is the leading risk factor for suicide by U.S. veterans, according to a comprehensive new report by the Department of Veterans Affairs that also identified poor sleep, declining physical activity, and other health problems that significantly raise the risk of a veteran dying by suicide.

VA researchers estimate there were over 6,400 veteran suicides in 2022, an average of 17.6 suicides per day. The suicide rate for veterans (34.7 per 100,000) is twice the rate among non-veterans (17.1 per 100,000).

While those are alarming figures, there are some signs of progress. The number of veteran suicides has been trending downward since 2018, with a notable decline in the suicide rate among female veterans (-24.1%), homeless veterans (-19.1%) and younger veterans (-3.8%) in 2022.

Dept. of Veterans Affairs

The VA report goes into great detail on the methods used to commit suicide (a firearm is the most likely), and whether a deceased veteran had social, financial, mental health, or substance abuse problems.

But surprisingly little attention is paid to the leading risk factor: chronic pain. Only on Page 44 of the report is it disclosed that 53.8% of veterans who died by suicide reported pain in the year prior to their death. Pain isn’t even mentioned in a VA news release on the report.

“Every veteran suicide is a tragedy,” said Secretary of Veterans Affairs Denis McDonough in that news release. “There is nothing more important to VA than ending veteran suicide — and that means providing veterans with the care they need, wherever they need it, whenever they need it.”

‘The Pain Is Forever’

Many veterans in pain say they can’t get the care they need in the VA health system, which has worked to reduce opioid prescribing and expand the use of non-opioid alternatives. The VA updated its clinical practice guideline in 2022 to strongly recommend against long-term opioid therapy, especially for younger veterans.

“The VA makes you go through re-education camp for pain meds for chronic pain for injuries and diseases,” one veteran told us. “They make doctors refuse to prescribe pain meds and they made a whole new industry punishing sick people. Anyone who joins the military should know the hell they will be put through if they are injured and the pain is forever.”

“It's amazing how VA loves to play with my treatment for chronic pain. If I get tapered down again (for the 5th time) I don't know what I will do. It makes the heroin option look like the best way to go,” said another veteran. “And they can't understand why so many vets are killing themselves.”

“Chronic pain is known to be both common amongst individuals who die by suicide and a frequent issue identified as a reason for ending one’s life,” says Anne Fuqua, a chronic pain sufferer who has been tracking pain patient suicides for several years.

“If VA claims preventing suicide is a top clinical priority, when chronic pain is present, they should treat it aggressively, employing whatever medications and interventions are needed to best treat an individual without being handicapped by artificial limits that have no relationship to the individual veteran’s clinical situation.”

More Research Needed

Risk factors that contribute to suicide are difficult to measure, largely due to the difficulty of assessing possible causes for a veteran who has passed away and can’t speak for themselves. Suicide is often a taboo topic for a veteran’s surviving family and loved ones.

One expert says the VA deserves credit for trying to tackle such a complex problem.    

“We have to demand that every health care system, not just the VA, recognize the special risk to suicide that occurs in people who have all of these risk factors, whether it’s sleep, impulsivity, an unsecured firearm, or pain,” said Stefan Kertesz, MD, an internist at the Birmingham VA Medical Center and Professor of Medicine at the University of Alabama at Birmingham.

“In many health care settings, efforts to quantify the pain experience have been made taboo. That's a horrible mistake. Not asking about something doesn't make the problem go away.” 

Kertesz is leading a study of suicides among veterans and civilians, and is trying to connect with survivors who can talk about changes in healthcare and social functioning that occurred prior to a loved one’s death.

“We need to ask, carefully and systematically, about what is going on in the lives of folks who are in distress. We need to ask how we can be of help,” said Kertesz.

“The prominence of pain in the VA’s statistical report does not mean pain is the primary driver of suicide. Most folks with pain, after all, don’t consider suicide. But it is a reminder that we can’t ignore pain or minimize it or pawn it off on the patient as their little problem to solve. We need to be present and we need to ask, relentlessly, what the heck is going wrong and how can we do better?”

If you have lost someone with pain to suicide, you can learn more about the study by clicking here or on the banner below. Participants who are interviewed may be eligible for a cash payment of $100.

How Do We Decide Which Drugs Are Bad and Which Ones Are Good?

By Crystal Lindell

I was in elementary school during the height of the original DARE campaign. I vividly remember fully uniformed police officers coming into my classrooms to share the Drug Abuse Resistance Education’s program’s very direct message: “DARE to say no to drugs!”

My friends and I all got free black T-shirts with the bold red DARE slogan splashed across it, and every year we signed a pledge promising to never use drugs.  

What qualified something as a “drug” was a little more difficult to discern though. 

Back in the 1990s there was a lot of talk about “pot” and “dope,” so I figured those were both bad, although as a 10-year-old living in a pre-Google world, I didn’t really know what either one was and I didn’t know how to find out.

I also remember lots of conversations about alcohol and cigarettes, but those were apparently only “drugs” if you were under a certain age, seeing as how a lot of adults I knew used them. 

How effective DARE was is still hotly debated, but there is one part that seems to have left a lasting legacy: Most Americans still think anything labeled as a “drug” by cops is inherently bad and must therefore be greatly restricted and regulated.  

Now that I’m in my 40s, I am much less accepting of the blanket “drugs are bad” messages that law enforcement agencies spread to my peers and me back in the day. 

As it turns out, “drugs” can mean a lot of things, and the reasons we are given for why some are bad and some are good are murky at best. 

If you ask most adults in the United States to define “drugs,” they’ll often reach for whatever legal categories the police have neatly provided. Opioids and stimulants are “drugs” because they are heavily regulated, but NSAIDS and acetaminophen aren’t because you can buy them over the counter at Walgreens. 

If you push them to consider the definition beyond what law enforcement has provided, they’ll usually go right to “things that are addictive.” If you point out that caffeine is extremely addictive though, they’ll shrug that off with “well that’s different.” 

I’ll also often hear people defend their morning latte with something along the lines of “well nobody’s ever resorted to sex work to buy an espresso," as though that in and of itself makes coffee superior to a morning Adderall. 

Aside from the fact that this logic shames sex workers, it also leaves out the very important reason that people don’t have to resort to extremes to access coffee: Caffeine is legally sold over the counter. 

If medications like hydrocodone or Adderall were sold in the same way as your morning coffee, they would also be cheap, safe and easily available – and thus people wouldn’t have to resort to extremes to be able to afford them. 

Beyond that, we also have decided, as a culture, that lots of very addictive things should be sold over the counter. 

In addition to coffee, adults can purchase alcohol and nicotine with no problem, despite how deadly both of those are. What makes them different from Adderall or even Oxycontin? Have you ever really considered the question? 

If anything, don't drunk driving and second-hand smoke potentially make alcohol and nicotine worse, since there’s so much danger to non-users?

Personally, as a pain patient who has also seen many loved ones suffer as a result of an onslaught of opioid-phobic regulations over the last decade, I will admit to having been radicalized on this issue. 

I think most of the drug laws we have on the books are far too restrictive, and most substances should be sold the same way alcohol and coffee are: Over the counter. 

However, I can appreciate the fact that this is a radical position in the United States. After all, we’ve all been subjected to heavy anti-drug propaganda for decades now, going back to Nancy Reagan first telling kids to “Just Say No” way back in 1982. 

I’d encourage you to think critically about such a simplistic slogan though. When it comes to which substances people want to consume and why, it’s not quite so easy to know when a drug is bad and when it’s good. 

In fact, I have a saying of my own that I like to share during conversations about drug legalization. I believe people use the drugs they need and, absent that, they’ll use the drugs they have access to.

So if a drug is something you need, is it really something you should “Just say no” to?

The Most Popular Pain News Network Stories of 2024

By Crystal Lindell

Looking back at 2024, there was a lot of news to cover about chronic pain and illness. Access to opioids and new pain treatments were two issues that readers were most interested in over the last year. 

Below is a look at the top 6 most widely read articles that PNN published in 2024, a year that saw us reach nearly 550,000 readers around the world.

Kamala Harris’ Stepdaughter Draws Backlash for Advocating Pain Treatments

Our most widely read article — by far — discussed Ella Emhoff, the 25-year old stepdaughter of Vice President Kamala Harris, who was running for president at the time. 

Emhoff revealed on social media that she has chronic back pain and shared a list of ways that she tries to address it, including alternative treatments such as ketamine, exercise, and an anti-inflammatory diet. 

Emhoff’s lengthy list of potential treatments got some push back from our readers, in part because she never mentions opioids. Other readers were hopeful that Emhoff could help draw more attention to an issue that most politicians ignore.

“How much her stepmom is aware of her stepdaughter's trials & tribulations is an unknown, but there is a tiny ray of hope that she - the candidate - has at least some direct awareness of an issue that effects millions of Americans but remains unaddressed by anyone,” one reader commented.

Read the full article here.

New Mothers Lose Custody of Babies After False Positive Drug Tests

This article was about hospitals routinely giving urine drug tests to new moms — and then reporting them to child welfare agencies when the tests show false positives. One mother wasn’t allowed to take her newborn baby home because she ate a salad with poppy seeds and then falsely tested positive for codeine.

The article was based on an investigation by The Marshall Project, which interviewed dozens of mothers, medical providers, toxicologists and other experts to report the story. 

“People should be concerned,” Dr. Stephen Patrick, a neonatal researcher told The Marshall Project. “This could happen to any one of us.”

Read the full article here. 

DEA Finalizes More Cuts in Opioid Supply

For the 8th consecutive year, the U.S. Drug Enforcement Administration reduced the amount of opioid pain medication that drug makers can produce in 2024, ignoring complaints from thousands of patients that opioids are already difficult to obtain and many pharmacies are out of stock.

This article received more reader comments than any other in 2024.

“This is absolutely criminal, the DEA dictating how much painkillers are available? How much more do legitimate chronic pain sufferers need to suffer? Now I know why I couldn’t get my pain medication. This really pisses me off and it should piss off everybody!” one reader posted.

Read the full article here.

Many Doctors Hesitant to Accept Patients Using Opioids or Cannabis

This article delved into research at the University of Michigan showing that many primary care doctors are reluctant to accept new patients who use either opioids or cannabis.

Of the 852 physicians surveyed, nearly a third (32%) said they would not accept a patient using opioids daily, while 18% felt the same way about patients using medical cannabis.

“This lack of access could inadvertently encourage patients to seek nonmedical treatments for their chronic pain, given that relief of pain is the most commonly reported reason for misuse of controlled substances,” said lead author Mark Bicket, MD.

Read the full article here.

90% of Pain Patients Have Trouble Filling Opioid Prescriptions

This article looked at the results of a PNN survey of over 2,800 patients with an opioid prescription. 

We found that nine out of ten patients experienced delays or problems getting their prescription filled at a U.S. pharmacy. Even after contacting multiple pharmacies, nearly 20% were unable to get their prescription filled,

“My medication helps my pain be at a level I can tolerate. When I can't get it, I honestly feel like ending my life due to the pain. I wish they'd stop to realize there are those of us with a legitimate need,” one patient told us.

Read the full article here

‘Smart Opioid’ Relieves Pain with Lower Risk of Overdose

This article was about an experimental form of hydrocodone that relieves acute pain without the risks of traditional opioids. 

An early stage clinical trial by Elysium Therapeutics found that its “SMART” formulation of hydrocodone releases therapeutic levels of the pain medication when exposed to a digestive enzyme in the small intestine.

If a patient takes too high of a dose, the drug inhibits production of the enzyme, which slows the release of hydrocodone. In theory, that will reduce the risk of abuse and overdose. 

“I wonder how soon this might be available to the public by prescription? Our country desperately needs more pain control options,” said one reader.

Read the full article here.

We hope you enjoyed reading PNN in 2024 and found our stories informative and helpful. We look forward to continuing our coverage of chronic pain and other health issues in 2025. 

Unlike many other online news outlets, we don’t hide behind a paywall or charge for subscriptions. Pain News Network depends on reader donations to continue publishing, so please consider making a tax deductible donation to PNN today.

Can you chip in just $10, $25 or $50 to help keep our website and newsletter free for everyone?

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.”

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, 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.

‘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.

More Lackluster Results for Non-Opioid Pain Reliever

By Pat Anson

New questions are being raised about the effectiveness of an experimental non-opioid analgesic and whether it can be a viable alternative to opioid pain medication.

Results from Vertex Pharmaceuticals’ Phase 2 clinical trial show that suzetrigine is essentially no more effective than a placebo in relieving back and hip pain caused by lumbosacral radiculopathy (LSR).

After 12 weeks of treatment with the drug suzetrigine, patients with LSR had a 2.02 average reduction in their pain scores on a rating scale of zero to 10. That compares to an average reduction of 1.98 for patients who received a placebo or sham treatment.

Although the difference between 2.02 and 1.98 is minuscule, Vertex claimed the overall findings were “statistically significant and clinically meaningful” in a press release. The company blamed the lackluster results on the placebo effect and the difficulty of treating lumbosacral radiculopathy.

“Suzetrigine has again demonstrated its potential to fill an important unmet need in the treatment of pain,” said Carmen Bozic, MD, Executive Vice President and Chief Medical Officer at Vertex. “We did not see separation between the suzetrigine and the placebo arms. Yet our post-hoc analyses suggest that this could be due to the high placebo response in this study.”

Despite the disappointing results, Vertex still plans to go ahead with a Phase 3 study of suzetrigine for LSR, while changing the study design to minimize the impact of the placebo.

“Managing the placebo response in pain trials is a complex challenge. We look forward to innovating in clinical trial design, including for the pivotal study, with the aim of bringing a potentially safe and effective treatment to patients suffering from LSR," said Christine Sang, MD, co-chair of Vertex’s Peripheral Neuropathic Pain steering committee and principal investigator of the study.

Suzetrigine is already under consideration by the FDA as a treatment for acute pain, with a decision expected in late January. If approved, suzetrigine would be the first new medication for acute pain in over two decades.

Unlike opioids, suzetrigine blocks pain signals in the peripheral nervous system before they reach the brain. That means it won’t have the “liking” effect that opioids can have in some patients or be as addictive.

Although suzetrigine has been touted as a novel painkiller that "could bring relief to millions” without the risk of addiction, findings from earlier studies have also been mixed. In a Phase 3 trial of patients recovering from minimally invasive surgery, suzetrigine was no more effective than a low dose combination of hydrocodone and acetaminophen, more commonly known as Vicodin.

Although Vertex downplayed the results from the Phase 2 study, shares of the company lost about 15% of their value after last week’s announcement. Wall Street analysts said the Phase 2 findings were “very messy” and "raise considerable risk around suzetrigine's potential.”

Ultimately, it will be up to the FDA to decide whether suzetrigine should be allowed on the market. The agency is under pressure to approve new non-opioid analgesics, so it may look past the disappointing clinical trial findings. If approval is granted in January, it will coincide with implementation of the NOPAIN Act, which will make non-opioid analgesics in outpatient surgical settings eligible for higher Medicare reimbursement rates.  

In addition to acute pain and lumbosacral radiculopathy, Vertex is also studying suzetrigine as a treatment for diabetic peripheral neuropathy.

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. 

Anthem Blue Cross Blue Shield Under Fire for Limits in Anesthesia Coverage

By Pat Anson

One of the nation’s largest health insurers is under fire for making plans to cutoff coverage of anesthesia care if a surgery or procedure lasts too long. The criticism was so widespread, Anthem Blue Cross Blue Shield reversed course and said it would not implement the policy.

In early November, Anthem said it will not allow anesthesiologists to bill for services that exceed time frame standards adopted by the Centers for Medicare and Medicaid Services (CMS). The only exceptions were for patients under the age of 22 and for maternity-related care.

Anthem’s policy would have applied to hundreds of procedures on specific body areas, including the head, neck, spine, leg and elbow. The anesthesia services covered include general anesthesia, when a patient is kept unconscious during a major operation, as well as local and regional anesthesia, which would include epidurals, nerve blocks and injections that numb selected areas.

“We will utilize the CMS Physician Work Time values to target the number of minutes reported for anesthesia services. Claims submitted with reported time above the established number of minutes will be denied,” Anthem said in a notice sent to providers in New York state.

The proposed policy covered to all anesthesia care that occurs before, during and after surgery – meaning the clock would start ticking the minute an anesthesiologist goes to work.

“Ridiculous. Does Anthem expect a patient to get up in the middle of a surgery and walk away?” New York State Sen. Mike Gianaris tweeted.

“As someone who has had 10 surgeries in the last 17 years, I have NEVER had a surgery end sooner than the estimated time. What Anthem Blue Cross Blue Shield is proposing is MONSTROUS,” patient advocate Peter Morley posted on Bluesky. “Fortunately I have Medicare but don’t think this doesn’t weigh heavily on me and others preparing for surgery now & in the future. How many will cancel their surgeries because of this?”

In addition to New York, Anthem also sent notices about the policy change to providers in Connecticut, Missouri and Colorado. It’s not clear if other states would be affected.

“This is just the latest in a long line of appalling behavior by commercial health insurers looking to drive their profits up at the expense of patients and physicians providing essential care,” Donald Arnold, MD, President of the American Society of Anesthesiologists (ASA), said in a statement.

“It’s a cynical money grab by Anthem, designed to take advantage of the commitment anesthesiologists make thousands of times each day to provide their patients with expert, complete and safe anesthesia care. This egregious policy breaks the trust between Anthem and its policyholders who expect their health insurer to pay physicians for the entirety of the care they need.”

The ASA urged people opposed to Anthem’s plan to contact their state insurance commissioner or state legislators.

Although Anthem’s policy was announced over a month ago, it only recently started attracting public attention and outrage.

“This is appalling. Saddling patients with thousands of dollars in surprise additional medical debt. And for what? Just to boost corporate profits?” tweeted Sen. Chris Murphy of Connecticut.  

In response to the backlash, Anthem released a new statement today claiming it was all a misunderstanding.

“There has been significant widespread misinformation about an update to our anesthesia policy. As a result, we have decided to not proceed with this policy change,” the company said. “To be clear, it never was and never will be the policy of Anthem Blue Cross Blue Shield to not pay for medically necessary anesthesia services. The proposed update to the policy was only designed to clarify the appropriateness of anesthesia consistent with well-established clinical guidelines.”

Elevance Health, the parent company of Anthem, recently reported operating revenue of $44.7 billion in the third quarter of 2024, an increase of $2.2 billion from the same period a year ago. Elevance provides insurance, pharmacy and medical services to about 113 million consumers.