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.      

How Vaccine Misinformation Distorts Science

By Mark O'Brian

Vaccinations provide significant protection for the public against infectious diseases and substantially reduce health care costs. Therefore, it is noteworthy that President-elect Donald Trump wants Robert F. Kennedy Jr., a leading critic of childhood vaccination, to be secretary of Health and Human Services.

Doctors, scientists and public health researchers have expressed concerns that Kennedy would turn his views into policies that could undermine public health. As a case in point, news reports have highlighted how Kennedy’s lawyer, Aaron Siri, has in recent years petitioned the Food and Drug Administration to withdraw or suspend approval of numerous vaccines over alleged safety concerns.

I am a biochemist and molecular biologist studying the roles microbes play in health and disease. I also teach medical students and am interested in how the public understands science.

Here are some facts about vaccines that Kennedy and Siri get wrong:

Vaccines Don’t Cause Autism

Public health data from 1974 to the present conclude that vaccines have saved at least 154 million lives worldwide over the past 50 years. Vaccines are also continually monitored for safety in the U.S.

Nevertheless, the false claim that vaccines cause autism persists despite study after study of large populations throughout the world showing no causal link between them.

Claims about the dangers of vaccines often come from misrepresenting scientific research papers. In an interview with podcaster Joe Rogan, Kennedy incorrectly cited studies allegedly showing vaccines cause massive brain inflammation in laboratory monkeys, and that the hepatitis B vaccine increases autism rates in children by over 1,000-fold compared with unvaccinated kids. Those studies make no such claims.

In the same interview, Kennedy also made the unusual claim that a 2002 vaccine study included a control group of children 6 months of age and younger who were fed mercury-contaminated tuna sandwiches. No sandwiches are mentioned in that study.

Similarly, Siri filed a petition in 2022 to withdraw approval of a polio vaccine based on alleged safety concerns. The vaccine in question is made from an inactivated form of the polio virus, which is safer than the previously used live attenuated vaccine.

The inactivated vaccine is made from polio virus cultured in the Vero cell line, a type of cell that researchers have been safely using for various medical applications since 1962. While the petition uses provocative language comparing this cell line to cancer cells, it does not claim that it causes cancer.

Vaccines Undergo Clinical Trials

Clinical trials for vaccines and other drugs are blinded, randomized and placebo-controlled studies. For a vaccine trial, this means that participants are randomly divided into one group that receives the vaccine and a second group that receives a placebo saline solution. The researchers carrying out the study, and sometimes the participants themselves, do not know who has received the vaccine or the placebo until the study has finished. This eliminates bias.

Results are published in the public domain. For example, vaccine trial data for COVID-19, human papilloma virus, rotavirus and hepatitis B are available for anyone to access.

Aluminum Boosts Immunity

Kennedy is co-counsel with a law firm that is suing the pharmaceutical company Merck based in part on the unfounded assertion that the aluminum in one of its vaccines causes neurological disease. Aluminum is added to many vaccines as an adjuvant to strengthen the body’s immune response to the vaccine, thereby enhancing the body’s defense against the targeted microbe.

The law firm’s claim is based on a 2020 report showing that brain tissue from some patients with Alzheimer’s disease, autism and multiple sclerosis have elevated levels of aluminum. The authors of that study do not assert that vaccines are the source of the aluminum, and vaccines are unlikely to be the culprit.

Notably, the brain samples analyzed in that study were from 47- to 105-year-old patients. Most people are exposed to aluminum primarily through their diets, and aluminum is eliminated from the body within days. Therefore, aluminum exposure from childhood vaccines is not expected to persist in those patients.

Ironically, Kennedy’s lawyer, Siri, wants the FDA to withdraw some vaccines for containing less aluminum than stated by the manufacturer.

Vaccine Manufacturers Can Be Held Liable

Kennedy’s lawsuit against Merck contradicts his insistence that vaccine manufacturers are fully immune from litigation.

His claim is based on an incorrect interpretation of the National Vaccine Injury Compensation Program, or VICP. The VICP is a no-fault federal program created to reduce frivolous lawsuits against vaccine manufacturers, which threaten to cause vaccine shortages and a resurgence of vaccine-preventable disease.

A person claiming injury from a vaccine can petition the U.S. Court of Federal Claims through the VICP for monetary compensation. If the VICP petition is denied, the claimant can then sue the vaccine manufacturer.

The majority of cases resolved under the VICP end in a negotiated settlement between parties without establishing that a vaccine was the cause of the claimed injury. Kennedy and his law firm have incorrectly used the payouts under the VICP to assert that vaccines are unsafe.

The VICP gets the vaccine manufacturer off the hook only if it has complied with all requirements of the Federal Food, Drug and Cosmetic Act and exercised due care. It does not protect the vaccine maker from claims of fraud or withholding information regarding the safety or efficacy of the vaccine during its development or after approval.

Good Nutrition Is Not a Substitute for Vaccination

Kennedy asserts that populations with adequate nutrition do not need vaccines to avoid infectious diseases. While it is clear that improvements in nutrition, sanitation, water treatment, food safety and public health measures have played important roles in reducing deaths and severe complications from infectious diseases, these factors do not eliminate the need for vaccines.

After World War II, the U.S. was a wealthy nation with substantial health-related infrastructure. Yet, Americans reported an average of 1 million cases per year of now-preventable infectious diseases.

Vaccines introduced or expanded in the 1950s and 1960s against diseases like diphtheria, pertussis, tetanus, measles, polio, mumps, rubella and Haemophilus influenza B have resulted in the near or complete eradication of those diseases.

It’s easy to forget why many infectious diseases are rarely encountered today: The success of vaccines does not always tell its own story. RFK Jr.’s potential ascent to the role of secretary of Health and Human Services will offer up ample opportunities to retell this story and counter misinformation.

Mark R. O'Brian, PhD, is a Professor and Chair of Biochemistry at the University at Buffalo. His research is focused on understanding how microbes regulate cellular processes relevant to agriculture, human health and disease.

This article originally appeared in The Conversation and is republished with permission.

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.  

Got Colostrum? The Good and Bad About Bovine Milk Supplements

By Manal Mohammed

From Kourtney Kardashian Barker to Gwyneth Paltrow, wellness celebrities are extolling the benefits of taking bovine colostrum supplements. Social media influencer Sofia Richie Grainge has even launched her own bovine colostrum-laced smoothie.

The supplement, they claim, offers a wide range of health benefits, including glowing skin with increased elasticity. Some brands claim that consuming bovine colostrum can protect adult humans from cold, cough and sickness bugs, improve gut health and support weight loss.

Bovine colostrum is also popular among some athletes who claim it can help improve exercise performance, build strength and speed up recovery.

I’m no stranger to the benefits of animal colostrum – before I joined academia I worked as a veterinarian. I witnessed that newborn animals who did not receive colostrum just after birth were at a significantly increased risk of death and disease. I was emphatic to my clients, then, about the crucial role of colostrum in the early development of newborn animals, as well as their overall health later in life.

But is cow colostrum a miracle health elixir or just the latest wellness fad?

Nature’s First Vaccine

There’s no doubt that colostrum is wonderful stuff. Known as “nature’s first vaccine”, colostrum is the first milk produced by the breast of female mammals in the two to five days immediately after giving birth. It is a nutrient dense liquid rich in antibodies, antioxidants, growth factors, vitamins, minerals and nutrients that boost newborns’ immune systems and support their overall growth.

In humans, colostrum should be given to newborns as soon after birth as possible, preferably within the first hour of birth and repeated at no later than six hours after birth. Colostrum is perfectly balanced for all baby’s needs. But there is not enough rigorous scientific evidence on human colostrum’s benefits for adults.

There is, though, some evidence to suggest that bovine colostrum may help humans to fight infection, improve gut health, relieve stomach and digestive issues, reduce inflammation and lower risk of catching the flu and upper respiratory infections.

But its efficacy depends on the product: how it’s processed, manufactured and stored – and the product’s potency. Bovine colostrum supplements aren’t regulated in the same way as drugs so there’s currently no guarantee of consistent quality.

Bovine colostrum contains higher total protein content than mature milk, mainly due to higher levels of antibodies (also known as immunoglobulins) and casein – a protein that supports muscle building. As well as immune-regulatory, antibacterial and anti-inflammatory properties, milk casein may offer a number of metabolic and protective benefits for humans.

For example, it can help to reduce appetite because it’s digested more slowly than other proteins. Research suggests that consuming casein before bed may increase metabolic rate and the protein has also been associated with improvement in brain function because of its protective effects on the nervous system.

The level of antibodies in bovine colostrum can be 100 times higher than levels in regular cow’s milk. Hyperimmune bovine colostrum is made by cows that have been vaccinated for diseases such as rotavirus. These cows produce antibodies that can help fight viruses and bacteria that cause disease and infection.

And that’s not all. Bovine colostrum also contains antimicrobials, which kill bacteria, viruses, fungi and parasites. Studies have also shown that these antimicrobials can help prevent common gastrointestinal infections, such as Escherichia coli, Salmonella and Helicobacter pylori. They can also act as prebiotics by stimulating growth of beneficial bacteria in the gut.

As if that isn’t enough, studies also report that taking blood colostrum supplements may help reduce flu-like episodes and upper respiratory tract infections. A 2006 study even suggested that taking bovine colostrum might help reduce diarrhoea in people with HIV/AIDS.

Miracle Milk or Frivolous Fad?

Taking bovine colostrum might sound appealing – but if you’re thinking of buying one of the expensive products on the market, bear in mind the lack of regulation and the scarcity of rigorous data on the safety and risks of the supplements.

What we do know is that people with a cow’s milk allergy should not ingest or apply bovine colostrum. Any use of bovine colostrum could result in severe side effects. In 2019 a 16-year-old boy with an allergy to cow’s milk developed anaphylaxis after a bovine colostrum-based cream was applied to a surgical wound. Even those who aren’t allergic to cow’s milk could suffer mild gastrointestinal discomfort, such as nausea and gas, while taking a bovine colostrum supplement.

So, it’s possible that bovine colostrum might offer some health benefits but the lack of product regulation and research makes buying supplements an expensive gamble. Having a healthy lifestyle with a good diet and regular exercise would undoubtedly be a much safer bet for your health – and your bank balance.

Manal Mohammed, PhD, is a Senior Lecturer of Medical Microbiology at the University of Westminster. Her research and teaching focus on infectious diseases, their diagnosis, prevention and treatment.

This article originally appeared in The Conversation and is republished with permission.

Why Life With Chronic Pain Makes Every New Ache Extra Terrifying

By Crystal Lindell

Late Sunday night, while putting freshly cleaned sheets onto my bed, I twisted a little weird and threw out my back.

By Monday morning, the pain was so debilitating that I was sobbing as my fiancé tried to help me out of our bed. But beyond dealing with the immediate physical pain, I was also terrified of the future.

As a chronic pain patient, every time I get any new illness or affliction I worry that it will become what the rib pain I woke up with in 2013 became: Permanent. 

When you develop chronic health issues of any sort, you lose one of the healthy population’s greatest luxuries: The ability to assume that you’ll eventually get better. 

Thankfully, I seem to be recovering from this flare up of back pain. Three days after the initial onset, I’m able to lift myself out of bed, and even do some light cooking in the kitchen. 

This is the first time I’ve ever experienced any type of severe back pain like this though, and I had been very stressed that my back would never recover.

This isn’t the first time I’ve faced this fear. 

When I had a bad case of COVID in 2022, I spent the first few nights awake with the most severe cold-related muscle aches I’d ever experienced.

In my fever state, I frantically Googled to see if this was a symptom that could become permanent. I was petrified that my body was just broken like this forever. Thankfully it wasn’t, but I know all too well that there’s no guarantee of recovery when it comes to the human body.

It’s not just my health I worry about either. 

Anytime a loved one tells me about a chest cold, some new joint pain, or any type of new health issue, I panic that their body will never recover. Or worse, what if it kills them?

This fear has only been made worse since 2020, when COVID, which first presents as cold symptoms, started spreading. In the years since it has killed multiple people I knew. 

Now anytime anyone I know develops so much as a sore throat, I worry that they’re going to die.

I keep this to myself because there’s nothing to be gained by spreading my worry to them, but I worry nonetheless. I know firsthand how fragile our bodies are, how delicate our health truly is. I am all too aware of the fact that any of us can lose it at any time. 

As I've been enduring the new back pain all week, cursing myself for taking my ability to bend over for granted, I’ve thought a lot about my late-father, who died from COVID in 2022. 

I have vivid memories of him throwing his back multiple times throughout my childhood. Now that it has happened to me, I’ve realized that I didn’t spend nearly enough time asking him how he coped with it, and then seemingly got past it. 

My dad’s back was so bad that he was walking with a cane at age 35, when my younger brother was born in 1989. But the cane was gone within a few years and I don’t remember him needing it again after that. 

Talking with my brother this week, he told me our dad blamed his back pain on driving a truck for a living, a profession he eventually gave up so he could pursue computer programming. So, I assume it was the career change that alleviated his back pain. But now that he’s dead, I’ll never really know for sure how he healed his back, or if he even really did.

My late-grandfather on my mother’s side also spent decades of his life battling seemingly untreatable back pain. He passed away when I was a toddler, but stories about his back pain continued long past his death. 

Now, as an adult, I suspect he was one of the links in the genetic Ehlers-Danlos chain that we now know runs along my mom’s side of the family. We both battled the same condition, but he’ll never know that.

Pain is always bad, but as our bodies age in the same ways our parents, and their parents before them have, it does have one small, silver lining: It can help us connect to our ancestors in new ways, helping us more fully grasp the lives they lived before us. 

After battling this back pain flare up this week, I have a new appreciation for how much pain my dad and my grandfather must have endured due to their back problems, and a more fully developed sense of empathy for their troubles. 

So while I will continue to worry that every new health issue will become permanent, including my new back pain, I can take small comfort in knowing that even if that’s the case, enduring it just makes me part of a long line of my ancestors who’ve endured the same before me. 

Human beings suffer, but when we suffer together, it does tend to alleviate our sorrows ever so slightly. 

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.

Hypnosis Can Help With Pain, Depression, Sleep and PTSD

By David Acunzo

We’ve all seen it, typically on television or on stage: A hypnotist selects a few members from the audience, and with what seems to be little more than a steely stare or a few choice words, they’re suddenly “under the spell.” Depending on what the hypnotist suggests, the participants laugh, dance and perform without inhibition.

Or perhaps you’ve experienced hypnosis another way – with a trip to a hypnotherapist for a series of sessions to help you stop smoking, lose weight, manage pain or deal with depression. This is no longer unusual; thousands of Americans have done the same thing. And many were helped.

Hypnosis has been found to be effective for treating irritable bowel syndrome, and it may be beneficial for weight reduction, sleep disorders and anxiety. For mild to moderate depression in adults, hypnotherapy is as effective as cognitive behavioral therapy, and it can help with depression in children. Hypnosis is also used to treat phobias, PTSD and to control pain during surgery and dental procedures in both adults and children.

Yet despite the evidence, its widespread use and its growing popularity, hypnosis is still viewed with skepticism by some scientists, and with curiosity by much of the public. As a researcher studying altered states from a cognitive and neuroscientific perspective, I’m happy to help pull back the curtain to show you how hypnosis works.

A Hypnotherapy Session

In simple terms, hypnosis is a procedure that helps people imagine different experiences that feel very real. When that occurs, the person can be said to be in a state of hypnosis.

Little is known about what characterizes a hypnotic state in terms of brain activity, but neuroimaging studies indicate a decrease in activity in the parts of the brain responsible for self-referential thought and daydreaming, and increased links between the parts responsible for attention and action.

These results are consistent with the idea that people who are hypnotized are in a state that inhibits internal thoughts and other distractions, such as bodily sensations or noises, that may interfere with the hypnosis.

A therapist’s first set of suggestions typically includes the “hypnotic induction,” which helps the subject increase their responsiveness to other suggestions. An induction may be like this: “I will now count from 5 to 1. At every count, you will feel even more relaxed, and that you are going deeper and deeper into hypnosis.”

When responding to suggestions, the subject’s experience feels involuntary. That is, it’s happening to them, rather than generated by them. This is known as the classical suggestion effect. Following a suggestion to move their arm, the subject may feel as though their arm rises on its own, rather than being raised of their own volition.

For perceptual suggestions, the experience can feel quite real and distinct from voluntary imagination. If I ask you to imagine hearing a dog barking outside, it requires an effort, and the experience does not feel like there’s really a dog barking outside. But through hypnotic suggestion, responsive subjects will feel like they hear a dog barking, and they won’t be cognizant of any effort to make it happen.

What Makes People Hypnotizable?

You can’t force anyone to be hypnotized. Willingness to participate, a positive attitude, motivation and expectation are hugely important. So is the ability to set aside the fact that the situation is imaginative. It’s like when you become fully absorbed with the story and characters in a movie – so absorbed you forget you’re in a theater.

Good rapport with the therapist is also critical. If you refuse to cooperate or decide hypnosis won’t work, it won’t. A good comparison may be meditation: You can listen to a meditation recording, but if you’re unwilling to follow the instructions, or if you’re unmotivated or distracted, it won’t have any effect.

Few traits predict whether someone is easily hypnotizable, but people are not equal in their ability to respond to hypnotic suggestions. Some people vividly experience a wide array of suggestions; others, not nearly as much. There are indications that women respond slightly better to hypnotic suggestions than men, and that peak hypnotizability occurs during late childhood and early teenage years.

From a neuroscientific perspective, it appears that hypnotic suggestions do not act directly on our executive functions, but rather on our self-monitoring functions. That is, hypnosis does not directly decide our behaviors for us. Rather, it modifies how the brain monitors what it’s doing. So when the hypnotist suggests that you raise your arm, you’re still the one making that decision – although your experience may seem like the arm is moving by itself.

Exposure Therapy & Self-Hypnosis

The aim of hypnotherapy is to induce changes in negative emotions, perceptions and actions. Suppose you are afraid of public speaking. Through suggestions, the therapist may make you go through the experience of talking in front of an audience. Again, it feels real – your stress level will rise, but ultimately you’ll habituate yourself and learn to cope with the stress, even as the therapist suggests increasingly challenging scenarios.

Hypnosis can also be used as a preparation or replacement for exposure therapy, which is a method to treat phobias or anxiety related to specific situations by progressively exposing the patient to increasingly challenging situations. If you’re afraid of birds, the therapist may suggest you imagine holding a feather; then imagine getting near a bird in a cage; then imagine going to the park and feeding pigeons. This is more effective, and feels more real, than mere visualization.

The hypnotherapist can also teach self-hypnosis techniques. Subjects can learn to induce a state of relaxation that’s associated with a gesture, such as closing the left hand.

Hypnotic suggestions like this decrease anxiety by promoting activation of the parasympathetic nervous system, which stimulates bodily functions during times of rest, such as digestion and sexual arousal, and deactivates the sympathetic nervous system, which stimulates the fight-or-flight response.

Progress can occur after less than 10 sessions with some disorders, such as insomnia in children. But it may take longer for others, such as depression. And just as hypnosis is not suitable for everyone, it’s also not suitable for everything.

What’s more, not all hypnotherapy products on the market are backed by scientific evidence. It is safer to go to a hypnotherapist who’s licensed in your state. You should ask whether they are affiliated with or certified by a professional association of hypnotherapists. You can then confirm their affiliation on the association’s website. For instance, the American Society of Clinical Hypnosis allows you to search members by name.

Although Medicare does not cover hypnotherapy, some private insurance partially covers the costs for some conditions, provided the treatment is performed by a licensed clinical mental health professional. One session will typically cost between US$100 and $250.

David J. Acunzo, PhD, is Assistant Professor in the Division of Perceptual Studies at the University of Virginia School of Medicine. His current research interests include abnormal perceptions, response to hypnotic suggestion, and extraordinary experiences including mystical and psi experiences.

This article originally appeared in The Conversation and is republished with permission.

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?

VA Tweet Recommends Spinal Cord Stimulators While Spreading Opioid Phobia

By Crystal Lindell

A recent post on X (formerly Twitter) from the U.S. Department of Veterans Affairs inadvertently highlights one of the ways that opioid phobia is actively causing a lot of harm. 

On Dec. 31, 2024 the VA made this post on X: 

“Spinal cord stimulation implantation helps Veterans suffering from chronic pain improve their quality of life without narcotics.”

The post links to a VA News article headlined: "Columbia VA performs first spinal cord stimulation implantation."

About 50,000 stimulators are implanted every year in the U.S., but this was the first time the VA hospital in Columbia, South Carolina had done one. There are two major problems with the VA’s post and the related article: 

1. Spinal cord stimulators are often ineffective and sometimes so dangerous they have to be removed. 

2. Recommending them as a method of treatment that can be done “without narcotics” serves to demonize prescription opioids, which are both relatively safe and effective. The use of the word “narcotics” rather than “opioids” also feels intentional, as narcotics is commonly used by law enforcement. 

Overall, the VA’s post and the related linked article are emblematic of a now pervasive attitude among medical professionals: Any treatment that reduces opioids must be good. And if that treatment is bad, well, it’s still good.  

Before we go further into the research about why spinal cord stimulators (SCSs) are so problematic, it's important to explain what they actually are. 

Stimulators are surgically placed near the spine, with a small battery also placed under the skin, usually near the buttocks or abdomen. Patients with back, hip or leg pain then use a remote control to send mild electric signals into their spinal nerves to block pain signals to the brain. 

A quick tip as someone who has a lot of experience with medical interventions: Anytime a doctor says they want to start messing with your spine, you should be wary. 

‘Potential for Serious Harm’

Don’t take my word for it though. There’s tons of research highlighting the negative effects of SCSs. 

As an Associated Press investigation in 2018 found, spinal cord stimulators account for the third-highest number of medical device injury reports to the FDA, with over 80,000 incidents flagged over the previous decade. The AP also found that the FDA had more than 500 reports of people with stimulators who died.

In 2022, a study published in the Journal of Patient Safety analyzed adverse effects involving SCSs reported to the Australian Therapeutic Goods Administration. That research found 520 adverse events, with most rated as severe (79%) or life-threatening (13%).

“Spinal cords stimulators have the potential for serious harm, and each year in Australia, many are removed. In view of the low certainty evidence of their long-term safety and effectiveness, our results raise questions about their role in providing long-term management of intractable pain,” researchers concluded.

Additionally, a January 2024 article from the American Academy of Family Physicians headlined: "Despite Weak Evidence, Spinal Cord Stimulators Are Big Business” also highlights their shortcomings. 

In it, author Kenny Lin, MD, writes: "These devices come with a high price tag ($30,000) and potential complications that include electrode migration, hematoma formation, infection, spinal cord injury, and cerebrospinal fluid leak."

Lin also notes that in a 2020 letter to health care providers, the FDA reported that over a four year period, it received nearly 108,000 reports involving SCSs, including 428 deaths, nearly 78,000 injuries, and over 29,000 instances of a device malfunction. 

That seems like an unacceptably high rate of unintended effects for a device with modest benefits.

It’s disappointing, but not surprising, to see the VA perpetuate dangerous medical information promoting spinal cord stimulators, especially as some sort of magical alternative to “narcotics.” 

Messaging from government agencies holds power and needs to be used responsibly. I would hate for a veteran to see that post on X, decide to get a spinal cord stimulator, and then end up with adverse effects. I’d also hate for any VA doctors to see that post and conclude that they should be pushing the stimulators over something like hydrocodone. 

The whole situation reinforces how far we have strayed from rational opioid policy, and how far we have to go if we ever want to have one. At this point, I’m not sure I’ll live long enough to see that happen. 

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?

A Pained Life: How Are You Feeling?

By Carol Levy

When I meet someone on the street, we do the perfunctory, “Hi, how are you?” and the expected reply, “Fine thanks. And you?”

If it's a really good friend, we may start to have a true conversation about how we really feel: “Well, you know I've been going through a tough time lately.”

The friend may nod her head in understanding and say, “Oh I'm so sorry. Let's talk about it.” And then we do.

It’s different when I'm at my neurosurgeon or neurologist's office. When the doctor enters the exam room, he’ll usually say, “Hi Carol, how are you?” I reply, “Fine thanks. And you?”

My question to him is ignored. Unlike my friend, his response is not to ask, "No, Carol. How are you feeling? How is your pain affecting you?”

Instead, we go directly to clinical questions like, “Has your pain changed in any way?” or "Are the medications helping you any?”

In my last column, I wrote about wanting doctors to be able to feel what we feel, and to understand what it’s like to have the levels of pain that we endure. Too often, their words and actions indicate they truly don't understand or care.

A few days after I wrote that column, I was in my family doctor's office. We did the “How are you?" thing. He then asked me why I was there.

"I saw some bad blood work results on another doctor's patient portal,” I said. “It's been 2 months. I assumed she didn't call me because the results were good. But now that I saw them, I want to know what they mean." 

“Well,” he started off, “We see thousands of patients and we can't remember to follow through on all of them. You should have called her." 

If that was intended to make me feel small, he succeeded.

“Yes, your cholesterol is terrible You have to take statins,” he said. I told him I didn’t like statins. He didn't ask me why, but warned, “If you don't, you'll have a heart attack.”

My life has been hard, the chronic pain making it a gazillion times harder. I am virtually alone, which makes my life worse. “I don't have an interest in extending my life,” I said. 

I didn't say that to get sympathy. It's my reality. I did, however, expect a response --- a grimace, a nod of the head, or some words of concern or care. None were forthcoming. Instead, he ignored my comment.

When I asked about the risks of statins, he ignored that too, repeating what seemed like a scare tactic: “You'll have a heart attack.”

Had he heard and listened to my words, he would have realized that was not going to have an effect on me.

I had a few other issues. Each one was met with a quick one or two-word answer. I asked him for prednisone, a steroid, as it had previously helped my sciatica. “No,” was his response.

I explained how prednisone helped me before, and that I wanted some in the house for the times when the sciatica gets bad. “I don't want you taking a steroid every day,” he replied.

I hadn't asked or indicated that I wanted to take it daily. He just came to his own conclusion. I explained again that I only wanted it for the “just in case” days. Unhappily, based on his expression, he agreed.

Then the appointment ended. I turned away for a second to get my purse.  When I turned back, he was out the door. Without even a goodbye.

Not once did he ask, “How are you? How are you emotionally? How are these issues affecting you? How are you doing with your pain?”

As I thought about his indifference to me, a person with emotions and feelings, I thought about all of the doctors I’ve seen since my trigeminal neuralgia and chronic pain started. Sadly, I could only think of two out of 20 or more who actually cared about how I was, the emotional, psychological me.

I know every doctor, like every person, has felt what I felt. Not necessarily the depths of despair some of us feel about having pain, or the fear that we have on a good day that the pain is just lurking around the corner. No one is immune from those thoughts.

So many articles have posited that those of us with chronic pain have psychological issues stemming from prior events, such as childhood trauma, that caused our pain and disabilities. 

How am I feeling, doctor? Ask me. It may help you to understand me, my pain, and my other medical issues. And, just by asking, you may be able to help yourself be a better doctor.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

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.”   

Trump’s Picks for Top Health Jobs at Odds With Each Other

By Stephanie Armour and Julie Rovner, KFF Health News

Many of President-elect Donald Trump’s candidates for federal health agencies have promoted policies and goals that put them at odds with one another or with Trump’s choice to run the Department of Health and Human Services, Robert F. Kennedy Jr., setting the stage for internal friction over public health initiatives.

The picks hold different views on matters such as limits on abortion, the safety of childhood vaccines, the covid-19 response, and the use of weight-loss medications.

The divide pits Trump picks who adhere to more traditional and orthodox science, such as the long-held, scientifically supported findings that vaccines are safe, against often unsubstantiated views advanced by Kennedy and other selections who have claimed vaccines are linked with autism.

The Trump transition team and the designated nominees mentioned in this article did not respond to requests for comment.

It’s a potential “team of opponents” at the government’s health agencies, said Michael Cannon, director of health policy studies at the Cato Institute, a libertarian policy organization. Kennedy, he said, is known for rejecting opposing views when confronted with science.

“The heads of the FDA and NIH will be spending all their time explaining to their boss what a confidence interval is,” Cannon said, referring to a statistical term used in medical studies.

Those whose views prevail will have significant power in shaping policy, from who is appointed to sit on federal vaccine advisory committees to federal authorization for covid vaccines to restrictions on abortion medications. If confirmed as HHS secretary, Kennedy is expected to set much of the agenda.

“If President Trump’s nomination of RFK Jr. to be secretary is confirmed, if you don’t subscribe to his views, it will be very hard to rise in that department,” said Amesh Adalja, an infectious disease specialist and senior scholar at the Johns Hopkins Center for Health Security.

“They will need to suppress their views to fit with RFK Jr’s. In this administration, and any administration, independent public disagreement isn’t welcome.”

Kennedy is chair of Children’s Health Defense, an anti-vaccine nonprofit. He has vowed to curb the country’s appetite for ultra-processed food and its incidence of chronic disease. He helped select Trump’s choices to lead the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health. If confirmed, he would lead them from the helm of HHS, with its more than $1.7 trillion budget.

Clashes are likely. Kennedy has supported access to abortion until a fetus is viable. That puts him at odds with Dave Weldon, the former Florida congressman whom Trump has chosen to run the CDC. Weldon, a physician, is an abortion opponent who wrote one of the major laws allowing health professionals to opt out of participating in the procedure.

Weldon would head an agency that’s been in the crosshairs of conservatives since the covid pandemic began. He has touted his “100% pro-life voting record” on his campaign website. (He unsuccessfully ran earlier this year for a seat in Florida’s House of Representatives.)

Trump has said he would leave decisions about abortion to the states, but the CDC under Weldon could, for example, fund studies on abortion risks. The agency could require states to provide information about abortions performed within their borders to the federal government or risk the loss of federal funds.

Vaccine Safety

Weldon, like Kennedy, has questioned the safety of vaccines and has said he believes they can cause autism. That’s at odds with the views of Marty Makary, a Johns Hopkins surgeon whom Trump plans to nominate for FDA commissioner. The British American said on the “Brian Kilmeade Show” on Fox News Radio that vaccines “save lives,” although he added that it’s good to question the U.S. vaccine schedule for children.

The American Academy of Pediatricians encourages parents and their children’s doctors to stick to the recommended schedule of childhood vaccines. “Nonstandard schedules that spread out vaccines or start when a child is older put entire communities at risk of serious illnesses, including infants and young children,” the group says in guidance for its members.

Jay Bhattacharya, a doctor and economist who is Trump’s selection to lead NIH, has also supported vaccines.

Kennedy has said on NPR that federal authorities under his leadership wouldn’t “take vaccines away from anybody.” But the FDA oversees approval of vaccines, and, under his leadership, the agency could put vaccine skeptics on advisory panels or could make changes to a program that largely protects vaccine makers from consumer injury lawsuits.

“I do believe that autism does come from vaccines,” Kennedy said in 2023 on Fox News. Many scientific studies have discredited the claim that vaccines cause autism.

Ashish Jha, a doctor who served as the White House covid response coordinator from 2022 to 2023, noted that Bhattacharya and Makary have had long and distinguished careers in medicine and research and would bring decades of experience to these top jobs.

But, he said, it “is going to be a lot more difficult than they think” to stand up for their views in the new administration. It’s hard “to do things that displease your boss, and if [Kennedy] gets confirmed, he will be their boss,” Jha said.

“They have their work cut out for them if they’re going to stand up for their opinions on science. If they don’t, it will just demoralize the staff.”

Most of Trump’s picks share the view that federal health agencies bungled the pandemic response, a stance that resonated with many of the president-elect’s voters and supporters — even though Trump led that response until Joe Biden took office in 2021.

Kennedy said in a 2021 Louisiana House oversight meeting that the covid vaccine was the “deadliest” ever made. He has cited no evidence to back the claim.

Federal health officials say the vaccines have saved millions of lives around the globe and offer important protection against covid. Protection lasts even though their effectiveness wanes over time.

The vaccines’ effectiveness against infection stood at 52% after four weeks, according to a May study in The New England Journal of Medicine, and their effectiveness against hospitalization was about 67% after four weeks.

The vaccines were produced through Operation Warp Speed, a public-private partnership Trump launched in his first term to fast-track the shots as well as other treatments.

Makary criticized covid vaccine guidance that called for giving young children the shots. He argued that, for many people, natural immunity from infections could substitute for the vaccine. Bhattacharya opposed measures used to curb the spread of covid in 2020 and advised that everyone except the most vulnerable go about their lives as usual. The World Health Organization warned that such an approach would overwhelm hospitals.

Mehmet Oz, Trump’s choice to head the Centers for Medicare & Medicaid Services, an agency within HHS, has said the vaccines were oversold. He promoted the use of the anti-malaria drug hydroxychloroquine as a treatment. The FDA in 2020 revoked emergency authorization of hydroxychloroquine for covid, saying that it was unlikely to be effective against the virus and that the risk of dangerous side effects was too high.

Janette Nesheiwat, meanwhile, a former Fox News contributor and Trump’s pick for surgeon general, has taken a different stance. The doctor described covid vaccines as a gift from God in a Fox News opinion piece.

Kennedy’s qualms about vaccines are likely to be a central issue early in the administration. He has said he wants federal health agencies to shift their focus from preparing for and combating infectious disease to addressing chronic disease.

The shifting focus and questioning of vaccines concern some public health leaders amid the spread of the H5N1 bird flu virus among dairy cattle. There have been 60 human infections reported in the U.S. this year, all but two of them linked to exposure to cattle or poultry.

“Early on, they’re going to have to have a discussion about vaccinating people and animals” against bird flu, said Georges C. Benjamin, executive director of the American Public Health Association. “We all bring opinions to the table. A department’s cohesive policy is driven by the secretary.”

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

Brain Stimulation May Prevent Chronic Pain Before It Starts

By Pat Anson

Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic pulses to stimulate nerve cells in the brain. TMS is typically used to treat depression, but is increasingly used off-label to relieve chronic pain conditions such as migraine, fibromyalgia and peripheral neuropathy.

Research recently published in the journal PAIN suggests that TMS may also be useful in preventing pain before it even starts.

A team of international researchers gave 41 healthy volunteers a 5-day course of either repetitive transcranial magnetic stimulation (rTMS) or sham treatment. Both targeted the left primary motor cortex, a part of the brain that controls movement.

After the fifth and final session, all of the volunteers had an injection of nerve growth factor into their cheeks to induce prolonged pain. For the next two weeks, participants kept diaries of their jaw pain, jaw function and muscle soreness.

“We found that a five-day course of rTMS before pain onset has the potential to interrupt the transition to chronic pain,” said lead author Nahian Chowdhury, PhD, Head of Neurostimulation at the NeuroRecovery Research Hub at the University of New South Wales in Australia.

“We were looking to see what the experience was for participants who had received the rTMS, versus what happened for those who had received the sham. Those people who had received active rTMS experienced lower pain on chewing and yawning than those who received the sham.”

Chowdhury and his colleagues also found that two measurements of brain activity -- Peak Alpha Frequency (PAF) and corticomotor excitability (CME) – seemed to moderate pain whether participants received rTMS or not. This suggests that monitoring PAF and CME may be useful in predicting each individual’s pain resilience.

“Regardless of whether people received the active treatment or sham, our analysis showed that those with faster PAF and higher CME on Day 4 had lower intensity future pain,” Chowdhury said in a news release from NeuRA, an Australian medical institute where he is a research fellow.

This is the first study to show that rTMS can have a protective effect against chronic pain. More research is needed, but the findings open the door for preventative treatments for those at high risk of developing chronic pain.

​“Whilst chronic pain is a significant problem, the current interventions are usually only applied once the pain is chronic,” Chowdhury said. “This research shows in some situations – such as for people undergoing a surgery known to be painful or often leading to chronic pain – there is promise from preventative treatments that may be able to stop chronic pain before it begins.”

PNN Columnist Madora Pennington, who has Ehler-Danlos syndrome, tried TMS therapy and found it eased her pain, depression and anxiety.

“Since having TMS, I notice that my body is less sensitive to touch,” she wrote. “It does not hurt as much to be poked at or pressed on. The extra comfort TMS has given me, both mentally and physically, is a lot for someone with medical problems like mine that are so difficult to treat.”

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.