Shots Fired!! Two of the most prestigious medical journals just came out fiercely against epidural injections

Posted on March 2, 2025 by Pharmaciststeve

Shots Fired!! Two of the most prestigious medical journals just came out fiercely against epidural injections / RFA.

The British Medical Journal just published a “Practice Guideline” paper with these damning statements:

“For people living with chronic radicular spine pain, the guideline panel issued strong recommendations against: epidural injection of local anaesthetic, steroids, or their combination.”

“For people living with chronic axial spine pain, the guideline panel issued strong recommendations against: joint radiofrequency ablation.”

The New England Journal of Medicine’s “Journal Watch” then doubled down on this stance (links in comments):

“The unfortunate reality is that some patients with chronic cervical or lumbosacral pain don’t respond to standard first-line noninvasive measures. They are understandably desperate for relief, and clinicians understandably feel obligated to “do something”.

However, none of the procedures covered in this guideline afforded clinically important pain relief with moderate certainty, according to the panel. In their concluding remarks, the authors also address the high cost of these procedures in the U.S., noting that “the substantial reimbursement… may act as a perverse incentive for their delivery.”

I’m a little bit stunned.

What do policy-makers want? For every spine patient to live eternally in a purgatory of PT and acupuncture and cognitive-behavioral therapy… even if they aren’t getting relief?

What is the impact of this philosophy on workforce productivity, long-term disability, and human misery?

Don’t get me wrong… I love the “less is more” mentality.

But do these journals/authors know the power of these words… especially when exploited by denial-addicted insurance companies?

It’s funny… a lot of conversations tend to pit spine surgeons like myself AGAINST our interventional pain colleagues.

On this day… maybe we need to band together.

Who else will act as custodians and stewards of spine care in this country?

Taif J. Mukhdomi Dr. Soubrata V. Raikar Raul Monzon MD Chris Centeno, M.D.

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Your Body, Your Health Care

Posted on March 1, 2025 by Pharmaciststeve

Your Body, Your Health Care

https://www.cato.org/events/your-body-your-health-care

AVAILABLE APRIL 8TH. Pre-order at retailers now.

• Published By Cato Institute
By Jeffrey A. Singer

At a time when individuals feel increasingly disenfranchised by their health care choices, Dr. Jeffrey A. Singer’s groundbreaking new book, Your Body, Your Health Care, offers a compelling vision for a future in which patients regain control over their health decisions and care. The book underscores the importance of personal autonomy, highlighting how the patient-practitioner relationship has been overshadowed in recent decades by paternalistic and overbearing government intervention.

As government regulations continue to encroach upon personal health care choices, patients find themselves at the mercy of policymakers dictating their treatment options, from which health professionals they can consult to what substances they can ingest. In this timely work, Dr. Singer, a seasoned surgeon and policy expert, delves into the philosophical underpinnings of a health care system that respects individual sovereignty and moral agency.

“In the following pages, I want to inform you about how lawmakers and policymakers at all levels of government have failed to heed the pronouncement that ‘every human being of adult years and sound mind has a right to determine what shall be done with his own body,’” Dr. Singer emphasizes. “I hope to expose the harmful unintended consequences of this paternalism. Finally, I want to point out roads leading to a future where the government respects the autonomy and rights of all adults.”

Your Body, Your Health Care not only validates the grievances of patients but also presents a philosophical framework for the relationship between individuals, the health care system, and the state. Through thoughtful analysis of issues such as prescription requirements, the right to self-medicate, access to harm-reduction techniques, and licensing laws, Dr. Singer proposes a road map for reforming health care policy that prioritizes individual rights and provides essential reading for anyone concerned about the future of health care in America. It serves as a clarion call for change, urging readers to recognize their rights and the preservation of personal sovereignty in America.

Praise for the book

“Dr. Singer’s writing is engaging and always informed by his clinical experience, sharp insight into the unintended consequences of policy, and ethical commitments. Your Body, Your Health Care is a book worth reading, arguing over, and thinking about. Ultimately, Dr. Singer’s book provides a stark reminder that patient autonomy is still a vital ethical principle worth keeping.”
—Jay Bhattacharya, MD, PhD, professor of health policy, Stanford University

“Dr. Singer’s book is well written, well researched, and very provocative. Whether or not the reader agrees with everything that Dr. Singer writes about the regulatory state, they will be challenged to think differently and/​or to defend to themselves why they disagree. If the reader is a policymaker, they may be taking notes as to legislation to propose.”
—Sen. Bill Cassidy, MD (R‑LA)

“In an era when government officials and health experts are way too quick not only to tell you what’s best for you but also to mandate it with the force of law, Dr. Jeffrey A. Singer’s Your Body, Your Health Care is a righteous vaccine for the body politic.… His maximalist case for patient autonomy, informed consent, and the right to self-medication is exactly what we need in a world that is busting open with nearly infinite new treatments and cures for everything that ails us.”
—Nick Gillespie, editor at large, Reason

“Singer delves into some of the most pressing and contentious health care issues in the United States today. His criticism of the FDA is both thought-provoking and disturbing, as are many other sections in the book. Everyone concerned about government intrusion on patient autonomy should read this.”
—Josh Bloom, PhD, director of chemical and pharmaceutical research, American Council on Science and Health

About the author

Jeffrey A. Singer is a senior fellow at the Cato Institute and works in the Department of Health Policy Studies. He is president emeritus and founder of Valley Surgical Clinics Ltd., the largest and oldest group private surgical practice in Arizona, and has been in private practice as a general surgeon for more than 35 years.

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Opioids – how forced tapers do more patient harm than just increased pain

Posted on February 28, 2025 by Pharmaciststeve

Opioids – how forced tapers do more patient harm than just increased pain

https://www.linkedin.com/pulse/opioids-how-forced-tapers-do-more-patient-harm-than-just-neen-monty-ugrwc

Taking away my opioid pain relief is not only medically endorsed torture, it is taking away my ability to access treatment for my severe, late-diagnosed, long-standing disease, CIDP.

I have been very sick lately.  Why?  Because I missed my fortnightly IVIG infusion.  This infusion is very important, it treats my severe, long standing, late-diagnosed chronic inflammatory demyelinating polyneuropathy (CIDP).

This is the worst pain that I experience.  It is constant and severe, neuropathic and nociceptive pain.  It is caused by the demyelination of my nerves, and the consequent spasming of my muscles.  Again, it is constant, severe, chronic pain.

It is secondary pain.  Secondary to another disease, in this case CIDP.  Having been in pain for almost 20 years, I have addressed all the psychosocial aspects of pain. I have modified all the modifiable features of my pain.

The only thing that reduces my pain, enough so that I can function for an average for four hours a day, is opioids. Oxycodone, to be precise.

My pain management doctor is force tapering me.

She has no medical reason to do this.  NONE. She is misinformed and following outdated guidelines.

But last time I checked guideless were….guidelines.

NOT hard and fast rules!

As a doctor, she is supposed to provide individualised care. She is supposed to use her clinical judgement, not just follow a checklist.  She is to improve my life, not destroy it.

But she has all the power and I have none.

I tried a day without pain medication a few weeks ago and it was unbearable. I lasted 26 hours before I caved and took the pain medication.

Two weeks ago, I saw my GP. And she berated me for abandoning the taper.  She insisted I try again.

So, I did.

I saw her Friday.  I forgot on Saturday and took my normal dose.  Sunday, I took the reduced, taper dose.

Sunday was unbearable.

Monday was unbearable.

I woke up Tuesday, unable to walk, let alone drive. I go every second Tuesday.  I called the infusion centre to let them know that I could not drive, and I could not sit in the infusion chair for four hours, even if I had transport.

They were very kind, empathetic and compassionate. At least two nurses there are openly outraged that this is happening to me. The doctor there is wonderful, but he can’t say much about the taper, but he is…perplexed, shall we say. At the treatment plan that is clearly making my life harder and ruining my functional life.   He is watching me deteriorate and he askes me why my pain doctor is doing this.  I told him ‘Guidelines’.  He shook his head but said nothing.

That Tuesday, after being unable to attend my infusion, I was so angry and fed up and unable to cope with the pain anymore that I took my normal dose. Tuesday was still agonising.

Wednesday, I took my normal dose, but it was not enough to cut it.  I was in terrible pain all day.

Thursday, I stated to feel a reduction in pain. Once pain gets out of control like that, its impossible to get it back under control with your ‘usual’ dose. So, the great irony here is that I wound up using MORE pain medications because of this asinine forced taper. To get my pain back under control.

But the other thing I realised is how much the IVIG infusion does for my other symptoms. The fatigue.  The dizziness on standing. The muscles weakness.  The general feeling of being sick…malaise? I don’t know if that’s the right medical word.

Feeling like you have the flu, all the time.  Aches and pains, sure. Severe neuropathic pain, sure. But the fatigue was unreal. The heaviness in my legs…I could barely lift them.  I needed a wheelchair, even in the house.   And my house is not set up for the wheelchair, because mostly I can get by with a walker in the house.

I spent most of the week in bed anyway, not just because of pain but because I was too weak and too sick to do anything.

My life is slipping away from me. Because this doctor is not only condemning me to constant, severe pain.  Pain that NO ONE can live a functional life with.  But also, she is preventing me from accessing treatment for my DISEASE.  She is preventing me from having any chance of remission or even slowing progression.

She is killing me. Plain and simple.

I’m sure most people will not be happy with that characterisation, but what would YOU call it?

She is killing me slowly and painfully. She is torturing me to death.

Again, my pain is not functional. It is not psychosomatic. It is not psychosocial. It is not primary. It is NOT non-specific.

It is pathological pain.

There is known disease process going on. Biopsy proven nerve damage, demyelination and remyelination, naked axons and axonal degeneration.  This is permanent, because four neurologists couldn’t read an MRI and ignored a lumbar puncture.  I have no ankle reflexes, which is impossible to fake, in case you think my biopsy was faked somehow.  And I have lost a lot of muscle mass.

I have severe disease. It is VERY painful.

The four neurologists who dismissed me as a neurotic or hysterical woman, and called it ‘functional’ ruined my life when they failed to diagnose my disease. Because of THEM, I live with constant, severe, pain and I live with severe disabling weakness.  IF they’d diagnosed me early, I would have had a chance at treatment, at remission. But no.  They were lazy and decided it was ‘functional’.  Thereby condemning me to a lifetime of pain and disability.

You could say my disease and disability are iatrogenic, because of doctor failure.   Four of them.

Now, insult to injury, pain management doctors refuse to treat the pain that severe, late-diagnose disease causes.

Just take a moment to consider just how FAR doctors have let me down. How badly they have failed me.

Ten years ago, presenting with severe disease, I would have been given empathy support and PAIN RELIEF.

Now? I am given pain science education which obviously does nothing for pathological disease.

I am given psychological treatments for pathological disease.

I am given the eye rolls, because ‘it can’t be that bad’.

I am given nothing.  No empathy, no compassion, no pain relief.

I am given nothing.

No one can argue that this taper is for my benefit.

This is happening to people all around Australia, every day.

Help us STOP THE FORCED TAPERS!

Pain Patient Advocacy Australia.

The FPM and the RACGP are using FLAWED AND OUTDATED opioid prescribing guidelines. HELP US UPDATE THE GUIDELINES AND STOP THE MEDICALLY SANCTIONED TORTURE OF PEOPLE LIVING WITH PAINFUL, PROGRESSIVE, INCURABLE DISEASE!

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There’s Big Money in Withholding Pain Relief

Posted on February 27, 2025 by Pharmaciststeve

There’s Big Money in Withholding Pain Relief

https://www.americanthinker.com/articles/2025/02/there_s_big_money_in_withholding_pain_relief.html

Pain is the most common reason for seeking medical care.  Although pain is experienced only by individuals, under federal policy, pain is a public health challenge, even a global health priority.  In a way, this isn’t surprising, as modern definitions of health and public health are expansive, even including transitory mental and emotional states.

Public health as a concept arose along with eugenics during the Progressive Era.  Although the two concepts weren’t completely congruent, both were compatible with government assuming authority to act on behalf of the health of the population.

Logically, a healthy community isn’t a thing.  All populations include some individuals with disease or infirmity.  But the concept of public health offers an opportunity for authoritarian control.  Health-linked government actions extend beyond reasonable efforts like  sanitation, clean water, and emergency stockpiles for disasters or epidemics.

Since 2010, the National Pain Strategy, created by the NIH and Institute of Medicine (IOM) has been our government’s “comprehensive population health-level strategy for pain.”  The Federal Pain Research Strategy (FPRS) was added later.  Congress has a Best Practices Inter-Agency Task Force to align with the NPS.  The NIH has an Office of Pain Policy.  The National Institute of Neurological Disorders and Stroke has an Office of Pain Policy and Planning.

The Executive Summary of the FPRS lists these priorities: “dissemination and implementation of research to support the translation of scientific discoveries into clinical practice and improve the lives of people in pain.”  The IOM anticipates “cultural transformation in pain prevention, care, education and research” via population-level strategy.

The fact that millions of law-abiding Americans suffer chronic and severe pain is clearly not news to our government.  Massive federal funds are earmarked for research seeking alternative pain treatments and shoring up unfounded links between prescribed opioids and opioid use disorder, overdoses, and deaths.

Since 2005, the Blueprint for Neuroscience Research has funded research initiatives, training opportunities, tools, and neuroscience resources focused on pain.  Participating federal agencies include the National Center for Complementary and Integrative Health, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, and Office of Behavioral and Social Sciences Research.  The Blueprint’s 2025 budget is $2.8 billion.

Helping End Addiction Longterm (HEAL) dominates internet searches related to pain care.  Another collaboration of multiple federal agencies, HEAL funds 1,800 projects in 50 states and spent over $3 billion between 2019 and 2023.  Research funded by HEAL includes opioid use disorder and addiction, managing pain while reducing opioid use disorder, preventing opioid use disorder and addiction, new and non-addictive analgesics, new pain targets and mechanisms, and finding links between pain and substance abuse.

“Opioid use disorder” — distinct from substance abuse disorder — was first incorporated in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) in 2013.  NIMH refused to support DSM-5 because of inclusion of diagnoses not supported by laboratory measurements.  NIMH shifted funding away from research based on DSM-5.  Clearly, things have changed since then.

Drill into every federal funding opportunity involving pain, and the priorities are clear.  Connect prescribed opioids with opioid use disorder, substance abuse, or addiction.  Develop and promote non-opioid treatments.  Promote non-opioid treatments whether they work or not (they don’t).  Minimize prescribing and maximize demonization, as if prescribed opioids were a global threat to carbon-based life forms.

Problematic opioid use following a prescription is extremely rare.  JAMA data published in 2016 on over half a million surgery patients not prescribed opioids for at least a year.  A reference sample of 18 million subjects received no surgery or prescriptions.  Subsequent opioid misuse ranged from 0.119–1.14% for the surgery patients and 0.136% for reference subjects.  In 2018, the BMJ published data following over 2 million patients prescribed opioids for the first time after surgery.  The post-surgery misuse rate was 0.6%.  But federal budgets continue to support research seeking a link that years of data already disproved.

The Federal Pain Research Strategy Summary includes one key admission: “Novel pharmacologic treatments for pain have not emerged for some time.”  Not for lack of spending.

Often treatments prescribed for pain are not opioids, despite lack of evidence that alternative treatments have any significant benefit.  Psychiatric medications such as gabapentin, amitriptyline, and duloxetine have been prescribed off-label for decades, with scant evidence of efficacy.  Gabapentin withdrawal symptoms are remarkably similar to opioid withdrawal.  Spinal stimulation implants aren’t guaranteed to relieve pain, while patients have reported negative side-effects for years.  No alternative has yet shown effectiveness for pain that comes close to opioids.  All that can be inferred from existing evidence is that some physical treatments, like chiropractic, may help reduce pain in conjunction with an analgesic.

It’s almost refreshing to see an NIH publication admit that research focuses on “opioid use, misuse and addiction” with a “dearth of federal funding for studying interventional pain management.”  Interventional pain management means invasive procedures, including spinal stimulation, nerve blocks, and surgery.  Our modern medical establishment calls this a holistic approach.  Existing opioids have no place in this vision of pain care.

In 2017, half of Americans had tried alternative treatments, but only 20% used them instead of conventional care.  As of 2021, only 2% of Americans had tried acupuncture.

Among pain patients surveyed in 2024, 77% were willing to consider alternative treatments, and 65% were willing to try acupuncture.  Pain makes people desperate.  Desperation makes people vulnerable to unfounded ideas.

Untreated pain affects endocrine, cardiovascular, immune, neurological, muscle, and skeletal function.  Pain patients suffer exhaustion, memory deficit, attention deficit, and cognitive decline.  Decreasing activity, declining fitness, and increasing obesity are followed by joint weakness, neuropathies, muscle contractions, hypertension, and tachycardia.  “Cardiovascular death is a common occurrence among persistent pain patients, likely due to a multitude of factors.”

Government funding for anything-but-opioids continues.  Taxes pay for researching and promoting mindfulness (teaching pain patients what to think), swearing (when patients tire of being told what to think), placebos (faking re-classified as legitimate treatment), yoga (a religious practice), and deep brain stimulation.  So much more than merely wires inside your skull, deep brain stimulation is wires inside your skull plus bilateral upper chest implants.  When there’s effective oral medication (opioids), who would choose enough implants to qualify as a Borg?

The only transformation of pain care that should occur in the U.S. is to return prescribing decisions to doctors and stop government bureaucrats practicing medicine without a license.

 

 

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United we stand, divided we fall

Posted on February 26, 2025 by Pharmaciststeve

A video diatribe attacking yours truly over something that I SHARED ?

Bob Sheerin Favorites 

Admin
Top contributor

 onesdpSotrg853lgh9iucf7m17futih52i6t0c7m2h250a9h4h0ff877f0f3 

@everyone LOOK AT THIS IDIOT WHILE WERE GOING AFTER ALL THE LEGISLATION BILLS? WTF

This is so sad! I fought and won 50 million dollars + plus for pain pump patients all over the USA over all this! I found the attorneys and took thousands of messages and complaints! Not to mention it put my whole family in financial ruin but thanks for posting! Then turned around and exposed 83k complains from assorted implant groups mostly my groups …to expose the FDA! Not to mention Illinois patients who now have a bill wrote by Kat Hatz and John Flannery we offer every state to get your foot in their legislative door ..or.. Washington State patients and helping others get to their legislative meetings from other orgs? Did you ever do that? Then she gets 3 women whom I never met personally send me restraining orders that cost children to suffer for 6 months while I had to fight to get the TRO crapped on…. Get this selling illict fentyal and calling names Matter of fact I should post the restraining order now seeing they were gone when the lawyer squished them and of course gave the felon back his hunting rifles 🤣 Do they let felons have riffles now? I forget! For the love of god Stop! So maybe I should charge from now on! All of sudden I want to open a patreon page and talk about suboxone teeth and made up stories from the comfort of my home… Instead of being in Wahington DC 25+ times! My god APDF has appointments in Wahington DC for 16 of YOUR STATES! What is this women thinking? I will be suing her immediately for slander and accusing me of being a felon! I have Congressmen and Senators calling me weekly and she post this garbage? Y’all this women is a DEA worker… Its almost like she sabotages great projects if their not hers but then again I havent seen any projects besides Patreon (making money projects in a long ass time) if at all. I followed her for years and made donations to find out later they lost 20k in gofundmes to sue Kolodny! Then she said that wasn’t mine..🤣 What Dave Weland posted the videos of you asking for money? Or was that another 70 year old beauty queen. Let the poor lady take the fall.shame on You. While she’s promoting it? Then she blames it on my good friend Dr Feldman Maybe he needs to do a live and explain what really happened? So she waits til I have heart surgery to attack for the 9th time since our last blow out when I have kept absolutely quiet even know I know shes full of shit on atleast 4 projects 🤣! Nothing makes me madder than coming after me and torturing my kids with bullshit restraining orders and yeah that was so fun watching them suffer because of you and the people decided their fates! I’ve kept my comments to myself but I’m fucking tired of this idiot. Shirl and I had 5 or 6 Congressman who made sure we weren’t with DPF or DPPR or whatever you are now …before they even seen us! Point is they seen us and where were you again! Running your mouth on the internet is absolutely necessary but wrong dude Claudia… aim that nasty mouth at the real enemy you know your boss (Dea!) Not the broke guy who’s spend 300× times more than you with 200× times less money! Maybe she will figure out someday why 95% of APDF senior staff wised up and came from DPF or DPF who got attacked and now are at APDF. You would think she’d atleast shut her nasty face for the kids sake! Shows how much you mean to her! She will trade kids for vengeance 🤣 I’d really think about what she will do to you…. my god! Shit I still want my GFM back for suing Kolodny or maybe it went on that new Porsche everyone bought her 🤣 Hell I’ve gotten 50 times more done in this community and I’d be happy with a frigggen used Kia 🤣 So DC at the beginning of April and attack us in February hmmm…? Almost sounds like an agent of the goverment to me! Especially the timing! Last time was the Washington DC protest when we produced more folks than 15 of her Rally’s but she’s supposedly has 500 times the people we do? How does that add up? I’ll tell you bots lots of them! Oh I forgot APDF helped folks get there who couldn’t afford it? Gaurntee she won’t do that 🤣 so no more 6 people rallys for any of you! What an embarrassment!
And is just me or do we make fun of people who tried to take their own lives? How absolutely sick is this lady? How horrible! Again I say all our funds are public… Ask Claudia to show hers… but she won’t because she is now paying employees so she’s FOR PROFIT. LISTEN AGAIN SHES FOR PROFIT! This ends tomorrow so does her Porsche payment! So why does she want this to end? Yall may want to look at her Board of Directors and then look at the Rhode Island rules on 501c3s… no family members and must be in State! You’re paying her to work crappy bills in RI….Its the worst bill the pain community and its hurt more than helped especially for acute pain patients! When we gave free bills wrote by lawyers for free for all States without pain bills? Maybe I’m doing this wrong? Spend some of that money CM! But please send my 250.00 back for suing Kolodny that never happened? Do you know what I could do with that lost 20k that just up and disappeared? Damn that would help a lot of kids but so would Claudia not attacking every advocate that does anything and it seems like every Tuesday 🤣! Omg who attacks Steve Ariens for god sakes And for the record Ms. Claudia put your record up against any of APDF advocates or any other other boots on the ground orgs advocates that work for free and acually help folks! I’m glad you posted all that because you finally talked a lawyer into helping APDF sue you for free! See you do get stuff done with that nasty mouth of yours! What does the goverment pay you anyways? Attacking me again right before Washington DC for no reason knowing I’m sick says I’m getting closer to ruining your goverment friends and when I’m in DC you know for the 26th time on my own dime.. maybe you should donate some of those new Porsche payments 🤣 that would help more than sabotaging boots on the ground advocates that have scored massive wins over the last 5 years…. Put your record up or go away! You have great advocates spend that money and send them to DC instead of going to Library’s in states that people are dying in! Pay attention now… this is important…. If you don’t want to send them to DC send them to me and APDF will pay to send them like we have done from the beginning! Keep a close eye on a lot of States Claudia because now your gonna have to explain why a broke ass Foundation like APDF can work on all these states with little to no money and you with all the money hasn’t put out shit but love to slander folks acually doing something probably hurt your feelings just a little bit, but the huge things coming out in the next few months will show you….you better get something done quick because the little broke ass APDF foundation has huge things coming! Stuff you already said yall were working on 🤣 I’ll tag you just so you know PEOPLE ARE WATCHING! Oh and thank and your minions for getting my “X” page taken while in DC! Wow that’s not hate that’s sabotaging pain patients 🥲 What a shame! You’re a joke! My gut tells me if you were really a pain patient you wouldn’t be so ready to rip pain patients off. Put the money back in the community and I gaurntee you will actually get something done if you try hard enough! You don’t need to attack.. just do as much as everyone else then you won’t feel so bad! Notice Claudia knows the story and posted this morning anyways after I asked her for help years ago when this was going on and she said talk to my legislation 🤣 love advocates who give out medical information on people who ask for help and then put it out when she’s mad at you 🤣 great advocate 🤣 You ran off too many great advocates Claudia and if I’ve shown you anything in the last 7 years is I don’t back down from you nor will I ever! But I will be opening a patreon and acually offering advocates services.. I hate patreon but I think I hate you more… So I will be competing with you now and maybe I’ll get my used KiA 🤣🤣🤣

Filed under: General Problems | 4 Comments »

As seen on the web

Posted on February 25, 2025 by Pharmaciststeve

Filed under: General Problems | 1 Comment »

Ozempic, Wegovy Shortage Is Officially Over Compounders given 60- to 90-day notice

Posted on February 24, 2025 by Pharmaciststeve

Ozempic, Wegovy Shortage Is Officially Over

Compounders given 60- to 90-day notice

https://www.medpagetoday.com/endocrinology/diabetes/114324

The shortage of semaglutide injections (Ozempic, Wegovy) is over, the FDA announced on Friday.

The agency, along with maker Novo Nordisk, confirmed that supply now meets or exceeds both the current and projected U.S. demand. The injectable formulation of the GLP-1 receptor agonist has been in shortage since August 2022 due to increased demand.

“Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies,” the FDA noted in a statement.

The shortage resolution applies to all strengths of semaglutide for type 2 diabetes, chronic weight management and major adverse cardiovascular event risk reduction.

The FDA said it will give compounders a grace period of 60 to 90 days to finish producing, distributing, and dispensing copies of semaglutide injection products to “avoid unnecessary disruption to patient treatment.”

Compounders are allowed to make copies of a drug only when it’s on the FDA shortage list, meaning the demand or projected demand of that drug exceeds the U.S. supply.

“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand,” said Dave Moore, executive vice president of U.S. operations and global business development and president of Novo Nordisk, in a statement

“No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients,” he added.

Two other GLP-1 receptor agonist products — dulaglutide (Trulicity) and liraglutide (Victoza, Saxenda) — still remain in shortage, the FDA noted.

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Governor of Maine stated she is not going to follow Presidential EO on trans woman playing in female sports

Posted on February 22, 2025 by Pharmaciststeve

On February 5, 2025, President Donald Trump signed an executive order titled “Keeping Men Out of Women’s Sports,” which bans transgender women and girls from competing in women’s sports categories at educational institutions[1][2][4]. This order is based on the Trump administration’s interpretation of Title IX, the federal law prohibiting sex discrimination in educational programs receiving federal funding[2].

Key aspects of the executive order include:

1. Prohibition: The order mandates that transgender girls and women cannot participate in sports designated for females or use women’s locker facilities in educational settings[1].

2. Enforcement: The Department of Justice is directed to enforce this prohibition, and the Department of Education is tasked with scrutinizing schools suspected of non-compliance[1][4].

3. Funding implications: Educational institutions that do not comply risk losing federal funding[1][2].

4. Scope: The order primarily impacts high school, collegiate, and community sports[4].

5. International impact: The directive also affects professional athletics, urging officials to prevent transgender women from entering the U.S. for competitions and advocating for the International Olympic Committee to disallow transgender athletes in its events[1][4].

The Trump administration argues that this order is necessary to preserve fairness, safety, and opportunities for women in sports[1][4]. However, critics, including human rights organizations and LGBT advocates, have labeled the initiative as discriminatory[4].

This executive order represents a significant shift from the previous Biden administration’s stance, which had proposed regulations to protect LGBT students under Title IX[4]. The order has already influenced other organizations, with the NCAA announcing a new policy aligning with Trump’s executive order, prohibiting athletes assigned male at birth from competing in NCAA women’s competitions[5].

Citations:
[1] https://www.aljazeera.com/news/2025/2/7/whats-behind-trumps-ban-on-transgender-women-in-us-womens-sports
[2] https://www.nytimes.com/2025/02/05/us/politics/trump-trans-athletes-executive-order.html
[3] https://www.cnn.com/2025/02/05/politics/transgender-athletes-trump-executive-action/index.html
[4] https://www.bbc.com/news/articles/c20g85k3z35o
[5] https://ogletree.com/insights-resources/blog-posts/ncaa-bars-transgender-athletes-from-womens-sports-aligning-with-president-trumps-executive-order/
[6] https://www.cbsnews.com/news/trump-executive-order-banning-transgender-athletes-womens-sports/
[7] https://www.edweek.org/policy-politics/what-trumps-trans-athlete-ban-means-for-schools-and-states/2025/02
[8] https://abcnews.go.com/Politics/trump-sign-executive-order-banning-transgender-athletes-womens/story?id=118468478
[9] https://www.cbsnews.com/minnesota/news/mn-attorney-general-trans-athlete-ban-opinion/
[10] https://www.nbcnews.com/nbc-out/out-politics-and-policy/trump-upends-transgender-sports-landscape-stroke-pen-rcna192056
[11] https://www.npr.org/2025/02/05/nx-s1-5282137/trump-transgender-sports-executive-order
[12] https://www.mprnews.org/story/2025/02/20/ellison-says-trump-order-on-transgender-athletes-violates-minnesota-law
[13] https://apnews.com/article/donald-trump-transgender-athletes-3606411fc12efffec95a893351624e1b
[14] https://www.nbcnews.com/nbc-out/out-politics-and-policy/trump-executive-order-ban-trans-women-sports-rcna190767
[15] https://www.reuters.com/world/us/trump-administration-target-transgender-women-sports-white-house-says-2025-02-05/
[16] https://www.whitehouse.gov/presidential-actions/2025/02/keeping-men-out-of-womens-sports/
[17] https://www.washingtonpost.com/education/2025/02/05/transgender-students-trump-executive-order/
[18] https://www.npr.org/2025/02/21/nx-s1-5305108/trump-janet-mills-maine-transgender-athletes
[19] https://www.cnn.com/2025/02/22/us/maine-trans-athletes-trump/index.html
[20] https://www.house.mn.gov/sessiondaily/Story/18497

—
Answer from Perplexity: www.pplx.ai/share

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PBMs warn of low compliance for Part D claims with certain MPPP BIN/PCNs

Posted on February 20, 2025 by Pharmaciststeve

Apparently, this is something new that the Feds/CMS has implemented with Medicare Part D and Medicare -C ( Advantage). According to this article, it appears that the various PBM ( Prescription Benefit Managers) have not done much in educating Pharmacists/Pharmacies on how this is supposed to be handled in the billing of the pt’s prescriptions to the PBM on the pharmacy computer system.  According to the article the PBM’s customer service staff was not well trained either with the exception of training the CS staff to use this opportunity with the pt to try to get the pt to switch their Rxs to the PBM’s mail-order pharmacy. A quote from Obama’s first chief of staff seems to apply here “You never want a serious crisis to go to waste. And what I mean by that [is] it’s an opportunity to do things that you think you could not before”

what is MPPP in the Medicare Part D program?

The Medicare Prescription Payment Plan (MPPP) is a new program set to begin in 2025 as part of the Medicare Part D prescription drug coverage. This optional program allows beneficiaries to spread out their out-of-pocket prescription drug costs over the course of the plan year, rather than paying the full amount at the pharmacy when picking up medications12.

:

  • Available to all Medicare Part D enrollees, including those in Medicare Advantage plans with prescription drug coverage13

  • Voluntary opt-in program, not automatic enrollment13

  • Enrollment possible during Medicare Open Enrollment (October 15 – December 7, 2024) or anytime throughout the plan year1

:

  • Beneficiaries pay $0 at the pharmacy counter for covered Part D drugs13

  • Monthly bills from the Part D plan cover out-of-pocket costs, spread over the year13

  • Does not reduce total annual cost-sharing, only smooths payments over time2

:

  • Helps manage high out-of-pocket costs, especially early in the plan year15

  • Particularly beneficial for those expecting to reach the $2,000 out-of-pocket cap before December 13

:

  • Enrollees with high out-of-pocket costs early in the plan year15

  • Those facing OOP costs of $600 or more for a single medication25

:

  • Beneficiaries with low, stable out-of-pocket drug costs2

  • Those receiving cost-sharing assistance from programs like Extra Help, SPAP, or MSP2

:

  • Two-month grace period for missed payments2

  • Failure to pay may result in removal from MPPP and ineligibility for future enrollment25

It’s important to note that while the MPPP can help spread out costs, it does not lower the total annual cost-sharing for prescription drugs. Beneficiaries should carefully consider their individual circumstances and consult with their healthcare providers or Medicare counselors to determine if the MPPP is right for them5.

Citations:

  1. https://www.lung.org/getmedia/d10aa01a-efcc-4daf-88e2-5bb2298574a5/MedicarePrescriptionPaymentPlan_Infographic.pdf
  2. https://targethiv.org/library/faqs-medicare-prescription-payment-plan
  3. https://www.lung.org/policy-advocacy/healthcare-lung-disease/healthcare-policy/medicare/prescription
  4. https://www.mintz.com/insights-center/viewpoints/2146/2025-02-13-operationalizing-medicare-prescription-payment-plan-and
  5. https://avalere.com/insights/navigating-the-medicare-prescription-payment-plan-what-it-means-for-patients-and-patient-groups
  6. https://www.lls.org/article/get-informed-important-changes-medicare-part-d
  7. https://www.medicarerights.org/medicare-watch/2024/07/25/guidance-on-inflation-reduction-acts-medicare-prescription-payment-plan-released
  8. https://www.lungevity.org/blogs/what-you-need-to-know-about-changes-to-medicare-part-d-in-2025
  9. https://www.sanfordhealthplan.com/align/pharmacy-and-drug-coverage/medicare-prescription-payment-plan
  10. https://www.panfoundation.org/understanding-the-medicare-prescription-payment-plan/
  11. https://www.cms.gov/inflation-reduction-act-and-medicare/part-d-improvements/medicare-prescription-payment-plan
  12. https://www.medicare.gov/prescription-payment-plan
  13. https://www.medicare.gov/publications/12211-whats-the-medicare-prescription-payment-plan.pdf
  14. https://www.cms.gov/files/document/faqs-related-medicare-prescription-payment-plan.pdf
  15. https://www.humana.com/pharmacy/patient-assistance/medicare-prescription-payment-plan
  16. https://www.medicare.gov/prescription-payment-plan/before-payment-option
  17. https://avalere.com/insights/navigating-the-medicare-prescription-payment-plan-what-it-means-for-part-d-plan-sponsors

Answer from Perplexity: pplx.ai/share

PBMs warn of low compliance for Part D claims with certain MPPP BIN/PCNs

https://ncpa.org/newsroom/qam/2025/02/20/pbms-warn-low-compliance-part-d-claims-certain-mppp-binpcns

PBMs processing Medicare Part D claims have reached out to NCPA reporting low compliance for claims to the BIN/PCN that start with “MPPP…” when a patient is participating in the Medicare Prescription Payment Plan. If your pharmacy receives paid claim responses from Medicare Part D plans with Approved Message Code 057 Beneficiary participating in Prescription Payment Plan, you absolutely need to send a subsequent claim for the copay amount due to the Part D plan’s MPPP processor.

Patients may need additional information about the new program. Once they participate, all copays must be submitted to the MPPP processor. Patients who no longer wish to participate should contact their plan. Contact your pharmacy management system right away if you don’t know how to check for Approved Message Code 057, or where to look to find the MPPP processing information in the COB/Other Payer segment. For more information on the MPPP, including a continuing education program for pharmacists and pharmacy technicians, go to https://ncpa.org/medicare.

NCPA has also heard from members that Part D plan member hotlines are providing confusing information about MPPP and are also using the encounter to steer patients into mail order from an affiliated mail-order pharmacy.

Click here for tips on making formal complaints to Medicare.

Filed under: General Problems | 1 Comment »

A TEN BILLION DOLLAR a year mostly unnecessary,ineffective and possible harmful medical procedure

Posted on February 20, 2025 by Pharmaciststeve

This is going to be a fairly long post, I intend to make a post to @DOGE on “X” about what most chronic pain pts would agree is a TEN BILLION DOLLAR waste of money. But all of this information is TOO LONG to fit in a single post on “X”. If you are a pt that your pain doc is telling you… no Rx for pain meds unless you submit to ESI (Epidural Spinal Inj). They can only charge $100-$200 for an office visit for prescribing oral pain meds but giving you ESI – according to this information – will generate ~ $4,000 for the practice. Another sign that healthcare is nothing more, nothing less than a FOR PROFIT BUSINESS.

Those $$ seem quite low – my question was for specifically epidural SPINAL injection, the $$$ that you stated was probably for general IM injections of corticosteroid – like depo-medrol

You’re correct, and I apologize for the confusion in my previous response. Let me provide more accurate information specifically for epidural spinal injections of corticosteroids:

## Cost of Epidural Spinal Injections

The cost of epidural spinal injections for corticosteroids is indeed higher than general intramuscular injections. Here’s a more accurate breakdown:

– **Average Cost per Injection**: Approximately $1,000 in 2025[1].

– **Total Cost for Multiple Sessions**: Around $4,000 or more, as multiple injections are often necessary[1].

## Factors Affecting Cost

Several factors can influence the cost of epidural spinal injections:

1. **Location**: Costs can vary depending on where you live and where the procedure is performed (e.g., doctor’s office vs. hospital)[1].

2. **Insurance Coverage**: For patients with insurance, including Medicare, out-of-pocket costs may be lower[3].

3. **Number of Injections**: Multiple sessions are often required, which increases the overall cost[1].

4. **Additional Services**: The total cost may include the office visit, medical imaging (such as X-rays or CT scans), and the procedure itself[1].

## Medicare Billing

It’s worth noting that Medicare has specific guidelines for covering epidural steroid injections:

– Medicare improperly paid physicians $3.6 million for epidural steroid injection sessions that exceeded coverage limitations during a two-year audit period from 2019 to 2020[2].

– Medicare limits epidural steroid injections to a maximum of four sessions per spinal region during any 12 months[3].

## Billing Codes

The most common CPT codes for epidural steroid injections are:

– 62320-62323: Injection of diagnostic or therapeutic agent, interlaminar epidural or subarachnoid[5].
– 64479-64484: Injection of anesthetic agent and/or steroid, transforaminal epidural[5].

In conclusion, the cost of epidural spinal injections for corticosteroids is significantly higher than general intramuscular injections, with an average cost of around $1,000 per injection and potentially $4,000 or more for a full course of treatment.

Citations:
[1] https://expresslegalfunding.com/epidural-steroid-injections-cost/
[2] https://oig.hhs.gov/reports/all/2023/medicare-improperly-paid-physicians-for-epidural-steroid-injection-sessions/
[3] https://scottglovsky.com/insurance-bad-faith/health-claim-denial/steroid-injections/
[4] https://www.oregon.gov/oha/HPA/DSI-HERC/EvidenceBasedReports/CG-Low-Back-Pain-Corticosteroid-Injections-4-20-17.pdf
[5] https://www.hcfraudshield.com/spinal-injection-pain-in-the-neck/
[6] https://www.healthnote.com/ensuring-accurate-billing-and-documentation-for-lumbar-epidural-steroid-injections/
[7] https://emedicine.medscape.com/article/325733-overview
[8] https://guidelines.carelonmedicalbenefitsmanagement.com/interventional-pain-management-2024-06-30/
[9] https://sesamecare.com/blog/how-much-does-a-cortisone-injection-cost
[10] https://www.acpjournals.org/doi/10.7326/M15-0934
[11] https://www.caresource.com/documents/marketplace-ky-policy-reimburse-py-1051-20191218.pdf
[12] https://www.paintreatmentspecialists.com/does-insurance-cover-back-pain-injections/
[13] https://www.anesthesiallc.com/publications/anesthesia-provider-news-ealerts/1464-special-alert-anesthesia-for-epidural-steroid-injections-in-jeopardy
[14] https://pubmed.ncbi.nlm.nih.gov/23953016/
[15] https://cost.sidecarhealth.com/ts/epidural-steroid-injection-cost-by-state
[16] https://www.medicare.gov/procedure-price-lookup/cost/64483/
[17] https://www.molinahealthcare.com/-/media/Molina/PublicWebsite/PDF/Providers/wa/Medicaid/resource/mcp/MCP-032-Epidural-Steroid-Injections-for-Chronic-Back-Pain.pdf
[18] https://cost.sidecarhealth.com/n/epidural-steroid-injection-cost
[19] https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39054&ver=11
[20] http://mcgs.bcbsfl.com/MCG?mcgId=02-61000-31&pv=false
[21] https://www.desertspineandsports.com/cash-pricing/
[22] https://www.medicare.gov/procedure-price-lookup/cost/62287
[23] https://www.molinahealthcare.com/providers/sc/medicaid/PDF/Epidural-Steroid-Injections-for-Chronic-Back-Pain-MCG-032.pdf
[24] https://www.ohsu.edu/sites/default/files/2019-04/Epidural-Steroid-Injections-Medications-and-Dosages.pdf
[25] https://pmc.ncbi.nlm.nih.gov/articles/PMC7145384/
[26] https://hssh.health/blog/15-types-of-injections-for-back-pain/
[27] https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58777&ver=11
[28] https://myhealth.alberta.ca/Health/pages/conditions.aspx?hwid=abk1059
[29] https://www.osc-ortho.com/blog/debunking-myths-about-epidural-steroid-injections-esis-in-the-lumbar-spine/
[30] https://www.aetna.com/cpb/medical/data/1_99/0016.html
[31] https://caringmedical.com/prolotherapy-news/epidural-steroid-injections/
[32] https://www.prolianceorthopedicassociates.com/spinal-injections-what-you-need-to-know
[33] https://pmc.ncbi.nlm.nih.gov/articles/PMC4410617/
[34] https://www.aapc.com/discuss/threads/is-an-in-office-injection-considered-prescription-drug-management.191241/
[35] https://www.nhs.uk/conditions/steroid-injections/
[36] https://www.palmettogba.com/palmetto/jjb.nsf/DID/SSLAIT1XNR
[37] https://www.caresource.com/documents/marketplace-ga-policy-reimburse-py-1127-20200626
[38] https://asipp.org/wp-content/uploads/Table-1.-2022-Physician-Proposed-Payment-Rates.pdf
[39] https://pmc.ncbi.nlm.nih.gov/articles/PMC8360670/

Answer from Perplexity: pplx.ai/share

Can you determine the gross $$ per year for epidural spinal injections of corticosteroid

Based on the search results, we can calculate the gross revenue per year for epidural spinal injections of corticosteroids:

## Calculation

– Number of injections per year: 10 million[3][5]
– Average cost per injection: $1,000

Gross revenue = Number of injections × Average cost per injection
$$ 10,000,000 \times \$1,000 = \$10,000,000,000 $$

## Result

The gross revenue per year for epidural spinal injections of corticosteroids is approximately $10 billion.

## Additional Context

It’s important to note that:

1. This figure represents the total amount billed, not necessarily the amount paid out by insurance companies or patients.

2. The number of injections has been increasing over time. From 2000 to 2014, there was a 99% increase in overall epidural injections per 100,000 Medicare beneficiaries, with an annual increase of 5%[4].

3. Different types of epidural injections have shown varying trends. For example, lumbosacral transforaminal epidural injections increased by 609% from 2000 to 2014, with an annual increase of 15%[4].

4. Despite the high number of injections, there is ongoing scrutiny of this procedure due to its varying effectiveness and potential risks. The FDA has required label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections[2].

5. The effectiveness and safety of these injections continue to be subjects of research, with efforts being made to better identify patients who are most likely to benefit from the procedure[5].

Citations:
[1] https://www.painphysicianjournal.com/current/pdf?article=NzAyNg%3D%3D&journal=125
[2] https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-requires-label-changes-warn-rare-serious-neurologic-problems-after
[3] https://pmc.ncbi.nlm.nih.gov/articles/PMC7379698/
[4] https://pmc.ncbi.nlm.nih.gov/articles/PMC5168679/
[5] https://www.hopkinsmedicine.org/news/newsroom/news-releases/2023/02/rapid-screening-test-predicts-effectiveness-of-steroid-injections-for-neck-pain
[6] https://pmc.ncbi.nlm.nih.gov/articles/PMC9296573/
[7] https://my.clevelandclinic.org/health/treatments/22301-epidural-steroid-injection-esi
[8] https://www.ncbi.nlm.nih.gov/books/NBK537320/
[9] https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39015&ver=12
[10] https://academic.oup.com/painmedicine/article-abstract/19/7/1299/5003355
[11] https://emedicine.medscape.com/article/325733-overview
[12] https://comprehensivespine.weillcornell.org/about-us/publications/transforaminal-epicural-steroid-injections/
[13] https://www.hss.edu/conditions_epidural-injections-faqs.asp
[14] https://cdn.ymaws.com/www.ipsismed.org/resource/resmgr/factfinder/factfinder_2019_06_annual_do.pdf
[15] https://my.clevelandclinic.org/health/treatments/22091-lumbar-epidural-steroid-injection
[16] https://www.westernreservehospital.org/blog/minimally-invasive-interventions-persistent-back-pain
[17] https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam-assets/690%20Epidural%20Steroid%20Injections%20for%20Neck%20and%20Back%20Pain%20prn.pdf
[18] https://academic.oup.com/painmedicine/article-abstract/20/10/2069/5555353
[19] https://hssh.health/blog/the-dark-side-of-epidural-steroid-injections-risks-complications/
[20] https://www.medcentral.com/pain/chronic/how-safe-epidural-steroid-injection-examining-drug-related

Answer from Perplexity: pplx.ai/share

Has the FDA approved corticosteroids be given via the ESI route

The FDA has not approved corticosteroids for epidural injection. This lack of approval has been consistently maintained despite the widespread use of epidural steroid injections (ESIs) for treating back and neck pain.

Key points regarding the FDA’s stance on corticosteroids for epidural use:

1. **No FDA Approval**: The FDA has not approved any corticosteroids for epidural administration[1][5][8].

2. **Safety Warning**: In April 2014, the FDA issued a warning about the risks associated with injecting corticosteroids into the epidural space[2][5].

3. **Label Changes**: The FDA required the addition of a warning to the drug labels of injectable corticosteroids to describe the risks associated with epidural use[5].

4. **Lack of Established Safety and Effectiveness**: The FDA has stated that the effectiveness and safety of corticosteroids for epidural use have not been established[1][4][5].

5. **Advisory Committee Meeting**: In November 2014, the FDA convened an Advisory Committee meeting to discuss the benefits and risks of epidural corticosteroid injections[4][8].

6. **Ongoing Use Despite Lack of Approval**: Despite the FDA’s position, ESIs have been widely used for decades, with numerous studies demonstrating their efficacy and safety in certain patient populations[6][8].

It’s important to note that while the FDA has not approved corticosteroids for epidural use, they continue to be commonly utilized in clinical practice for treating various spinal conditions. Patients should discuss the potential benefits and risks of ESIs with their healthcare providers, considering alternative treatment options as well.

Citations:
[1] https://pubmed.ncbi.nlm.nih.gov/25054397/
[2] https://jamanetwork.com/journals/jama/fullarticle/1874492
[3] https://www.providencehealthplan.com/-/media/providence/website/pdfs/providers/medical-policy-and-provider-information/medical-policies/mp14.pdf
[4] https://www.apsf.org/article/fda-issues-drug-safety-communication-about-epidural-corticosteroid-injections/
[5] https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-requires-label-changes-warn-rare-serious-neurologic-problems-after
[6] https://journals.lww.com/clinicalpain/fulltext/2021/09000/safety_of_epidural_steroid_injections_for.9.aspx
[7] https://www.medcentral.com/pain/chronic/how-safe-epidural-steroid-injection-examining-drug-related
[8] https://pmc.ncbi.nlm.nih.gov/articles/PMC8360670/
[9] https://dcoadmv.com/epidurals/
[10] https://www.fda.gov/media/184938/download
[11] https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011757s119lbl.pdf
[12] https://www.drugs.com/news/do-steroid-shots-help-ease-back-pain-experts-weigh-123724.html
[13] https://rapm.bmj.com/content/46/3/203
[14] https://www.nature.com/articles/d43747-020-00194-1.pdf
[15] https://associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.14804
[16] https://www.painphysicianjournal.com/current/pdf?article=MjEyMg%3D%3D&journal=83
[17] https://www.uhcprovider.com/content/dam/provider/docs/public/policies/oxford/epidural-steroid-facet-injections-spinal-pain-ohp.pdf
[18] https://www.painmedicineconsultants.com/blog/am-i-a-candidate-for-an-epidural-find-relief-from-chronic-pain
[19] https://www.fda.gov/drugs/safe-use-initiative/safe-use-initiative-completed-projects
[20] https://jamanetwork.com/journals/jama/fullarticle/2213785

Answer from Perplexity: pplx.ai/share

Does the pharma that makes Depo-medrol suggests that it be used in ESI

Pfizer, the manufacturer of Depo-Medrol (methylprednisolone acetate), explicitly advises against using the drug for epidural steroid injections (ESI). Here are the key points regarding Pfizer’s stance on Depo-Medrol for ESI:

1. **Not Recommended**: As early as 1995, Pfizer (then Pharmacia & Upjohn) stated in internal documents that they had received reports of severe medical events associated with epidural injections of Depo-Medrol[1].

2. **Package Insert Warning**: Pfizer initially included a warning in the package insert stating that “epidural administration of Depo-Medrol is NOT RECOMMENDED”[1].

3. **Contraindication in Some Countries**: In Australia and New Zealand, Pfizer has contraindicated Depo-Medrol for epidural administration. Their revised data sheet includes a Black-Box Warning stating: “Depo-Medrol MUST NOT be used by the epidural route” due to reports of “serious medical events”[2].

4. **US Labeling**: While the US labeling does not explicitly contraindicate epidural use, it does not recommend or approve it either. The US data sheet lists severe adverse events for both intrathecal and epidural routes of administration[2].

5. **FDA Stance**: The FDA has not approved any corticosteroids, including Depo-Medrol, for epidural administration[2][4].

6. **Off-Label Use**: Despite these warnings and lack of approval, Depo-Medrol continues to be widely used off-label for epidural injections to treat chronic neck and back pain[1][4].

7. **Recent Developments**: As of 2025, Pfizer’s official product information for Depo-Medrol does not include epidural administration in its list of approved routes of administration or indications[6].

In conclusion, Pfizer, the manufacturer of Depo-Medrol, does not suggest or endorse its use for epidural steroid injections. On the contrary, they have explicitly warned against this practice in some countries and have not sought FDA approval for this use in the United States.

Citations:
[1] https://www.bmj.com/rapid-response/2011/10/30/esis-depo-medrol-efficacy-amp-safety-issues
[2] https://downloads.regulations.gov/FDA-2013-N-1523-0007/attachment_1.pdf
[3] https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011757s119lbl.pdf
[4] https://www.advisory.com/daily-briefing/2018/08/17/injection
[5] https://vancouverdisccenter.com/epidural-steroid-injections-are-the-risks-worth-the-benefits/
[6] https://www.medicines.org.uk/emc/product/8957/smpc
[7] https://labeling.pfizer.com/ShowLabeling.aspx?id=1120
[8] https://www.umms.org/rehab/health-services/pain-management/treatments/epidural-steroid-injections
[9] https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-requires-label-changes-warn-rare-serious-neurologic-problems-after
[10] https://www.hss.edu/conditions_epidural-injections-faqs.asp
[11] https://www.painphysicianjournal.com/current/pdf?article=MjEyMg%3D%3D&journal=83
[12] https://emedicine.medscape.com/article/325733-overview
[13] https://www.pfizermedicalinformation.com/depo-medrol-single-dose-vial/warnings
[14] https://jamanetwork.com/journals/jama/fullarticle/2213785
[15] https://pmc.ncbi.nlm.nih.gov/articles/PMC8360670/
[16] https://www.apsf.org/article/fda-issues-drug-safety-communication-about-epidural-corticosteroid-injections/
[17] https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam-assets/690%20Epidural%20Steroid%20Injections%20for%20Neck%20and%20Back%20Pain%20prn.pdf
[18] https://labeling.pfizer.com/showlabeling.aspx?id=550
[19] https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=36920
[20] https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/epidural-steroid-injections-spinal-pain.pdf

Answer from Perplexity: pplx.ai/share

are there any clinical studies that would indicate that injecting corticosteroids via the ESI route in the spine actually increase the deterioration of certain areas of the spine. Which could in the long term, cause the pt to have increased pain

Yes, there are clinical studies that suggest epidural steroid injections (ESIs) in the spine may lead to increased deterioration in certain areas and potentially cause long-term increased pain for patients. Here are the key findings:

## Negative Long-term Outcomes

A study published in 2013 found that patients with spinal stenosis who received ESIs had significantly less improvement at four years follow-up compared to those who did not receive ESIs[3]. This was true for both surgical and non-surgical patients:

– Surgical patients who had ESIs showed less improvement in physical functioning.
– Non-surgical patients who had ESIs experienced less improvement in both pain and functioning.

## Potential for Spinal Injury

ESIs can potentially cause further injury to the spine over time[2]:

– Repeated injections can weaken bones and increase the risk of fractures.
– ESIs may impair the spine’s ability to heal or regenerate tissue.
– The injections can mask or exacerbate underlying causes of back pain, such as poor posture or spinal misalignments.

## Lack of Long-term Benefits

A 2022 study on older adults with new episodes of back pain found that while patients treated with ESI showed long-term improvement, this improvement was unlikely to be a result of a specific ESI effect[6][7]. The study concluded that older adults with new episodes of back and leg pain are unlikely to experience long-term benefits from ESI.

## Increased Surgical Complexity

For patients who eventually require surgery, prior ESI treatment may complicate the procedure[3]:

– Surgery took about half an hour longer for patients who had received ESIs.
– ESI patients spent about one day longer in the hospital post-surgery.

## Masking Underlying Issues

ESIs can potentially mask the underlying causes of pain, which may lead to delayed appropriate treatment and possibly worse outcomes in the long term[2]. By numbing nerves and reducing awareness of the body’s signals, ESIs might allow further deterioration to occur unnoticed.

While these studies suggest potential long-term negative effects of ESIs, it’s important to note that more research is needed to fully understand the long-term impacts. The decision to use ESIs should be made on a case-by-case basis, weighing the potential short-term benefits against possible long-term risks.

Citations:
[1] https://emedicine.medscape.com/article/325733-overview
[2] https://nervediscinstitute.com/blog/the-risks-and-side-effects-of-epidural-steroid-injections/
[3] https://www.wolterskluwer.com/en/news/steroid-injection-may-lead-to-worse-outcomes-in-patients-with-spinal-stenosis
[4] https://www.uhcprovider.com/content/dam/provider/docs/public/policies/oxford/epidural-steroid-facet-injections-spinal-pain-ohp.pdf
[5] https://pubmed.ncbi.nlm.nih.gov/21392252/
[6] https://pubmed.ncbi.nlm.nih.gov/35604636/
[7] https://pmc.ncbi.nlm.nih.gov/articles/PMC9296573/
[8] https://pmc.ncbi.nlm.nih.gov/articles/PMC3401142/
[9] https://rapm.bmj.com/content/46/3/203
[10] https://pmc.ncbi.nlm.nih.gov/articles/PMC7508264/
[11] https://academic.oup.com/painmedicine/article/12/5/726/1909636
[12] https://www.vertosmed.com/when-epidural-steroid-injections-esis-dont-provide-lasting-relief/
[13] https://my.clevelandclinic.org/health/treatments/22301-epidural-steroid-injection-esi
[14] https://www.painphysicianjournal.com/current/pdf?article=Nzc4&journal=31
[15] https://academic.oup.com/painmedicine/article/19/3/569/4783111
[16] https://academic.oup.com/rheumatology/article/44/11/1399/2891486
[17] https://www.aafp.org/pubs/afp/issues/2022/0700/fpin-hda-epidural-steroid-injections-low-back-pain.html
[18] https://www.anesth-pain-med.org/upload/pdf/apm-21002.pdf
[19] https://www.vertosmed.com/the-downside-of-repeat-epidural-steroid-injection-treatments-for-lumbar-spinal-stenosis/
[20] https://www.spine-health.com/treatment/injections/epidural-steroid-injection-pain-relief-success-rates

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