Opinion: The Pain Industry’s New & Dangerous FALL-BACK

Opinion: The Pain Industry’s New & Dangerous FALL-BACK

By Dennis J. Capolongo / Director ENDC.

From my perspective, preventative measures to reduce iatrogenic harm should be among the list of alternatives to help reduce opioid consumption. Recently published reviews authored by outspoken physicians Dr. Martin Makary of John’s Hopkins and Dr. Jana Friedly of the U.W. Medical Center have pointed a finger at an industry that has literally run amok. They describe an ever increasing marketing trend that aggressively pushes for needless but lucrative surgeries and other complex procedures that often results in an ever widening path of pain and destruction in their wake.

Up until recently, opioid regiments were the official fall-back treatment plan for post procedure pain. It stands to reason that any increase in business, legitimate or not, will proportionally result in a greater number of medical errors. These botched medical procedures by doctors who are often in denial about what they had just done would routinely prescribe heavy opioid dosages while crossing their fingers with regards to their patients final outcomes. Speak to anyone who has been diagnosed with FBSS (Failed Back Surgery Syndrome) and you’ll get a clearer picture as to how these poor souls were mistreated by a system with very little, if any accountability.

With opiates falling under greater scrutiny, it begs the question, what will these doctors do now without their opioid fall-back plan? They’re not going to slow down their surgical and procedural schedule, no way!  Instead, they have made a deal with Congressional leaders and the FDA to exploit the opioid crisis as a bargaining chip to increase business even further, a crisis they are partially responsible for apparently by performing many unnecessary surgeries and procedures.

As early as 2012, pain physician societies such as ASIPP and others started lobbying Washington to allow them to use Epidural Steroid Injection (ESI) therapies (what we believe is a high risk and low efficacy invasive procedure) as their NEW FALL-BACK to manage pain from botched surgeries and related procedures. However they first needed to overcome a few obstacles to get their plan up and running.

The regulations in President Obama’s ACA (the Affordable Care Act) had reduced reimbursements for ESI therapies; (due to their poor efficacy rating) while the treatments now fell under a performance-based payment structure where poor outcomes would reduce their pay even further. So they needed something to reverse these money losing requirements even though it would have saved tax payers and the Federal Government millions of dollars every year while helping reduce preventable harm to vulnerable patients by aggressive clinics and hospitals.

About this time, the opioid crisis had taken the political news agenda by storm. So the interventional pain societies took advantage of this stroke of luck. They decided to not only push Congress to defeat the ACA in order to fully restore their ESI reimbursement schedule but to allow them to use more expensive Epidural Steroid Injection therapies as their NEW FALL-BACK to botched surgeries and procedures in lieu of opioid regimens!

It was a win-win perfect storm as ignorant politicians flocked to their side of the argument handing them the means to potentially do more harm than good while nearly doubling their income at the same time. (See; Congressional Bill H.R. 5804: Post-Surgical Injections as an Opioid Alternative Act)

My biggest fear is that this Bill, if passed, will eventually create an even greater problem to vulnerable patients as ESI’s continue to fall from favor due to their low efficacy and high risk status. Harm from ESI’s is exponentially growing along with their increased use, and in some cases necessitates life-long opioid treatments of some kind from intrathecal pump implants to multi-dose managed oral intake.

It should be noted that back in 2013, the FDA’s Safe Use Initiative Team (SUI) recommended the agency investigate the ever growing reports of severe harm from ESI treatments that were now flooding the agency’s MedWatch alert database, especially after the fungal meningitis outbreak had killed many people the previous year. So in 2014, the FDA appointed an advisory panel to do just that.

Thanks to the advocates and families who presented to the FDA’s AADPAC advisory panel in 2014, they voted 15-7 to Contraindicate (ban) ESI’s at the C level, and to post new strict Warnings on the labels of all injectable steroids when used via the epidural route. How ironic since Upjohn (the originators of the steroid Depo-Medrol®) were angrily writing the FDA to “alert the medical community” to the dangers of this unapproved procedure since 1988!  It took 26 years for the agency to finally take notice and yet they sadly rejected their advisory panel’s recommendation.

Unfortunately for them and their physician industry collaborators Pfizer Global, the makers of the most popular ESI steroid Depo-Medrol® (Methylprednisolone Acetate) is now asking the FDA to “Contraindicate” their product “for epidural administration” (at all levels) in their Global-Core-DataSheet for the drug due to increasing reports of severe harm and death. Pfizer is also requesting for a “MUST-NOT USE via the epidural route” Black-Box Warning to further drive their point that this drug is dangerous when used in this unlicensed way.

Sadly, the FDA has unlawfully rejected Pfizer’s request. In fact they have repeatedly rejected these and other numerous calls to alert the general public along with the medical establishment despite multiple interventions by drug manufacturers, FDA advisory panels, SUI teams, concerned physicians and patient advocacy groups.

So why has the FDA rejected these important safety warnings from Pfizer Global, the world’s largest drug manufacturer and others? What is their motive? Did they cave to industry and political pressure for all the reasons stated above or do they care less about their prime directive for public safety and more about keeping Wall Street and Congress happy?

Without any procedural oversight of the pain management industry, and without any strict regulations to help prevent aggressive marketing for needless but lucrative surgeries and procedures, especially with an FDA that’s embedded by industry insiders, I fear this mess will only get worse before it gets better. Preventable harm can be achieved, but it will come at a cost to their bottom line, something I fear they will never allow. The evidence is clear, the FDA is obviously placing the interests of the Pain Management Industry, a $300Billion* dollar a year behemoth above public safety.

In this advocates opinion, they will all eventually be held accountable. God help us if H.R.5804 passes.

To learn about the legislation, click here.

*12/28/2011 Bloomberg Business / David Armstrong

The EDNC is a patient advocacy collaborative comprised mostly of business professionals who believe they were seriously harmed by the off-label epidural administration of Pfizer’s Depo-Medrol and other similar steroid suspensions. As patient advocates, they work on behalf of those whose lives have been seriously affected from the severe adverse effects of intraspinal procedures and therapies. Dennis Capolongo has been its Director since 2002.

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Authored by: Dennis J. Capolongo

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Mavis Johnson

It is kind of late now. The FDA will side with whichever Industry Group has the most influence or paid the most money. Welcome to the Kleptocracy folks. Our Senators don’t give a darn, they have been pocketing money form both sides. They are even cashing in on Incarcerating Children. If they would lie to our Veterans, and mislead the American public for profit, there really is not much they would not do for a fast buck. This country is seeing the end of Democracy, the only real question should be who will they come for next. they don;t care about sick people, let alone pain patients. They did not even care about pregnant women dying.
This is the New World Oder people. They had to make up an excuse for all of those displaced workers, broken down big box store employees, and hard working Americans they are denying healthcare, employment benefits and even their very dignity. We don’t need another silly non profit, operating long enough to get corporate funding, that was the heart of the problem. There are lots of sites like this one. Their only agenda is to mislead us all into a false sense of complacency , and sell us products. In the meantime they peddled everything from Chiropractors, to coffee enemas, useless and unscientific but apparently better than nothing.

Judy

Great article!!!
25+ years of living with chronic back pain and there’s 2 things I’ve learned early on:
1st: Back surgery should be a LAST resort, not a first choice. I’ve not had back surgery, but my brother has had 3 failed back surgeries. I’m not willing to risk it.
2nd: ESI’s don’t work for most people, at best they may offer some short-term, short-lived relief. I’ve had ESI therapy more than once & it did nothing for me.
What those who don’t suffer from chronic pain don’t realize is THERE’S NO CURE, only treatment. The best most effective treatments to MANAGE chronic pain are opioids and medical marijuana, unfortunately those aren’t options available to most chronic pain patients.

Terri Lewis

https://www.congress.gov/bill/115th-congress/house-bill/5804/text

Call your Senators. This Act facilitates the forcing out of injections which are not approved by FDA and steroids not approved for injection into the intrathecal space. Not good for me or you, your grandma, your babies, anybody you love.

Alan Edwards

Politicians are now pain specialists. The government is in control of the entire healthcare system. Hopefully, H.R. 5804 will not pass. However, opioids are the best treatment for post-surgical pain bar nothing. Medrol and other steroids have been used intrathecally for spinal disease pain for over two years to replace opioids ENTIRELY due to the CDC, FDA, and DOJ’s war. I am tired of the half century struggle which may end my life and many others. I received about four Tylenol post-surgery 45 years ago. Is that to be the newest fallback?

Veterinarians used to start pets on opioids BEFORE they awoke post-surgery after car strikes. That was sound medicine.

I just left phusical rehab a stroke 61yrs my pain an high blood presser finaly got me after 2yrs with no treatment because my drs abandoned me.i even had a dr place a hand on my arm an declare I do not have rsd that I have had since 1988 I told him he should get a tent and go on the faith healing circet hence 2weeks for lost right side an speech the powers that be will let use die than admit we exsit.

Notasheep

Been saying this about epidurals for years.

Yep, from back surgeries to epidurals that resulted in FBS and adhesive arachnoiditis, this is my story. Although to be honest, the surgeries were necessary to stabilize my spine. Kept breaking the screws(,ok, those suckers are bolts!) with the last surgery only correcting to grade 2 spodylolisthesis. from grade 4. Pain has kept me from breaking the last instrumentation with activity. Country, what can I say?

Dee

Amen Bob! It is a fact that surgeons are the cause of some of the chronic pain people are suffering from. They quit looking at the individual and perform assembly line surgeries treating EVERY patient like the next, whether their herniated disc, etc. may have been different from the patients before. And they also do not keep up with techniques that keep THAT surgery from turning into a failed one. Surgeons should start being held accountable for the work they are doing. If you go to a mechanic and he screws up your car, he has to pay for it. Or fix it until it is done right or he gets fired. How is surgery any different?

Deborah M Babcock

My question is this..
What about the war on methamphetimine ? It surly is way worse than OPIOIDS!! So,with that being said…should we ban all the ADHD medications out there because of the misuse of them by the very type of people who would abuse pain medication !! The handful of drug addicts abusing medication is the reason why we legitimate pain patients cannot get the medicine we need.? But those same people can get methadone or anything else they assumably need.. ? What about the war on meth addicts !!!???

R Ward

I had a FBSS an this is more insanity caused by a trumped up war against CPPs, The Drs that help us as well .. when will this fed give stop practicing media wotrhiut a license..!!! The guidelaws were made to have just his effect .!! This was not on accident.. an I do believe it’s a coordinated effort into kill as many of us as they can . They started this trial with out Vetrans an kool how that’s worked .now suicide is the number one cause Of death.. an the reason seems obvious.. I had a FBSS myself an numerous other problems an rely on Meds . They don’t ever take the pain away completely but it did allow me to have a semblance of life and now since these barbaric bs guidelines Inow been reduced to a bedridden cripple .. unable to care for myself drive take care f or even walk my dog. If I can get out of bed i to make it to the bathroom it’s a good day . If this is not fixed I fear the bodies will continue to pile up and more junkies will be created because of CPPs being forced to the street to seek relief .. an more important Untreated Chriin Pain will kill in and of itself .. were all adults if we choose to take a Med we also take the side effects .. addiction and dependence are two very different things and the CPP community an Drs that help th m should not have been an never should be f****kd with !! Really appreciate these articles .. keep up ur great work on getting his info out.. iat least some people still have a heart and know what the real cause of this Fentynal crisis. Let’s keep screaming protesting and doing all we can .. this is our lives we’re fighting for .

Mary

Very valuable points regarding H.R.5804 and the dangers of ESI.
More untreated post-surgery pain awaits patients.

Rachel

When my Chronic Pain was diagnosed my Consultant Phsyician, the head of rehabilitation at a leading UK orthopaedic hospital, he told me he gets most of his patients withchronic pain treatment from back surgeries, DONT HAVE BACK SURGERY!

Alan Edwards

Being the only 3 pound infant in an incubator in late 1962 should have given my parents hope that iatrogenesis would not occur. I was the only child at the time in the ward. And no it was not the stone age. My vitals were remotely monitored- but I was not swaddled or held and my parents left me eventually to work. The nurses and doctors knew I needed bottled oxygen for my under-developed lungs. FDA guidelines thought of wrongly as law said no. Blindness. That action, lead to brain damage, pneumonia, complex cerebral palsy and a year of suffering that I cannot imagine. The lack of touch, or tactile care, led me to become extremely shy. I am among the 280,000 people harmed by medical professionals each year in th U.S.
in every way imaginable including being forced into poverty- caused by the most expensive, regulated medical system in the world. It started with the creation of government acronyms. The Fda around 1914 and the controlled substances act in 1971- when I was given valium for spasticity.
Now I am in pain and lame without crutches. Some oral analgesics are effective.
Oral Methylprednisolone is one. The pain clinic won’t prescribe it in lieu of profitable, intrathecal Methylprednisolone which is less effective if one has extensive arthritis. They claim it causes osteoporosis. Not likely according to studies and a 55 year history. Opioids and oral Methylprednisolone had proven themselves, in conjunction with Ultram, to turn my intractable condition, into an almost painless, functional condition. Work and productivity were possible. Now both are being taken away by the government acronyms. My wallet is empty, my health is in decline, and I’m floundering. But not the pharmacists, physical therapy providers, pain doctors, referring doctors, and politicians!

Despite being an advocate for suffering, intractable pain patients, I no longer think we will win. We are outnumbered. Please go to You Tube. Enter Keywords “other side of the opioid crisis”. Forest Tenant, Mark Ibsen and other patient advocates are featured in many recent, fairly accurate, local newscasts from Nevda.

The intractable pain patient can understand this crisis on a level no one else can.

Many are at death’s door with no money for a casket and hear “But please take 23 rounds of physical therapy and these cortisone injections. And please comply with these dangerous, ineffective, expensive modalities, and drug prescriptions.” How many others have heard this?

Nonya

Those injections are a total joke! I have been through 7 rounds of them through the years, and they never even touched my pain! It’s a shame, I really wanted them to work…The Government Agencies really need to get out of medicine and let doctors do there job! This is all driven by”hysterical” news and terribly over inflated numbers, and of course, MONEY!

Maureen M.

I love this post! It is greatly related to my pain issues and gives me confirmation on my own thoughts, conclusions and research. I had my 1st lumbar spine fusion in 1992/San Diego which was done via an 8 inch incision along my left flank/side. The bone was taken from my fibula/lower leg! This procedure was very unconventional and left me in spine chronic pain and CRPS at my left hip, thigh and foot. I swore I would never ever have another spine surgery!!!
But, there I was in 2005 after an auto accident (not my fault) warranted an extensive Anterior and Posterior repair of the fusion, laminectomy, instrumentation etc etc (the usual!).
That bone was both cadaver and manufactured.
Once again, I was ignorant and followed my doctor’s lead. I was a 32 year career Nurse at that point and still trusting in doctors.
That surgery left me in worsened constant intractable pain and CRPS in my right lower leg and foot!
I became disabled within that post op year. 🙁 I could no longer work as a nurse ever again. I am in too much pain. That loss was devastating to me, and still is.

I must add, that both surgeries were preceded with Myelograms. Horrific!!!!!
Prison of war torture pain, to me! I still shudder at the thought of them.
Today, I believe that I have developed Adhesive Arachnoiditis from them plus many many many steroids injections over the years!
I began becoming ‘very ill systemically’ following the injections when having them as ‘therapy’ for pain every 3-4 months for 5 yrs!!! and therefore I finally got a clue and stopped ever having them again, 6 years ago. I need to be put out for them, getting them was excruciatingly painful for me, without anesthesia. I now know much more about those injections and its ill effects.
I have since developed Myalgic Encephalomyelitis… hmmm…related perhaps??

My 2005 lumbar hardware was pretty painful and I have not been able to sit but a few mins at a time, always with mega soft pillows under me, and never ever on a hard chair without a pillow! That will put me in bed for 2 days!
Hence in 2007, I ‘forced’ my surgeon to remove it. He was mad about that and purposely made it a very unpleasant experience for me (emotional stress for sure)! He was so nasty about it all. I have a whole other story about that abuse!

So yes, I am right on board with this author’s post!!!! I live it every day!

William Dorn

Is the government trying to kill us off. Are there no people in the government with any morals. I hope someone in congress will say this is wrong and fight for justice for pain patients. If not then satin rules our country and we are lost. I pray that GOD will protect all those in pain not just in America but all over the world. Everyone please pray for that one voice in congress that will help us.

I’m very disturbed that the CDC Unintentional Injuries Prevention Office have gone on record with the Opioid Prescribing Guidelines and said nothing about how to prevent the Injuries that create the pain that requires treatment. The policy is essentially backwards.

If unnecessary surgery is making pain worse, we should be preventing the unnecessary surgery.

David Harville

Your right!!! I have a failed back and this story is right on target!!

Dee

A family member of ours at the young age of 24 was forced to get an epidural steriod shot or the morphine implant or no more medicine. Well now he suffers from severe osteoporosis because they missed! It shot all through his body and his faced swelled and he turned purple and we had to rush him to emergency. These shots cause something called osteopenia anyway let alone if its done improperly. Plus all the side effects that can happen with it are not worth it.

Danny Scales

Leave opiates alone the government just keeps making it worse now people in chronic pain are using herion so they can have a life well most the herion is being brought into the state’s by the CIA just like in Vietnam the country’s herion was everywhere as it is now and we just happen to be in the opiate part of the world again and bam herion is everywhere let doctors do there job without the threat of loss of licence or even jail time