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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