It is often said that the enemy of chiropractic and non-surgical spinal decompression, are epidural injections. We go into this in great detail at the National Certification program for non-Surgical Spinal Decompression this year, and it will be held in Atlanta, at Life University. Quite frankly, I never fully understood the dangers and the risks of epidural injections until I started teaching this program. There is more to know about Non-surgical Spinal Decompression than the machine. There must be an understanding of the disc, the associated research, there must be an understanding of the drugs that the medical profession utilizes, there must be knowledge of the many surgical procedures that are utilized for back pain. To be known as the best, you have to put in the time, this is not an ultrasound treatment. You don’t just put them on the machine, we are not Ron Popeil, we do not set it and forget it.
Epidurals and the FDA
The Food and Drug Administration (FDA) is the federal regulatory and enforcement agency responsible for ensuring safety in the food we purchase and consume, and the drugs and medical equipment we use to diagnose, prevent or treat injury and disease. Drugs must be tested, manufactured, and labeled in accordance with FDA standards before they can be sold or prescribed. Medical devices, such as pacemakers, hearing aids, x-ray machines, computerized tomography scanners, magnetic resonance imaging equipment, ultrasound instruments, and non-surgical spinal decompression machines, must also satisfy validity testing and efficacy standards testing under FDA oversight.
The FDA expressly grants or denies physicians permission to prescribe approved medications and diagnostic or therapeutic medical devices within their intended uses. The FDA also permits physicians to prescribe approved medications or medical devices for other than their intended and approved uses. Though such practices to me appear very suspect and unethical, yet many doctors see them as a necessary procedure to promote medical advances. The practice is known as off-label use.
How is this possible?
Epidural steroid injection has, over the years, become a common and lucrative procedure for the treatment of cervical and lumbar radicular pain, stenosis, spondylosis, disc herniation, and degenerative disc disease. The word epidural is composed of the prefix “epi,” meaning on or above, and the suffix “dural,” which refers to the dura mater. A corticosteroid is a hormone that acts as an anti-inflammatory. Accordingly, the steroid anti-inflammatory agent is injected near the spinal cord, but outside the surrounding membranes.
"Yet you will learn herein that the FDA has not approved the procedure or any drug for spinal injection to treat neck and back pain."
Notwithstanding, ESI today is a frequent and increasingly common procedure for the treatment of cervical and lumbar pain due to traumatic and degenerative conditions. Yet you will learn herein that the FDA has not approved the procedure or any drug for spinal injection to treat neck and back pain. Physicians - most commonly anesthesiologists and physiatrists - perform ESI off-label! Yet do the patients know this? Are they told this? I don’t think so. Have I caught your interest? It gets better.
On the FDA website it reads, “The U.S. Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. We require the addition of a warning to the drug labels of injectable corticosteroids to describe these risks. Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments.”
Facts about corticosteroids
“A class of drugs commonly used to reduce swelling or inflammation, injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone corticosteroids are not approved by FDA for injection into the epidural space of the spine.”
How crazy is it that a common procedure is not approved for back pain?
Now you know what to tell the patient when they tell you they are thinking about getting an epidural injection. Many MDs I have spoken with did not even know this. It’s our job to educate the masses on the dangers of Opioids and Epidurals as well as the risks of spinal surgery.
In light of the FDA making a strong statement warning that injection of the active medication in these shots, glucocorticoids, which is a class of corticosteroids—into the epidural space of the spine could result in rare but serious neurological problems, including loss of vision, stroke, paralysis, and death. Based on those and other findings, the Journal of the American Medical Association (JAMA) advised physicians to refrain from recommending injection therapy to patients with any kind of chronic back pain. It continues on a daily basis.
Anesthesiologist James Rathmell, the chair of the Department of Anesthesiology, Perioperative and Pain Medicine at Boston’s Brigham and Women’s Hospital, could go in with manageable low back pain symptoms and come out with catastrophic neurological injuries. “The bottom line,” said Rathmell, “is that if you come into my clinic with chronic axial back pain, you’re not going to get epidural steroid injections—because they don't work. The FDA had been issuing cautionary statements about epidural steroid injections since 1981. But in 2014, the agency took a further step, compelling pharmaceutical manufacturers that produced the injectable glucocorticoids to clearly state the risks on every vial’s label, advising that “serious neurologic events, some resulting in death, have been reported with epidural injection” and that the “safety and effectiveness of epidural administration of corticosteroids have not been established.”
Systemic glucocorticoid treatment in tablet form has long been recognized as a factor in bone mass loss, as well as a harbinger of increased risk of bone fracture. Although the FDA does not recommend oral steroids (methylprednisolone, prednisolone, and prednisone) for the treatment of any type of low back pain or sciatica, epidural steroid injections, which involve the same class of medication, have conventionally escaped scrutiny. At least that was true until 2012, when scientists at Michigan’s Henry Ford Health System, led by internal medicine specialist Shlomo Mandel, investigated the implications for bone health among women over the age of sixty-five who underwent epidural steroid injections. For each epidural steroid injection administered, the study found, the risk of suffering a vertebral compression fracture increased by 21 percent. Injected glucocorticoids adversely affected bone strength by diminishing new bone formation and increasing bone breakdown, in much the same way that the tablets did. In both cases, the end result was bone destruction.
There are two dominant techniques for administering epidural steroid injections. In the first, known as “interlaminar,” the needle is directed into the epidural space around the spinal nerves. In the second approach, referred to as “transforaminal,” the needle is inserted at an angle, which places it closer to the targeted nerve but also in the vicinity of vessels and arteries. Incorrectly placed, the needle can sever an artery or deliver medication into the blood vessels, clogging them and preventing adequate blood flow to the brain. The result, in either case, may be stroke or paralysis.
So doctors, would you take that risk? Will you allow or want your patients to take such a risk. Renown Orthopedic Surgeon Dr. Timothy Kremchek recommends Non-Surgical Spinal Decompression before having surgery or getting an epidural. The enemy today is greed. The greed of the pharmaceutical industry. So what do you do? You educate the patient. So in closing, I ask you this question, did you know before reading this article the epidurals are not approved by the FDA for back pain? If you did not know, how do you expect the patients or the public to know? Let’s get back to the basics, educating our patients is germane to end this atrocity.
Dr. Eric S. Kaplan, is President of DISC Centers of America, the largest group of Chiropractic clinics in the U.S.A., utilizing Non-Surgical Spinal Decompression. He has worked with two Presidents of the United States and two U.S. Surgeon Generals. He is CEO of Concierge Coaches, www.conciergecoaches.com, the #1 Chiropractic firm in Spinal Decompression and Neuropathy training nationwide. For more information on coaching or spinal decompression or seminars call 888-990-9660. www.thechiroevent.com
