A surge in epidural steroid injections to alleviate back and neck pain in the United States is bringing with it an increase in severe and unexpected complications, including paralysis and death, according to a report in Bloomberg News [here]. Nearly 9-million Americans received these interventional procedures during 2010 alone, and notices of serious adverse effects have prompted the U.S. Food and Drug Administration, in consultation with an advisory group, to review the safety of steroid injections into the epidural space near the spinal cord.
The FDA review comes during a boom in epidural steroid injections, which take minutes to administer and reap profitable reimbursements from Medicare and private insurers, the Bloomberg report observes. One study, by Laxmaiah Manchikanti, MD, chairman of the American Society of Interventional Pain Physicians (ASIPP), found the number of such injections among Medicare patients increased 159% between 2000 and 2010. Epidural injections are one of many interventional procedures — including implants of spinal cord stimulators — on which Americans spent $23 billion in 2011, up by 231% from 2002, the Bloomberg report notes.
The rise in epidural injections is being driven by two factors, the Bloomberg article claims:
- an aging population prone to back and neck pain, and
- generous reimbursements for interventional pain management procedures.
According to James Rathmell, MD — chief of pain medicine at Massachusetts General Hospital in Boston who alerted the FDA to cases of such injections causing harsh complications and is a member of the agency’s advisory group — “The problem with interventional pain is the majority of treatment is medical management. If you pay people to do stuff, they will do more stuff.”
David Armstrong, who authored the Bloomberg article, found that Medicare pays about $200 for a typical epidural steroid injection if given in a doctor’s office, roughly $400 if done at a surgery center, and about $600 if performed at a hospital. Some private insurers reimburse as much as 150% of Medicare rates. Meanwhile, the cost of the equipment, supplies, and staffing needed for a typical injection can be as low as $120.
The drugs used for epidural injection are anti-inflammatory corticosteroids, which are popular for easing pain in knees, hips, shoulders, and other parts of the body, in addition to the neck and back. The FDA review of epidural injections is being conducted by the agency’s “Safe Use Initiative, ” a unit formed in 2009 to reduce “preventable harm” from medications. The focus of their investigation will be on steroid injections via the transforaminal approach, which brings a needle within millimeters of critical arteries feeding the spinal cord (also see explanation below). About half of the 8.9 million epidural steroid injections in the U.S. last year were administered using that approach, according to Manchikanti.
Another area of concern noted in the Bloomberg report is the use of particulate steroids. This form of the drug is slow to dissolve and may create blockages that trigger strokes if accidentally injected into arteries. Labeling of these agents specifies that they are not indicated for epidural use and that serious adverse events, including death, may occur.