Circulation 76,548 • Volume 20, No. 4 • Winter 2005   Issue PDF

Reader Calls for Fair Risk-Benefit Analyses

Amir Tulchinsky, MD

To the Editor

I would like to comment on 2 articles in the fall APSF Newsletter, “Complications of Cervical Epidural Blocks Attract Insurance Company Attention” and “DepoDur™: A New Drug Formulation with Unique Safety Consideration.” I believe the articles have major problems and reflect poorly on how the APSF handles emerging safety issues.

The article on cervical epidural blocks is actually a nice mini-review; however, the entire focus of the article is on how to reduce insurance risk and it makes several recommendations. The article recommends the use of fluoroscopy, use of the prone position, avoiding injections if pain is experienced, and limiting sedation if possible. However, it is not clear in reading the case reports presented that any of these measures do any good! Fluoroscopy with epidurograms was used in the majority of cases, the use of sedation was about 50%, and the article pointed out, it is not clear that needle contact with the spinal cord is painful.

Thus, given that cervical spinal cord trauma may be reduced but not eliminated, the correct question is what is the risk versus benefit of cervical epidural injection? It is not a secret that there is a controversy and a paucity of randomized controlled data to show that epidural steroids are of benefit;1 some do not use them in their practice at all. If there are any benefits, they seems to be short lived and of limited clinical usefulness.2

The real story is not reducing the risks of cervical epidural steroids, but whether they should be done at all. If a drug were released by a pharmaceutical company that had an incidence of paralysis, arachnoiditis, anoxic brain injury, and death, and the company had difficulty showing that it had clinical utility, it would never be released. If the APSF had properly reviewed the literature, I believe a reasonable conclusion is to call for a moratorium on cervical epidural outside of randomized control studies, rather than to improve the informed consent process.

The second article, “DepoDur™: A New Drug Formulation with Unique Safety Considerations,” also missed the opportunity to improve patient safety. The headline on the second page of this article reads “Appropriate Protocols Needed for DepoDur™.” I was excited to read this article as the manufacturer has been widely advertising this medication, and drug representatives were making the rounds selling this drug.

This article, again well-researched and written, goes over the “benefit” of the drug avoiding the need for a “cumbersome epidural pump.” However, the article states that 4% of patients receiving this drug required naloxone. A recent review of epidural opioids put the established incidence of respiratory depression at 0.09% to 0.4% from continuous infusion of epidural opioids.3 I was expecting to get an appropriate protocol for use of this drug that has at least a 10-fold greater incidence of respiratory depression then current therapy. In fact, under the monitoring section of this article the only conclusion is that “there are no universally accepted stands or published guidelines for respiratory monitoring with opioid therapies by an accreditation body or society.”

Again the APSF has missed the big picture of putting patient safety first. A risk-benefit analysis again might call into question the need for this drug when its risk of respiratory depression is so much greater than current therapy, and its benefit is so trivial. Because of these questions, perhaps continuous pulse oximetry should be used until more data establish this drug’s safety. Perhaps, if the article were written by someone else other than an investigator involved in development of this drug, a more balanced view would be obtained.

The field of anesthesiology is routinely lauded for the great strides in improving patient safety and is held up as a model for other disciplines to follow. We need to continue being ever vigilant and to place our patients first, maximizing their safety and minimizing their risks. But we cannot rest on our laurels; we need to critically examine new medications and new procedures from an objective patient-oriented viewpoint. In the long run, this is what will keep our discipline strong and well respected.

Amir Tulchinsky, MD
Hartford, CT


  1. Butler, SH. Primum non nocere-first do no harm. Pain 2005;116:175-176.
  2. Koes BW, Scholten RJPM, Mens JMA, et al. Efficacy of epidural steroid injection for low-back pain and sciatica: a systemic review of randomized clinical trials. Pain 1995;279-288.
  3. Rathmell JP, Lair TR, Nauman B. The role of intrathecal drugs in the treatment of acute pain. Anesth Analg 2005;101:S30-43.