New debate about the safety of anesthetic medications that have been used literally millions and millions of times over several decades seems as if it would be, by definition, healthy and valuable. However, the tone and result seem to be different now in the mid -1990’s. Analogous changes in the medical device field seem also to be taking place. Issues (often involving a very small number of cases of questions or supposed adverse effects) that in previous times would have been discussed in the literature and evaluated by anesthesiology scholars now appear to virtually instantly provoke broad, sweeping indictments and immediate actual or threatened regulatory intervention to limit or forbid the use of the medication or device.
It is worthwhile to examine the admittedly difficult balance between years or decades of effective, apparently safe use of something and the understandable desire to make things now as safe as humanly possible for our patients.
Is Sux Safe? Myopathy Very Rare
As reflected in the debate that is the lead article of this issue of the Newsletter, succinylcholine has been administered to children and adolescents many millions of times. As with all medications, there are both predictable and unpredictable rare (actually extremely rare) adverse responses. Proponents of the very strong FDA-approved labeling change (which, as correctly noted by letter writers to Anesthesiology, has significant medical legal implications for plaintiffs’ lawyers) making succinylcholine ‘contraindicated’ for children and adolescents cite as their main point that it is impossible to know which child or teen has an undiagnosed myopathy that may predispose to dangerous hyperkalemia after succinylcholine. Therefore, they argue, no child or teen should receive succinylcholine unless there is one of the small number of specific positive indications.
Opponents of this functional ban on succinylcholine correctly state that this change breaks new ground for establishing contraindications and, if this is the way it is going to be, there are a host of other medications that should be limited or banned, including sodium thiopental for fear of undiagnosed porphyria and intravenous antibiotics for fear of anaphylaxis. While extreme to make a point, these proposals highlight the issue are we getting too afraid? Proponents of the ban say there are fully equivalent alternative medications. Opponents of the contraindication state forcefully that this simply is not true and also seem possibly to question the motives of the manufacturers involved.
Spinal Lidocaine Too?
There is another, apparently similar, controversy brewing. In what appears to be a reasoned, thoughtful analysis, the safety of hyperbaric lidocaine in dextrose
for routine spinal anesthesia was questioned in an editorial in January’s Anesthesia and Analgesia.’ This medication also has been used effectively and safely many millions of times. Now a report of four cases of transient radiculopathy out of 88 patients prompts a review of what is known and results in the suggestion that lidocaine may, in fact, be neurotoxic in this setting. Microcatheters for continuous spinal infusion have already been banned, in retrospect possibly because they delivered this toxic drug to a small area of effect. Because of the obvious climate of rapid trial, conviction, and execution in this arena, can any modern anesthesiologist doubt that there is active consideration right now of a new contraindication and an effective ban of hyperbaric lidocaine for routine spinal anesthetics? Is this reasonable or are we becoming too afraid? How can we tell? What is happening here?
One important thing that is happening here is tied directly to the evolution of the anesthesia patient safety movement over the last decade or so. Because anesthesia is so much safer and the major accidents causing cardiac arrest, brain damage, and death have been so significantly decreased, new emphasis and attention have been focused on issues that previously may have been overshadowed by the then-unquestioned large issues in anesthesia safety. Possibly, problems that before were simply not recognized may now stand out more in the spectrum of anesthesia complications and, as a result, receive attention for the first time. A second possibility is that new sophistication and methods of investigation exist which allow detection of previously unrecognizable problems. A third consideration is that the described phenomena are actually new problems that could not have been seen before as they did not exist. At first pass, this seems unlikely. Finally, perhaps these really are not problems at all and over enthusiasm at the potential of finding problems helps create an impression of trouble where no problem exists.
The interaction of fears on the part of some (possibly only a few?) anesthesiologists with the governmental and regulatory environment is critical in this discussion. In the succinylcholine debate, the U.S. Food and Drug Administration (FDA) played a significant role in the decision to create the contraindication. Has there been a shift on the part of government in general and the FDA in particular from the traditional mission of ‘facilitate and educate’ to a new emphasis on the concepts of ‘regulate and punish”? This particularly is where the connection to medical devices is made. Mr. James S. Benson, Senior Vice President of the Health Industries Manufacturers Association, spoke in February to a medical design and manufacturing meeting and specifically commented that it appears that the FDA is promoting a strong “get tough’ image. He noted that the public confidence in both the medical manufacturing community and the FDA are very low due to things such as the highly publicized questioned safety of some types of artificial heart valves, silicone breast implants, various generic drugs, and many other things. There is concomitant parallel pressure coming from the U.S. Congress. In response, the FDA seems to be significantly tightening control, regulation, and enforcement. Very importantly in this discussion, it is very likely that this atmosphere promoting ‘get tough’ regulation by government makes it much more probable that the response to any perceived safety issue will take the form of regulation and limitation. In even the recent past, regulators likely would have allowed more time for the issue to develop on both sides in the scientific literature and discussions (such as panels and symposia at national meetings). In the new ‘tighter’ climate, it seems this is not going to be possible and new regulations come down comparatively very quickly.
Are we (and the regulators who now have such a great role in our professional lives) becoming too afraid? There is no easy simple answer. Striving toward the goal of absolute minimum risk is, of course, good. However, it is possible to throw out the baby with the bath water and quickly condemn or even eliminate medications, devices, or strategies that have been time-tested and considered safe for a very long time. Therefore, as is usually the case, the current path should be somewhere between the two extremes. Yes, there should be some fear and some regulation. No, these should not be unreasonable, onerous, and unnecessarily restrictive. It seems as if there needs to be careful thought and evaluation leading to the implementation of common sense actions. There should be the intense, thorough involvement of the practitioners directly affected by the issues. Unilateral action rarely is appropriate. National groups and societies can organize open invitation meetings focused on specific issues and the proceedings can be published as journal supplements for all practitioners to evaluate. Then their input into the consensus process can be based on the most recent, complete data and analysis.
Before the label change contraindicating succinylcholine in children and adolescents, there should have been the equivalent of a ‘consensus conference’ involving practitioners, representatives of involved professional societies, researchers, manufacturers, and regulators. However difficult and however long it took, this group should have kept at it until there was some type of agreement as to the most reasonable course. Yes, this is expensive and difficult to organize. However, the stakes are high and this type of activity is precisely what we as a profession should be intensely involved with. Device questions can be handled the same way. There should be an immediate reevaluation through this type of mechanism of the succinylcholine decision. Hyperbaric lidocaine spinals should also be approached in this manner. So, too, should future questions of a similar nature. Only then will we be able to practice without unnecessarily heavy-handed regulation and also without wondering if we are becoming too afraid.
John H. Eichhorn, M.D. Editor, APSF Newsletter
- deJong RH. Last round for a ‘heavyweight’? Anesth Analg 1994;78:34