Too Limited a View of What Clinical Anesthesiology Could Become
Dr. Hartung makes several interesting points, although I find I cannot agree with them. His observation that “several laboratories in departments of anesthesiology are looking for new classes of biopharmaceuticals…” is probably an underestimate. Numerous departments, my own included, are involved in “gene-related” research that might someday have relevance to human pathobiology, but that is a far cry from these techniques becoming routine in the practice of medicine in general or anesthesiology in particular.
In some ways, our differences of opinion on this point may reflect differences in our view of what constitutes the practice of anesthesia. Because Dr. Hartung is not a physician this is understandable. But, it is an unfortunate fact that anesthesiologists, particularly those in the United States, have largely (though not uniformly) withdrawn form anything but very short-term involvement with patients. This fact is sadly documented in a recent article in this journal that underscored the marked decrease in the number of anesthesiologists practicing critical care medicine. 1Because gene-based therapies require longer-term (i.e. , days to weeks or even life-long) involvement with patients it is unlikely that anesthesiologists will be routinely involved unless the unfortunate pattern of anesthesiologists withdrawing exclusively into the operating room environment reverses itself. This is not to say that we will not administer gene-directed drugs to our patients while they are in the operating room, but this is likely to be no more a part of the practice of anesthesia than is our administering an antibiotic before every surgical procedure.
I also think Dr. Hartung's suggestion that the availability of pharmaceuticals for our use need not be dependent on pharmaceutical companies, and the financial aspects of drug development is a bit naïve (admittedly my view may be a bit jaded). The Orphan Drug Act exists because pharmaceutical companies would not produce some drugs that people need if they could not make money doing so. More directly relevant to anesthesiology is the fact that we have known since the 1970s that xenon may be superior to any other “volatile” anesthetic currently in use; but we do not have it for our patients because no pharmaceutical company can figure out how to patent an element and make money selling it. Too, fentanyl and sufentanil have never been approved by the Food and Drug Administration for intrathecal use, despite the overwhelming evidence that their use benefits patients, because no drug company sees a financial value in doing the necessary work to get them approved.
Deep-throat's admonition to Woodward to “follow the money” is as true when trying to figure out what pharmaceutical companies may choose to develop as it was in trying to understand what was going on in Richard Nixon's Whitehouse. Like it or not, the financial aspects of pharmaceutical development will determine what gene-directed products are available for our use. Dr. Hartung is correct that we can participate in the process by identifying problems that might benefit from gene-directed pharmaceuticals, but doing so will not guarantee that such products will come to fruition.
Finally, I do not mean to suggest that my view of how this issue may evolve in the future is the preferred path. Rather, I sincerely hope Dr. Hartung's view prevails. But I would be disingenuous if I said I thought he was correct.