Douglas R. Bacon, M.D., Editor

Yes, Dear Thomas, There Is a Santa Claus

his has been a “big” fall for Thomas, the youngest of my four children. While his three older brothers are consumed with the challenges of high school, Tom quietly started the second grade in September. He started his first year of ice hockey in October, although he told his grandmother it wasn’t “real hockey” for another four years because there is no checking at his level. He celebrated his eighth birthday late in November. Tom has started asking questions about Santa Claus, about whether he is real, while listening to his friends who insist that the jolly old elf does not exist. He’s too young to understand Francis Pharcellus Church’s editorial, “Yes, Virginia, there is a Santa Claus”¹ from the 1897 New York Sun where he likens Santa to poetry, love, faith and the ability to believe in things unseen. My son is like the main character in the book Polar Express.² He wants to believe, yet he has doubts.

How, dear readers, does this relate to anesthesiology? Who is the specialty’s Santa Claus? Do we still believe we have or need such a figure? If so, how will we find Santa?

For years, industry played the role of Santa to the specialty, always ready to give financial support to any and all projects for which we desired funding — from sponsoring a continuing medical education (CME) seminar to seed money for a small clinical trial. When peer-reviewed funding from the National Institutes of Health (NIH) or other such grant-giving institute was not a realistic option, it was industry that was asked, and more often than not, it fulfilled the funding need. It seemed to be Christmas whenever we had a visit from our friends in industry. But in recent years, that willingness to support anesthesiology has gradually declined. Has Santa left the North Pole?

The answer to this perplexing question may have been presented at the recent Foundation for Anesthesia Education and Research (FAER) luncheon in Atlanta at our 2005 Annual Meeting. The subject was “Raising Money From Industry: Beyond Clinical Trials and Within Ethical Guidelines.” The program consisted of two talks, one by Mr. Bruce Gingles, a Vice-President at Cook Critical Care, and the other by Charles H. McLeskey, M.D., the Global Marketing Director for Anesthesia for Abbott Laboratories, with an audience discussion period following the presentations. The eye-opening part of the FAER luncheon for me was the staggering cost to bring a promising compound to market — before the first dose has been sold commercially. To recoup the cost of research and development, the drug needs to go to market quickly and generate $500 million to $1 billion in yearly sales. Thus there must be a significant demand for the agent before a company will spend millions of dollars and years preparing the “gift” for our specialty. Couple this expense with the fact that, unfortunately, anesthesiology is not a huge market when compared to internal medicine or surgery, and without a loud voice reiterating the “wish list,” there is little financial incentive to produce new anesthetic agents.

Another “stunning” comment by Dr. McLeskey emphasized the fact that, in his experience, anesthesiologists are not pushing industry to come up with better products, especially pharmaceuticals, to improve practice. When the representatives of industry ask what the specialty needs in terms of new agents or devices, the answer is often that we can make do with what we have. Rather than writing the traditional letter to Santa Claus requesting what we want or desire, anesthesiologists have been reluctant to demand better products. Why is this so? Has our specialty become so conservative that we no longer seek innovation but take comfort in the familiar? Have we lost our innate curiosity, the “driver” of innovation in practice and research?

The cynic in me responds that we as a specialty have been over-“hyped” about new products that are supposed to make anesthetic practice better. As a practicing anesthesiologist for the past 16 years, three pharmaceutical agents introduced in that time period have made a significant impact in the way I practice. The first drug, propofol, has had a daily influence, and another, sevoflurane, has made inhalational inductions in adults far more pleasant. The third agent, cisatracurium, is a second-generation drug that has a better side effect profile than its parent compound, but its use is really not that different. At work, I believe, is the natural skepticism of physicians to anything new — too often we have been told that the most recent “present” will cure every ill and work in every patient. After several years of experience, we know this simply cannot be true — patients are too different physiologically and pharmacologically.

If not anesthesiologists, who will generate our wish list? Who will write a letter to Santa, and where shall it be addressed? For I have come to believe that industry — the producers of agents and devices — is not Santa Claus after all, although it may be heavily involved in the North Pole workshop.

One of my colleagues, Christopher J. Jankowski, M.D., has discussed a tantalizing idea. Dr. Jankowski is interested in postoperative cognitive outcomes in geriatric patients and believes that to answer some of the major questions in that area, and in anesthesiology in general, large multicenter trials are necessary. These projects are, however, expensive and difficult to coordinate. To administer such an effort, a national group needs to be put together, perhaps funded by ASA. The group would ensure that the science and methodology of these studies were impeccable. For example, a first step would be to develop a consensus definition of relevant cognitive outcomes. Then multicenter trials could be developed to assess risks, outcomes and possible interventions for prevention and treatment. While these questions are critical to our geriatric patients, these same issues are relevant to our cardiac patients as well.

This national body would be able to help set the agenda for anesthesiology research for years to come without stifling individual initiative. Think about John F. Kennedy’s declaration that the United States would put a man on the moon before the decade of the 1960s was complete. It set the agenda in national space exploration research. Did it inhibit individual initiative? No, but it may have focused it. More importantly it electrified the nation and galvanized our resolve to reach this formidable goal. In the end, this national group would be no different than the NIH issuing a statement concerning the research it sees as the most important in the coming years. Yet it is anesthesiologists setting the agenda, not outside agencies and forces.

How would this group differ from FAER? Traditionally FAER’s mandate has been to support individuals in starting their research careers. The Foundation has done its work well, as many nationally prominent anesthesiology chairs began their academic/research careers with a grant from FAER, which supported their investigations until another source of funding, most commonly from NIH, could be secured. Over the last two to three years, FAER has established an Academy of Mentors to help guide young investigators on their career paths toward continual peer-reviewed funding. Grant approval, however, is based on the strength of the proposed science and the ability of the facility to support the investigator, not on any predetermined research agenda. Recently FAER was given a contingent sum of money by ASA to determine the feasibility of studies on awareness. This is the first small step toward setting a national research agenda in anesthesiology; however, House of Delegates action was in response to outside forces.

Somehow ASA must organize a collaborative research umbrella organization. In the language of our own House of Delegates, I RECOMMEND that ASA develop a committee of the president’s choosing to coordinate research in an attempt to decipher major questions of significance to the field that require large numbers of patients to answer. This alliance would have several important functions. In deciding the questions to be answered, this group will have influence beyond the halls of academia and the walls of our headquarters in Park Ridge, Illinois. It would send a clear message to our friends in industry about what we as physicians, as advocates for our patients, feel are the most important issues in anesthesiology research.

Second, it would allow for junior investigators to have a role and make contact with the research world without having to develop the basic infrastructure to submit a research protocol. Rather than having to start from scratch, they would gain experience reviewing protocols, working them through their institutional review board, collecting data and reporting it.

Third, it would begin to reverse the trend of research moving out of the United States and into Europe. In the recent European Society of Anaesthesiology Newsletter, Adrian Gelb, M.D., M.B., Ch.B., is quoted as saying, “Not only is it necessary to counterbalance American dominance, but the pendulum in the sciences, and in engineering, is moving toward Europe and Asia, and anaesthesia will follow along.”³

Finally, by participating in such an umbrella organization, junior investigators will make important contacts to help design future, and hopefully independent, work. Participants could help to stem the tide Dr. Gelb is talking about. The alliance could develop research talking points for anesthesiologists everywhere to bring to bear on their local commercial representatives, medical centers, universities and their appropriate governmental contacts. Also, it would be a further way in which ASA could support academic anesthesiology beyond a fight in the halls of Congress. It would once again put ASA on the cutting edge of what is possible within organized medicine, much like the founding of the Anesthesia Patient Safety Foundation and FAER in the mid-1980s.

Yes, there is a Santa Claus. Anesthesiology must look not to our colleagues in industry as Santa, but to a more mythical entity—research. It is from hard work in the laboratory, bedside, operating room table, intensive care unit or pain clinic that the difficult questions in anesthesiology will be answered. Yet research, like Santa, is hard to see — belief in its goodness is mandatory. Many of us will spend considerable sums this month supporting the standards of that jolly old elf who resides in the North Pole. Isn’t it appropriate that we anesthesiologists spend our capital in both time and money on research? It is the lasting gift we can give future generations of anesthesiologists, and more importantly, benefit every patient under our care. It is what distinguishes us from nonphysician anesthesia providers.

— D.R.B.

References:
1. From the Web site <www.educa.rcanaria.es/usr/zonzamas/virginia.htm>. Accessed on October 31, 2005.
2. Van Allsburg C. The Polar Express. Boston: Houghton Mifflin, 1985.
3. [Anon.] How big is too big? European Society of Anaesthesiology Newsletter. 2005; 24(Autumn):1

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