DISTRIBUTION A:
Approved for public release; distribution is unlimited.
Published: 1 December 2008
Air & Space Power Journal - Winter 2008
|
|
Ritalin seems to have become the drug for our day. As competition on every level intensifies, our preoccupations as a culture increasingly center on performance. And our children, whether we realize it or not, have been serving as a proving ground for the premise of medicating to enhance performance. Are we likely to see a time in the not-so-distant future when a large part of America will be running on Ritalin?
-Lawrence Diller, MD
Running on Ritalin
THE PRIMARY FUNCTION of the Air Force is to organize, train, and equip forces that a combatant commander will employ during the course of joint operations.1 The Air Force's health service and science and technology (S&T) communities, among others, support this function by providing expertise in human performance.2 In essence, then, the Air Force, in conjunction with other military services and civilian agencies, is responsible for providing human performance capabilities to the joint force. Ideally, we should optimize and enhance these capabilities so that we field (human) weapon systems superior to those of current and potential adversaries. Such thinking has driven heightened interest within the military services regarding human performance, in part sparked by the Office of Net Assessment's report entitled Human Performance Optimization and Military Missions.3 Thus, Department of Defense (DOD) Health Affairs formed a Human Performance Optimization Steering Committee,4 and US Joint Forces Command sponsored a human performance enhancement (HPE) joint-capability document (in draft) under the guise of joint-force health protection. For the purpose of this discussion, HPE encompasses those methods that enable Airmen to operate beyond established and sustainable performance thresholds. HPE brings to mind cutting-edge fields in biotechnology such as genomics and nanotechnology. However, we should conceptualize HPE as covering a spectrum ranging from intrahuman (e.g., biotechnology and pharmacology) to extrahuman (e.g., hardware and software), including such tools as selection, training, equipment, pharmacology, and surgery.
In the wake of this surge of interest in HPE, the Air Force medical community must be poised to consider performance-enhancement modalities within the context of Western society's principles of medical ethics: autonomy, nonmaleficence, beneficence, and justice. This concern is perhaps most pressing for pharmacological HPE since the military services employ this modality in current operations (e.g., fatigue countermeasures). Dating back to the fourth century BC, one of the most fundamental principles in medical ethics-first do no harm-received much attention during the first years of the twenty-first century, given the renewed public, judicial, and legislative interest in drug safety. For example, such popular and widely prescribed drugs as troglitazone, cerivastatin, rofecoxib, valdecoxib, and cisapride were withdrawn from the market. Manufacturers added boxed warnings to the labels for celecoxib and other nonselective, nonsteroidal, anti-inflammatory drugs, and to the labels for all antidepressants. There is continued concern over inaccurate perceptions that approval by the Food and Drug Administration (FDA) represents a guarantee of safety based on a high degree of clarity and certainty about a drug's risks and benefits. In reality, it is impossible to know everything about a drug at the point of approval because of the complexity of its mechanisms of action and because preapproval clinical testing generally occurs in controlled settings using carefully selected populations.5 At present a critical need exists for large, simple clinical trials to test the safety and real-world effectiveness of widely used drugs as well as those currently under development.6 In the meantime, in the absence of a public-health mandate, the ethical principle of autonomy dictates that physicians and patients cooperatively make individualized risk-benefit decisions regarding the selection and use of pharmaceutical agents for the prevention and treatment of human diseases.
Outside the clinical setting, how is risk-benefit defined in HPE? In the latter case, the individual is healthy, and the benefit is hypothetical (e.g., decreased likelihood that a drowsy Airman will commit an error of omission or commission with significant effect on the mission). The benefit is hard to define quantitatively, as is the risk. Often the drug is used for a non-FDA-approved indication, and the intended population does not represent the one employed in preapproval testing or observed during postapproval surveillance. Although clinical testing reliably detects adverse events occurring in one of 100 patients, it probably will not observe such reactions occurring in one of 1,000 patients-or less frequently, even if they are very severe.7 Thus, many HPE studies of pharmacologic agents are unlikely to involve sufficient numbers of participants (i.e., statistical power) to adequately assess the risk of adverse events. For example, the authors' cursory review of the literature found no HPE studies of modafinil as a fatigue countermeasure that even came close to utilizing 100 participants. Though not surprising, given the difficulties of conducting large trials, such a situation does raise ethical concern over meaningful, informed consent (i.e., the ethical principle of autonomy) since both risks and benefits remain largely undefined. In addition, can military leaders reliably depend on pharmaceutical countermeasures when they plan operations and at the same time respect the ethical principle of autonomy? Although use of the current generation of HPE agents is limited to select populations and situations, could more widespread usage in the future create an inherently coercive environment and compromise individual autonomy if performance is a factor in the selection and promotion of Airmen? Given these considerations, initially well intended HPE requirements such as a nonaddictive pill to maintain vigilance in the face of routine, prolonged wakefulness; a prohormone to increase muscular strength and endurance during training; or pharmacotherapy to enhance cognitive function and decision making may have ethically unacceptable ramifications from a medical and societal perspective.
Many of the ethical issues raised with pharmaceutical HPE also apply to nanotechnology, a burgeoning field featuring particles smaller than one micron. Nanotechnology may be poised to transform medicine with potential uses spanning all aspects of disease diagnosis, prevention, and treatment as well as HPE applications such as embedded intelligence.8 However, at present we lack comprehensive and conclusive information on the long-term health and safety effects of nanomaterials.9 For example, preliminary evidence suggests that the large surface area of insoluble nanoparticles can trigger inflammatory responses, and a substantial body of evidence supports the conclusion that chronic inflammation can predispose an individual to cancer.10 Although we need more research into the health effects of nanotechnology before we can consider human use, such concerns highlight the larger issue of prolonged and potentially lifelong surveillance when using HPE agents. Since cancers usually have latencies of 15-20 years or more, ideally we should require an assessment program akin to the Longitudinal Study of Astronaut Health for Airmen exposed to HPE agents in order to adequately address the ethical principles of autonomy, nonmaleficence, and beneficence.11 Current fiscal realities make such a program impracticable and unlikely to be implemented. However, we could begin other forms of surveillance, such as conducting periodic health surveys or tracking medical-claims data for Airmen receiving government-funded medical benefits, at significantly less expense. Ultimately, we will discover adverse effects associated with long latencies only by tracking the health of Airmen long after they have separated from military service. The potential need for such surveillance is a hidden cost that should be factored into decisions to use HPE agents.
Like nanotechnology, advances in genetic S&T have enormous potential to revolutionize medicine in terms of assessing risk for and treating human diseases. However, the same technology that enables gene-transfer therapy for treatment of clinical disease can also be used for HPE. Already the term gene doping has entered the sports lexicon.12 For example, it may be possible to transfer genes that release human-growth hormone to build muscles or that enable muscles to use oxygen more efficiently for endurance. On the horizon, gene transfers may target the calcium channels in muscles to make them more responsive, strengthen bones, and blunt or eliminate the response to pain. At the extreme, genetic engineering-to date limited to plants and animals-could be used to create an optimized "warrior" germ line sometime in the not-too-distant future. For a long time, bioethicists working in the field of genetics have voiced concerns about the ethics of genetic enhancements, especially those inherited as a result of germ-line, gene-transfer technologies. They have raised questions about the long-term safety of such interventions, the viability of consent when cross-generational effects are prevalent, and the possible impact of enhancements on our conceptions of human achievement and excellence.13 Although the creation of a warrior class may sound implausible in contemporary Western society, what about other societies-whether allied, neutral, or adversary? What about the apparently less sinister gene doping?
This discussion has only scratched the surface of potential ethical issues brought on by advances in HPE. Up to this point, the dialogue has focused solely on biotechnology. However, ethical dilemmas likely will exist across the HPE spectrum. For example, are there ethical implications in conducting psychological screening and training to develop and harden aggressive personality traits in Airmen? What are the ramifications for those Airmen's families during their military service and for society at large upon their separation or retirement? Even a seemingly innocuous HPE intervention such as nutritional supplementation now has attendant ethical considerations, given evidence from recent intervention studies of previously unrecognized risks caused by nutrient toxicity and nutrient interactions.14 Overall, we should not view HPE as inherently unethical since it may in fact be ethical in terms of beneficence (i.e., increased likelihood of survival). Given the military services' heightened interest in human performance and the ongoing efforts to develop HPE road maps and requirements, we should address ethics early in the process. Unfortunately, existing policy, concepts of operations, and doctrine do not address HPE, let alone the associated ethical issues.15 Thus, we urgently need to confront this situation in light of the rapid pace at which new S&T advances with potential HPE applications appear. That said, we offer four recommendations. First, the Air Force should include human performance in its existing and future doctrine-the officially accepted practices taught to Airmen, related to means and involving issues of how strategy is carried out.16 Thus, doctrinally addressing human performance compels the Air Force to officially contemplate and codify the means by which it will use human weapons to achieve military strategy. The LeMay Center for Doctrine Development and Education Center at Maxwell AFB, Alabama, is the logical agency for coordinating this work. However, given the unprecedented nature of this subject matter within the doctrinal community, we require a deliberative process that actively involves and informs all relevant stakeholders, including the war-fighter, S&T, medical, legal, and bioethical communities. Equally important, this work must proceed quickly so the Air Force can proactively manage rather than react to HPE.
Second, the Air Force surgeon general should develop a code of practice that balances accepted medical ethics with the military's unique need for superior (human) weapons. Ideally, this task would occur concurrently with the development of an official Air Force human-performance doctrine. Air Force medical personnel are at the front lines of this issue, advising commanders on HPE and prescribing pharmaceutical HPE agents. However, as we have discussed, HPE doesn't fit well within ethical frameworks developed for treating disease. In the absence of clear professional or societal guidance, we think that this ethical uncertainty should be addressed at the organizational level rather than leaving it to individual medical personnel for resolution. The Air Force Medical Service should establish a panel composed of medical leadership and bioethicists at the Air Force and major-command levels, as well as representatives from the state medical boards (which license DOD medical personnel), to draft a code of practice for endorsement by the Air Force chief of staff. Doing so will lead to a consistent and defensible use of HPE agents across the Air Force.
Third, the Air Force should establish an extended longitudinal-surveillance program for Airmen exposed to current and future HPE agents. The Air Force surgeon general should have primary responsibility for administration and oversight of this program, which would serve the two separate goals of surveillance of occupational health effects from HPE agents and research into their long-term effects. However, a credible, independent agency such as the Institute of Medicine should be commissioned to develop the protocol for conducting this surveillance and periodically assessing the data collected. Information on exposures to HPE agents must be collected and correlated with individual Airmen, as is presently done for other occupational exposures such as toxic industrial materials, noise, and so forth. The Air Force should then assume responsibility for the lifelong surveillance of those Airmen exposed to HPE agents, including the conduct of periodic surveillance exams and compensation for associated costs incurred.
Finally, the assistant secretary of defense for health affairs should conduct a workshop to define minimum evidentiary standards (e.g., sample size, duration of assessment, measures of merit, etc.) for preapproval and postapproval studies assessing the effectiveness and safety of HPE agents. This workshop should include experts from academia and nongovernmental organizations (e.g., the Institute of Medicine), government research agencies (e.g., the National Institutes of Health), and appropriate regulatory agencies such as the FDA. Its recommendations should form the basis for subsequent DOD policy.
Brooks City-Base, Texas
Monterey, California
Notes*Colonel Brown is director, Human Performance Integration, 711th Human Performance Wing, Brooks City-Base, Texas. Lieutenant Colonel Tvaryanas is a PhD candidate at the Naval Postgraduate School, Monterey, California
[Feedback? Email the Editor ]
1. Air Force Doctrine Document 1, Air Force Basic Doctrine, 17 November 2003, 35, https://www.hqafdc.maxwell.af.mil/afdcprivateweb/ AFDD_Page_HTML/Doctrine_Docs/afdd1.pdf.
2. Agile Combat Support Concept of Operations (Washington, DC: Air Staff Directorate of Logistics Readiness, 15 July 2005), H-1, T-1.
3. Adam Russell, Bartlett Bulkley, and Christine Grafton, Human Performance Optimization and Military Missions, report for the director, Office of Net Assessment, GS-10F-O297K (McLean, VA: Science Applications International Corporation, May 2005), 10-12, 92-101.
4. Patricia Deuster et al., Human Performance Optimization in DOD: Charting a Course for the Future, report prepared by the Human Performance Optimization Steering Committee for the assistant secretary of defense for health affairs (Bethesda, MD: Department of Military and Emergency Medicine, Uniformed Services University, 28 June 2006), 3.
5. Alina Baciu, Kathleen Stratton, and Sheila Burke, eds., The Future of Drug Safety: Promoting and Protecting the Health of the Public (Washington, DC: National Academies Press, 2007), 17-20.
6. Judith S. Hochman and Nirav R. Shah, "What Price Pain Relief?" Circulation 113, no. 25 (27 June 2006): 2868-70, http://circ.ahajournals.org/cgi/reprint/113/ 25/2868.
7. Brian L. Strom, "How the US Drug Safety System Should Be Changed," Journal of the American Medical Association 295, no. 17 (3 May 2006): 2072-75, http://jama.ama-assn.org/cgi/reprint/295/17/2072.
8. Tracy Hampton, "Researchers Size Up Nanotechnology Risks," Journal of the American Medical Association 294, no. 15 (19 October 2005): 1881-83, http://jama.ama-assn.org/cgi/reprint/294/15/1881.
9. Paul A. Schulte and Fabio Salamanca-Buentello, "Ethical and Scientific Issues of Nanotechnology in the Workplace," Environmental Health Perspectives 115, no. 1 (January 2007): 5-12, http://www.ehponline.org/members/ 2006/9456/9456.pdf.
10. Claire Monteiller et al., "The Pro-Inflammatory Effects of Low-Toxicity Low-Solubility Particles, Nanoparticles and Fine Particles, on Epithelial Cells in Vitro: The Role of Surface Area," Occupational and Environmental Medicine 64, no. 9 (September 2007): 609-15; and Emily Shacter and Sigmund Weitzman, "Chronic Inflammation and Cancer," Oncology 16, no. 2 (February 2002): 217-29.
11. David E. Longnecker, Frederick J. Manning, and Melvin H. Worth Jr., eds., Review of NASA's Longitudinal Study of Astronaut Health (Washington, DC: National Academic Press, 2004), 9-15, 45-52.
12. H. Lee Sweeney, "Gene Doping," Scientific American 291, no. 1 (July 2004): 62-69.
13. Ronald Green, guest editor, "Justice and Genetic Enhancement" (special issue), Kennedy Institute of Ethics Journal 15, no. 1 (March 2005): 1-2.
14. Alice H. Lichtenstein and Robert M. Russell, "Essential Nutrients: Food or Supplements? Where Should the Emphasis Be?" Journal of the American Medical Association 294, no. 3 (20 July 2005): 351-58, http://jama.ama-assn.org/cgi/reprint/294/3/351.
15. Deuster et al., Human Performance Optimization, 6-7.
16. Maj Gen I. B. Holley Jr., USAF, retired, Technology and Military Doctrine: Essays on a Challenging Relationship (Maxwell AFB, AL: Air University Press, 2004), 1-3, http://www.maxwell.af.mil/au/aul/aupress/books/Holley/Holley.pdf.
Disclaimer
The conclusions and opinions expressed in this document are those of the author cultivated in the freedom of expression, academic environment of Air University. They do not reflect the official position of the U.S. Government, Department of Defense, the United States Air Force or the Air University
[ Home Page | Feedback? Email the Editor ]
