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Go pills in combat: prejudice, propriety, and practicality.

Editorial Abstract: The military's use of medications for operational reasons has traditionally garnered substantial, often negative, attention from the popular nexus media--and sometimes from the scientific community as well. However, the author details how clear guidelines on the use of stimulants (and, by inference, other counterfatigue medications) in operational contexts optimize the safety, performance, and general well-being of US military combat-aviation personnel while preserving their rights to make informed decisions about their own lives.

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THE MILITARY'S USE of medications for operational reasons has traditionally garnered substantial attention from the popular news media and sometimes from the scientific community as well. Unfortunately, this attention often is decidedly negative. For instance, although we now accept the appropriateness of vaccinating US forces against germ warfare, in 1998 Secretary of Defense William Cohen's mandate that all personnel receive anthrax vaccinations prompted numerous congressional hearings and legal disputes. Meanwhile the media reported that significant numbers of personnel were "leaving the armed forces because they did not want to be vaccinated." (1) The use of the nerve-agent pretreatment pyridostigmine created a similar controversy following the Persian Gulf conflict of 1991 because of the medication's wide use for what is generally referred to as an "off-label" indication. (2) Although a later ruling permitted its appropriate administration following either presidential orders or individual informed consent, questions continued with regard to the safety and wisdom of policies concerning this prophylactic intervention. (3) More recently, the military's use of dextroamphetamine to sustain the performance of sleep-deprived pilots created concern after two pilots blamed a friendly-fire incident in 2002 on their use of this medication. (4) Despite the fact that an Air Force investigation ultimately failed to implicate dextroamphetamine as a contributor to this unfortunate event, the general public knew nothing of this fact; thus, many people continue to question the military's use of dextroamphetamine and other performance-sustaining pharmacological compounds.

Incidents such as these contribute to ongoing debates about the ethics of using medications to protect or sustain (or augment) our military personnel. These debates are particularly pointed with regard to the military's use of counterfatigue medications--especially stimulants such as amphetamines. In fact, the issue of the appropriateness of using counterfatigue drugs to augment combat safety and performance has again become a topic of considerable discussion. (5) Some North Atlantic Treaty Organization members consider the US military's use of prescription stimulants such as amphetamines unethical, and this stance on the ethical ramifications of "performance-enhancing drugs" may be largely responsible for the fact that the United States currently is the only major world power authorizing the operational use of amphetamines and some other counterfatigue medications. (6)

As a research scientist who has conducted numerous studies on the operational utility of prescription stimulants in US aircrews, I find it difficult to understand why some people raise the question of ethics regarding the uses of these compounds. (7) The military's use of "cognitive performance enhancers" is ethical as long as (1) the decision to use a performance-enhancing /sustaining medication rests freely with the individual; (2) the use of the drug is safe within the context in which it is used; (3) the manner of the substance's use remains consistent with its dosage and pharmacological function; and (4) in general, the military employs medication options only after exhausting nonpharmacological alternatives. (8)

On these grounds, one might ask why anyone would consider physicians wrong to prescribe amphetamines (or other stimulants) to perfectly healthy, nonmilitary people so that they can get by with less sleep for the sake of working (or playing) longer hours. A close examination shows that such a prescription would meet the first criterion and possibly the third, listed above, but prescribing stimulants to healthy civilian workers violates the second and fourth criteria. Failure to meet the second criterion stems from the fact that, unlike military-aviation personnel closely monitored by medical personnel, civilians walk out of the physician's office (or the pharmacy) with a multiday supply of the drug, able to use it in the absence of close medical supervision. This is potentially unsafe, especially considering amphetamine's potential for abuse and, in this case, the fact that patients are free to modify the prescribed dosage in any number of ways (some of them possibly dangerous). Failure to meet the fourth criterion stems from the physician's not having exhausted the nonpharmacological alternatives. Unlike military pilots who use the stimulant medication to perform a potentially life-saving mission that they probably could not do effectively without the aid of the drug, civilian patients (who in this example do not suffer from some type of alertness disorder) really have the choice of remaining awake for a shorter period and choosing to sleep sufficiently rather than electing to take a drug in order to prolong wakefulness. Little downside accompanies this choice (to sleep) because although civilian patients won't be able to work or play longer than normal without the stimulant, they are unlikely to suffer harm as a result. Thus, offering stimulants to healthy civilians for everyday use clearly presents a less favorable risk/benefit ratio and a less favorable ethical stance than prescribing them for military pilots, who have little choice except to engage in sustained combat operations.

Do "morality" issues attach to the military's use of "cognitive-enhancing agents"? That is a difficult question to answer since different people define morality in various ways. For some, ethical actions are also moral; for others, morality refers to the concept of absolute "rightness" or "wrongness"; and still others define morality contextually. (That is, if the ultimate outcome is "good," with no intent to harm another innocent human being, violate an innocent person's rights, or cheat people of their rightful possessions, then the actions are moral.) (9) The US military's use of performance-enhancing medications seems "moral" because it utilizes them to meet specific objectives upon which we as a nation presumably agree--and to do so in a way that improves the survivability of our personnel under less-than-optimal circumstances. We do not force our personnel to ingest stimulant medications against their will; neither do we force our enemies to ingest them. Rather, we offer the medications, which have been proven "safe," in order to protect the well-being of our military personnel. (10) For all practical purposes, we as a nation have essentially agreed that this type of medical intervention is acceptable to achieve desired tactical outcomes (extant policies authorize such use). Yes, these medications may contribute to our ability to harm our enemies, but we already use a variety of other strategies (technological, behavioral, etc.) for this purpose. The fact that cognitive enhancers provide a tactical advantage over our enemies is not considered cheating any more than the fact that our use of superior night-vision technology offers a tactical advantage. Also, I should note that in strict terms of fairness, we publish information on our use of or intent to use pharmaceutical performance enhancers in the open scientific literature, which our enemies are free to read and take advantage of. Thus, in my opinion, our use of these medications is both moral and ethical.

However, since the use of pharmacological compounds is a medical and/or behavioral-sciences issue and since published standards outline the principles of ethical actions in both of these fields, let us rely on these standards to address the appropriateness of using the medications that are the subject of this article. I first present a brief overview of the basic ethical principles that guide the behavior of physicians and psychologists. Then I discuss as a primary example the military's use of dextroamphetamine as a safe and effective fatigue countermeasure for combat-aviation operations, explaining why our current stance on the use of this medication--and, by inference, other counterfatigue (or performance-enhancing) drugs--does not pose an ethical dilemma for the US military.

Basic Ethical Principles

General ethical principles are designed to inspire individuals to act in accord with the highest standards and ideals of their respective professions. Caring for others, inspiring trust, behaving honestly, treating people fairly, and respecting the essential worth of human life are core characteristics of ethical thoughts and actions. Ethical professionals strive to benefit those with whom they work and to minimize the possibility of doing harm. They are trustworthy and mindful of their responsibilities to others. They are truthful, accurate, and honest. These individuals take care to justly distribute their contributions among those for whom they are responsible. And they respect the rights of every individual to privacy, general well-being, and self-determination. In summary, ethical professionals make every effort to treat others with the same fairness, dignity, and respect they would hope to receive themselves. (11) Given the basic tenets of ethical behavior outlined above, let us examine the military's use of dextroamphetamine as an example and determine whether guidance governing the use of this compound is ethically appropriate.

History of the Dextroamphetamine Policy

Fatigue from sleep loss and body-clock disruptions is a widespread problem in military operations, particularly in recent high-tempo actions associated with the global war on terror. (12) Such around-the-clock operations, rapid time-zone transitions, and uncomfortable sleep environments are common on the battlefield; unfortunately, these conditions prevent personnel from obtaining the eight solid hours of sleep required for optimum day-to-day functioning. Sleep in the operational environment often is fragmented for weeks at a time and sometimes totally nonexistent for days at a stretch. (13) Needless to say, such sleep deprivation rapidly degrades reaction time, alertness, attention, and mood, leading to seriously impaired safety and performance. (14) Generally speaking, every 24 hours of sleep deprivation produces a 25 percent reduction in operational performance, with higher-level cognition the most severely compromised of all capabilities. (15) Thus, unsurprisingly, we have determined that fatigue exacts significant social, financial, and human costs and that it has been implicated as a causative or contributing factor in numerous military-aviation mishaps. (16)

In an effort to counter fatigue-induced performance decrements, the military has invested substantially in what is often termed alertness-management research. This research resulted in an array of strategies, including duty-time limitations, behavioral countermeasures, napping interventions, and drug-based remedies designed either to enhance available sleep opportunities or to sustain performance despite sleep deprivation. The strategy of periodically using dextroamphetamine was one product of this research thrust, and I will use the procedures governing dextroamphetamine therapy as the primary example in this article.

Amphetamines became available for prescription in 1937, and by the time of World War II, the German, Japanese, and British militaries used them to enhance performance on the battlefield. Although some reports indicate that US forces used the drug during the Korean conflict, the US Air Force did not officially sanction the use of dextroamphetamine for performance sustainment until 1960. (17) Subsequently, widespread use of amphetamines by military aircrews probably first occurred during the Vietnam conflict. The policies concerning stimulants evolved into Air Force Regulation 161-33 / Tactical Air Command Supplement 1, The Aerospace Medicine Program, 1 January 1984, which sanctioned the use of amphetamines by single-seat pilots in particular due to their susceptibility to boredom and fatigue during deployments and extended combat air patrols. In 1996 Air Force leadership rescinded the long-standing approval to use amphetamines in aviation operations.

The Air Force suspended amphetamine authorization even though the use of dextroamphetamine evidently played no part in mishaps during Operation Desert Storm. (Fatigue contributed to a number of them, however.) Furthermore, one survey collected during Desert Storm noted the value of amphetamines for maintaining alertness in flight operations, and one squadron commander described the availability of the medication as a "safety of flight" issue. (18) These results, coupled with data from four placebo-controlled aviation studies conducted between 1995 and 2000 led, in part, to the reintroduction of approval to utilize dextroamphetamine in select combat Air Force operations in 2001. (19)

The Real Issues at the Heart of the Current Stimulant Policy

All three US military services currently approve dextroamphetamine for the sustainment of combat-pilot performance under particularly fatiguing circumstances. When considering the ethical implications of using this prescription medication for maintaining the alertness of sleep-deprived but otherwise normal personnel, one must first consider a couple of points.

First, detractors of the current stimulant policy often describe the choice of whether or not to use stimulants as one between having well-rested pilots fly their missions drug free versus having sleep-deprived pilots fly their missions on drugs. However, as I have already noted, military operations often inevitably entail unavoidably high levels of fatigue. Thus, in actuality, the real choice lies between having sleep-deprived pilots fly the mission with the aid of proven, alertness-enhancing drugs versus having them fly the mission while struggling to stay awake on their own. Further, research has shown quite clearly that attempting to self-sustain wakefulness in the presence of substantial sleep pressure (fatigue) is a losing proposition.

Second, detractors often like to draw comparisons between civil-aviation operations, which do not allow stimulants, to military-aviation operations, which do permit them. They ask why the military allows these drugs when the civilian world does not. In answering this question, one should clearly understand that the two situations are not comparable.

One major difference is that combat-aviation missions are presumably significantly more stressful than commercial air-transportation operations. For instance, although airline-transport pilots no doubt experience stress from their responsibility for the safety of up to 400 passengers, they are rarely targets of enemy aggression. Combat pilots, however, routinely perform their duties under imminent and palpable threats to their own safety and, in fact, their very lives. Additionally, military aircrews routinely find themselves subjected to the most arduous and continuous flight schedules--sometimes requiring numerous, successive missions despite the absence of adequate crew rest--in order to sustain the operational tempo, whereas stringent crew-rest and duty requirements specified in Federal Aviation Administration regulations protect commercial crews from such circumstances.

Another major difference is that the consequences of cancelling a commercial flight differ markedly from those associated with calling off a military flight. If a fatigued airline pilot declines a flight due to concerns over his or her impaired performance capabilities, the airline may not like the decision, but, clearly, it jeopardizes no one's safety. Instead, the airline will replace the fatigued pilot with a rested standby pilot, who will complete the scheduled flight. Every major commercial air carrier has clear contingencies for such events. However, in a military context, already severely limited by the number of available pilots, an aviator's decision to decline a mission will probably result in delaying or simply not flying it. Like the airline passengers mentioned previously, those scheduled to fly aboard the affected aircraft likely will be safer, but what about the soldiers awaiting medical evacuation from the field? What about the units awaiting resupply of ammunition, food, and water? And what about the people threatened by enemy fire? What about their safety after cancellation or delay of a scheduled military mission?

When considering the military's position on stimulant use, one must remember (1) that combat is not a sporting event but an unpredictable, life-threatening, stressful, and faxiguing endeavor calling for the employment of every reasonable aid to success, and (2) that in order to protect and defend the lives of our friends and allies, US military pilots must think far beyond the most immediate ramifications of their decisions regarding mission acceptance and completion. It is within this context that we must consider the ethics of stimulant use (as well as the use of other performance-enhancing medications).

Current Guidelines for Amphetamine Use in Air Operations

Much careful forethought went into the US military's current dextroamphetamine policy, with the aim of protecting individual war fighters--primarily aviators-and of fulfilling our military objectives. (20) Moreover, as I will show (primarily by citing Air Force policies/procedures as an example), guidance ensures that we can achieve these aims without compromising professional ethical principles. The following tenets assure the appropriate use of dextroamphetamine: (21)

1. Clear guidelines dictate the circumstances under which one can utilize dextroamphetamine in operational contexts; they also extend its use to exceptional circumstances. These guidelines specify mission durations and drug dosages.

2. Prior to using dextroamphetamine, each pilot must read and sign a detailed informed-consent agreement to ensure sufficient knowledge about both the positive and potentially negative effects of the medication. Failure to obtain documented informed consent precludes the operational use of the drug for that individual.

3. The population authorized to utilize sfimulant medication (military aviators) is by nature young, healthy, and likely free of any medical complications that would contraindicate the use of dextroamphetamine. Military pilots must routinely undergo recurrent physical examinations in order to document the necessary good health required to remain on flight status.

4. In addition, since individual responses to any type of medication are difficult to predict even in the healthiest population, the military requires a documented predeployment ground test, conducted under the supervision of a military physician, to guard against problematic idiosyncratic reactions.

5. In the operational environment, qualified medical personnel control the supplies of dextroamphetamine, dispensing it in appropriate amounts when needed and documenting its use in carefully maintained records. These personnel collect unused medications upon mission completion and secure them as appropriate.

6. The ultimate decision regarding whether or not to use dextroamphetamine during an operational mission always rests with the individual aircrew member. No one is ever required to ingest a stimulant.

7. Medical personnel authorize the use of dextroamphetamine as a fatigue countermeasure only after exhausting every other nonpharmacological option. The military never turns to drugs as the first solution to a fatigue problem in the field and does not consider them a substitute for planning adequate crew work/rest.

8. Ultimately, with all options on the table, leadership, in collaboration with appropriate medical personnel, carefully considers the option of using stimulant medications in terms of the criticality of the mission, the potential for known hazards, and the ultimate safety of affected personnel.

Does this list of safeguards optimize the ethical use of dextroamphetamine (and, potentially, other medications) in operational aviation contexts? By following these guidelines, we mitigate the known dangers of fatigue with a scientifically proven method validated by laboratory studies and field testing. Every individual receives a predeployment test dose to guard against idiosyncratic side effects. Therefore, we achieve the ethical principle of "doing no harm." The decision to utilize the medication in support of an operational objective is made jointly by the leadership, the physician, and the individual war fighter to ensure that operational concerns do not over-ride the safety and health of crew members. Thus, the medical community demonstrates trustworthiness and responsibility towards our military personnel. Prior to administering the medication (or making it available) to individuals, medical personnel obtain documented informed-consent agreement, the information contained therein based on currently available scientific knowledge about the positive and negative effects of dextroamphetamine. Thus, this process conveys truthful, accurate, and honest information to personnel. Upon authorization of dextroamphetamine, aviators throughout the affected unit have access to the drug, making the benefits of this fatigue countermeasure equally and justly available to everyone in the group. Finally, no individual aviator is ever required to use dextroamphetamine, and, most often, when the time to decide comes, the individual crew member does so privately, in light of his or her perceived needs during the actual flight mission (when neither the flight surgeon nor the unit commander is present). Thus, the policy essentially respects the principle concerning privacy, general well-being, and self-determination. (22)

Conclusions

The US military has the responsibility of balancing operational objectives and individual rights while protecting the health of the force. By its very nature, achieving this balance can prove challenging, particularly during stressful and fatiguing combat operations. However, the military has dedicated a substantial amount of work to the development and implementation of comprehensive fatigue-management programs that employ administrative, behavioral, and pharmacological strategies. When all else fails, the medication option offers an important counterfatigue intervention, but in today's "just say no to drugs" climate, pharmacological treatments often seem to create an opportunity for spirited debate. However, with regard to the use of medication for performance sustainment, the military has developed a conservative approach designed to meet organizational objectives without compromising individual autonomy or well-being. As I have shown in this article, clear guidelines on the use of stimulants (and, by inference, other counterfatigue medications) in operational contexts optimize the safety, performance, and general well-being of the US military's combat-aviation personnel while preserving their right to make informed decisions about their own lives. Recent survey data suggest that the current policy is working and that there is little perceived pressure to use stimulants if individuals have personal misgivings about doing so. (23) This finding, in combination with the fact that untreated fatigue has cost numerous lives throughout the years but that stimulants have never been implicated in a single Air Force mishap, makes a strong argument for the ethics of continuing to employ counterfatigue medications.

Notes

(1.) Randall D. Katz, "Friendly Fire: The Mandatory Military Anthrax Vaccination Program," Duke Law Journal 50, no. 6 (April 2001): 1838, http://www.law.duke.edu/ shell/cite.pl?50+Duke+L.+J.+1835.

(2.) The Food and Drug Administration approved pyridostigmine bromide for the treatment of myasthenia gravis but considered it an investigational pretreatment medication for organophosphate poisoning. Although some media reports suggested that this medication was significantly associated with so-called Persian Gulf Syndrome, the actual incidence of untoward neurological side effects was 1 percent.

(3.) D. O. E. Gebhardt, "Off Label Administration of Drugs to Healthy Military Personnel: Dubious Ethics of Preventive Measures," Journal of Medical Ethics 31, no. 5 (May 2005): 268.

(4.) Tina-Maire O'Neill, "US Pilots Blame Drug For Canadian Bombing," Sunday Business Post Online, 19 January 2003, http://archives.tcm.ie/businesspost/2003/01/19/ story437452528.asp.

(5.) Michael B. Russo, "Recommendations for the Ethical Use of Pharmacologic Fatigue Countermeasures in the U.S. Military," Aviation, Space, and Environmental Medicine 78, no. 5, sec. 2 (May 2007): B119.

(6.) Erich Roedig, "German Perspective: Commentary on 'Recommendations for the Ethical Use of Pharmacologic Fatigue Countermeasures in the U.S. Military,'" Aviation, Space, and Environmental Medicine 78 no. 5, sec. 2 (May 2007): B136.

(7.) John A. Caldwell, J. Lynn Caldwell, and Kecia K. Darlington, "The Utility of Dextroamphetamine for Attenuating the Impact of Sleep Deprivation in Pilots," Aviation, Space, and Environmental Medicine 74, no. 11 (November 2003): 1125-34; and John A. Caldwell et al., "Modafinil's Effects on Simulator Performance and Mood in Pilots during 37 Hours without Sleep," Aviation, Space, and Environmental Medicine 75, no. 9 (September 2004): 777-84.

(8.) Russo, "Recommendations for the Ethical Use," B123. The term safe within this context refers to the fact that the medications have been tested in controlled laboratory environments as well as in clinical trials and have been determined not to cause physiological harm to the individual. Also, the claim of "safety" is based on the fact that controlled simulator and in-flight studies conducted on military pilots have produced evidence that cognition and performance are not adversely affected by the drug. In fact, results have shown that it improves performance. Lastly, we have evidence of "safety" across individuals since every pilot who uses a prescription stimulant in combat must have already satisfactorily completed a test dose of the drug under a physician's supervision.

(9.) In the context of "war," or a US-sanctioned "police action," or other military conflict, enemies of the United States who bear arms against us with the intent of causing harm are not considered innocent.

(10.) See note 8.

(11.) American Psychological Association, "Ethical Principles of Psychologists and Code of Conduct," American Psychologist 57, no. 12 (December 2002): 1060-73.

(12.) John A. Tirpak, "The Force Seeks a New Baseline," Air Force Magazine 86, no. 1 January 2003): 36, http:// www.afa.org/magazine/jan2003/0103force.pdf.

(13.) S. Elliot, "Chief of Staff Shares Views on Global Strike Task Force," Air Force News Archive, 31 October 2001, http://www.combatsim.com/membl23/cnews/arch/ cnewsarc146.htm#chstff.

(14.) David F. Dinges et al., "Cumulative Sleepiness, Mood Disturbance, and Psychomotor Vigilance Performance Decrements during a Week of Sleep Restricted to 4-5 Hours per Night," Sleep 20, no. 4 (1997): 274, http:// www.journalsleep.org/Articles/200403.pdf.

(15.) Greg Belenky et al., "The Effects of Sleep Deprivation on Performance during Continuous Combat Operations," in Food Components to Enhance Performance, ed. Bernadette M. Marriott (Washington, DC: National Academy Press, 1994), 128.

(16.) Jeffrey S. Durmer and David F. Dinges, "Neuro-cognitive Consequences of Sleep Deprivation," Seminars in Neurology 25, no. 1 (March 2005): 117; and Tom Luna, "Fatigue in Context: USAF Mishap Experience," Aviation, Space, and EnvironmentalMedicine 74, no. 4 (April 2003): 388.

(17.) Lt Col Rhonda Cornum, Dr. John Caldwell, and Lt Col Kory Cornum, "Stimulant Use in Extended Flight Operations," Airpowerjournal11, no. 1 (Spring 1997):54-55, http://www.airpower.maxwell.af.mil/airchronicles/apj/ apj97/spr97/cornum.pdf.

(18.) Kory Cornum, Rhonda Cornum, and William Storm, "Use of Psychostimulants in Extended Flight Operations: A Desert Shield Experience," in Advisory Group for Aerospace Research and Development (AGARD) Conference Proceedings 579 (Neuilly sur Seine, France: North Atlantic Treaty Organization, October 1995), 37-1 to 37-4.

(19.) Brig Gen Gary H. Murray, commander, Air Force Medical Operations Agency, to Department of the Air Force, letter, 26 June 2001 (policy letter on the implementation of Headquarters USAF/XO message on countermeasures to aircrew fatigue in the combat air force).

(20.) Department of the Air Force (Maj Stephen Moulten, point of contact), to Air Combat Command, letter, 20 February 2001 (policy letter on aircrew fatigue-management program).

(21.) This same guidance applies to the use of modafinil (Provigil), recently approved by the Air Force surgeon general for certain Air Force combat-aviation operations. (No doubt the other services will soon approve it as well.)

(22.) A couple of caveats deserve note here: (1) Of course, when the pilot is asked at the conclusion of the flight to account for the medications issued, the flight surgeon will then know the in-flight decision that he made; however, this will occur after the fact (which would lessen its influence at the decision-making point). (2) No doubt, in some situations one crew member could feel "pressured" to use a performance-sustaining medication because other crew members have decided to do so, but survey data suggest that this is more the exception than the rule (see note 23).

(23.) Sarady Tan and John Caldwell, "A Survey of the U.S. Air Force Aviation Personnel on Flying, Fatigue and Fatigue Countermeasures," Aviation, Space, and Environmental Medicine 77, no. 3 (March 2006): 293.
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Author:Caldwell, John A.
Publication:Air & Space Power Journal
Article Type:Essay
Geographic Code:1USA
Date:Sep 22, 2008
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