When we are ready to send humans deep into space, astronaut health and safety will be our top priority.

Daniel S.Goldin, NASA Administrator

Speaking at the U.S. National Academy of Sciences

October 25, 1999

Space is the most extreme environment that humans have ever entered. A prolonged presence in microgravity results in a number of adaptations that may not be completely reversible. Space crews are isolated and spacecraft provide limited room in which to live and work. Future exploration of the solar system may require crews to land on other planets (such as Mars) or to establish colonies on other bodies in space (such as the Earth’s Moon). Currently, radiation protection in deep space is an unsolved issue, and the threat of dysbarism is ever present, especially during extravehicular activities. Traditionally, the National Aeronautics and Space Administration (NASA) has depended on a preventive approach to astronaut health, re-

flected in strict astronaut selection standards and close monitoring of astronaut health status. This has proved adequate for short-duration space missions, and NASA crews have been essentially free of major illness during the missions. To date, few urgent medical problems have occurred, and the spacecraft has always been within a day or several days of return in case of a serious emergency. This may not be the case during long-duration missions.

With long-duration space missions the number and variety of health conditions facing astronauts who may require medical intervention before, during, and after space travel will continue to expand. There are medical conditions that have the potential to seriously impair the ability of astronauts to function in the spacecraft, during egress, while working outside the spacecraft, and upon the return to Earth. With increasing mission lengths, the chance of an acute medical emergency such as appendicitis, pneumothorax, or acute mental impairment increases, as does the necessity for medical intervention within the spacecraft. Relevant questions include the following:

• What are the physical and behavioral attributes best suited for longduration space travel?

• How do the series of preventive measures necessary for a long trip differ from those designed for shorter space travel?

• How should methodologies and technologies for care evolve?

• Are there health care issues especially pertinent to landing or colonization that are different from those pertinent to extended travel in a spacecraft?

To support extended space travel, NASA’s medical care system must, at a minimum, maintain the health of each crew member so that she or he can (1) function as a productive member of the crew, (2) retain acceptable health during and upon completion of the spaceflight, (3) egress from the spacecraft, and (4) maintain orthostatic tolerance during deorbiting and landing (briefing, Johnson Space Center, February 2000). Although these goals are consistent with those of space travel of any duration, how they are attained differs. For example, for missions of the space shuttle, what is reasonably required is modest ambulatory care, first aid, and rudimentary “life support.” On the International Space Station (ISS), additional components, including more advanced life support, stabilization, and transport, are necessary. Beyond Earth orbit, there is the further necessity of definitive treatment, rehabilitation, and chronic care because of the inability of return to Earth for many months. The methods necessary to achieve these goals are

not yet developed. In addition, the full array of health conditions that must be prepared for, although under intense study by NASA and described in part in Chapters 3 and 4 of this report, have not been fully catalogued, nor have those that have been identified been addressed adequately.

Why does NASA need a comprehensive health care system for space travel? There are two reasons: deep space is a unique environment with special hazards for humans, and at this point, humans are thought to be necessary for an exploratory mission. The environment is unique in several ways. The most salient one is that humans have not been beyond Earth orbit for prolonged periods, and as mentioned in other sections of this report, not enough is yet known about the effects of prolonged exposure to microgravity on humans to send them there safely. For this reason the Institute of Medicine Committee on Creating a Vision for Space Medicine During Travel Beyond Earth Orbit has strongly recommended the use of the ISS as a platform for clinical research on the effects of microgravity and for validation of countermeasures. In addition, technological problems, such as radiation protection, remain unsolved, making long-duration space travel probably unacceptably dangerous. Finally, although all previous voyages of discovery on this planet have had, to greater or lesser degrees, the availability, outside the craft, of food, water, and air and a means of waste disposal, the impossibility of a reasonably speedy return means that all that is necessary for prolonged maintenance of life must be contained within the spacecraft.

Although there is debate within the scientific community of the necessity of sending humans on long-duration exploratory space missions, the committee assumes for the purposes of this report that humans will be sent. Given that assumption, there is the obvious necessity to keep them functioning productively. In addition, there is the ethical imperative that they return to Earth in acceptable health. The committee strongly believes that the success of the mission and the successful return of healthy individuals demand, on the basis of risk analysis and management of the evidence base, the highest reasonably attainable standard of health care with the resources available before, during, and after such a mission.

Providing the highest reasonably attainable standard of health care for astronauts during long-duration missions beyond Earth orbit will require an effective organizational framework that integrates health care for astronauts with an effective health care research strategy.

The committee reviewed two documents that provide a portion of the conceptual framework for this section. The two documents, Resources for the Optimal Care of the Injured Patient (ACS, 1999) and Model Trauma Care System Plan (DHHS, 1992), address Earth-based care for a specific category of patient: patients with acute injuries. These documents are relevant because they describe acute care for the most urgent medical needs that may occur during space travel and because they describe the framework or infrastructure that an adequate health care system must have to meet those needs. The documents also represent examples of what may be learned from fields outside those to which NASA has normally turned for advice and, in the case of the document from the American College of Surgeons, emphasize the importance of periodic updating of standards and procedures on the basis of new knowledge and theory.

The committee’s perspective on leadership is based on the training and experience of its members. That background emphasizes two values relevant to the issue of leadership: that someone is in charge and that continuity is a key component of health care. “In charge” requires both accountability for and authority over the funding needed to make all pertinent decisions with respect to the health of the astronaut corps. “Continuity” means that the health care system provides for the continuity, over time and space, of the health care of astronauts.

It is the intent of the committee to address the principles that it believes are necessary for an effective system for astronaut health care. The committee intends no judgment, positive or otherwise, of the current structure or of the individuals currently holding positions within NASA. Indeed, the NASA organizational structure dealing with astronaut health underwent substantial changes during the time of the committee’s study. These include a Johnson Space Center (JSC) proposal for a Bioastronautics Institute to coordinate research and health care and the designation of a NASA chief medical and health officer to provide health and medical policy oversight. Although the committee renders no opinion on the validity of these specific steps, it commends NASA for recognizing the need for change and believes that these steps could be appropriate in meeting the concerns that the committee developed in the course of its discussions. The committee is concerned, however, that the present organizational structure has not yet evolved to the level necessary to ensure astronaut health and safety during travel in deep space.

Developing a framework within which a health care system for astronauts can evolve is best accomplished through the designation of a single organizational component. Whether this component is internal or external to NASA, it should be headed by an individual with the appropriate training, experience, and authority (1) to develop the system along with standards for performance; (2) to coordinate all related external and internal resources, including basic, translational, and clinical biomedical and behavioral research; and (3) to administer the component’s policies and procedures. The committee is concerned that fragmentation of the necessary elements of the framework will work to the detriment of the health of the astronauts. Important to the committee in this regard are the elements of coordination with other organizational units within NASA, integration of astronaut health with other components of the space mission, and authority to determine what is in the best interests of astronaut health.

The committee learned of numerous examples of a lack of coordination among different organizational components of NASA. One pertinent example, also commented on by the Space Studies Board (SSB and NRC, 1998a), is the lack of coordination among the Ames Research Center, JSC, and National Space Biomedical Research Institute (NSBRI) for countermeasure development, the process that NASA views as being critical in providing answers to unsolved clinical questions. It is understandable that in any large and complex organization different components may work on similar issues. It is also notable that JSC and NSBRI have begun to coordinate countermeasure development. Nevertheless, for many reasons, including that of the difficulty of making general and prospective valid conclusions from a small number of observations or with a small amount of data (the problem of studies with small numbers of participants, that is, the “small n” problem mentioned in Chapter 2), it behooves NASA to coordinate all activities related to astronaut health.

The work of NASA originated in engineering, and its most stunning successes have been technological. Indeed, the committee heard in discussions with astronauts that even the most biologically oriented of astronauts,

the physician-astronauts, identify themselves first as astronauts and then as physicians. In discussions with NASA officials, staff, and astronauts, however, the committee learned of several instances in which the human component of space missions was given, at best, short shrift. For example, the committee believes that the habitability of the spacecraft becomes a critical issue on missions that could take as long as 3 years. The committee believes that improvements in this area, as well as many others, would benefit from a greater degree of integration among the various components of NASA. As the committee has noted throughout this report, biology and engineering are moving closer together, in theory and in practice, as nanotechnology benefits damaged biological systems and as the biological concept of self-repair enters engineering. This transition represents an opportunity of historic proportion, but its benefits require organizational integration.

The risks to the health and the lives of astronauts on long-duration missions are substantial. That factor alone should require the establishment of an organizational component with a named individual accountable for astronaut health. The organizational component should have significant and substantial input from the astronauts. The organizational component would be even more effective and would be trusted by astronauts even more if the astronauts themselves had some input into the selection of the individual responsible for their health and some ongoing input into that individual’s performance review. Astronaut input would be in an advisory and consultative capacity, not in a controlling or managing capacity, and would give real credibility to the stated commitment to make astronaut health and safety the highest priority of the mission. Furthermore, the individual accountable for astronaut health must have authority sufficient to ensure that all appropriate steps are taken to maintain the health of astronauts.

The committee believes that the element of authority is of sufficient importance to require that the individual have both operational authority and budgetary authority, with checks and balances provided in part by internal NASA mechanisms and supplemented by an external advisory group modeled on advisory groups of the National Institutes of Health (NIH) and other federal external advisory groups, for example, those at NASA, the Office of Naval Research, the U.S. Department of Defense (DOD), and the Environmental Protection Agency. The qualifications of the individual should include a knowledge base in space medicine, experience with the administration of a health care system or a major component of a health care

system, and a clear understanding of the important role of research. Given the relatively limited opportunities to do clinical research in space, efficient research prioritization and administration are critical.

The committee considered alternative frameworks within which an organizational component responsible for all aspects of astronaut health might evolve. The framework could be external (for example, it could be a component of a larger external health care system, established through a contractual arrangement, or part of a public-private group such as NSBRI), or it could be internal to NASA and could be located at JSC or NASA headquarters. Each type of organizational framework has its own advantages and disadvantages.

Astronaut health care as a component of a larger health care system NASA could partner with an existing federal health care system with specialized knowledge applicable to NASA’s needs in aerospace medicine, such as the one within DOD, or it could partner with the Federal Aviation Administration (FAA). The National Science Foundation (NSF) has in the past used resources of the U.S. Navy to provide health care during NSF long-duration overwintering missions in the Antarctic. The advantages of this type of arrangement would include the use of an established, comprehensive, and evolving working system. The disadvantages are those associated with the use of any external system, for example, a lack of or a decreased familiarity with and specificity for the needed task, a lack of flexibility to evolve with space medicine, a lack of confidentiality, limited degrees of budgetary authority and policy-making ability, and a lack of familiarity with the international space medicine community. The greatest disadvantage of an external system is its diminished capability to coordinate with the health care research strategy of NASA to produce clinically relevant information so that NASA can provide the highest reasonably attainable standard of health care for astronauts during long-duration missions beyond Earth orbit.

Astronaut health care established through a contractual arrangement NSF is providing health care in Antarctica through a contractual arrangement. Along the same lines, NASA is using Wyle Laboratories to manage its Countermeasure Development and Validation Project and could expand this ar-

rangement to include management of a comprehensive health care system for astronauts. Although the existing arrangement with Wyle Laboratories is an advantage in terms of the contractor’s familiarity with the task, Wyle Laboratories’ specialized focus on countermeasures is a potential conflict, and no NASA contractor-based health care system that could be built upon is in place. Contracting with an established nonfederal health care system or organization to provide comprehensive health care for astronauts would have a mixture of the advantages and disadvantages described above for an established federal health care system, particularly the diminished capability for integration of clinical information and clinical research into the health care research strategy of NASA.

Astronaut health care as part of a public-private group NSBRI is responsible for research in countermeasure development. Its task could be expanded to include the management of a comprehensive health care system for astronauts. Its university members provide expertise in a wide variety of areas, although they are selected to provide expertise in basic and translational clinical research. The resources of an established health care system, however, are not present and would have to be developed; and the potential disadvantages described above for partnering with an established federal health care system external to NASA would also be present.

The existing components within NASA that provide health care for astronauts could continue to evolve into a comprehensive health care system for astronauts. The physical facilities and basic organizational structure proposed for the Bioastronautics Institute, described to the committee during its visit to JSC, indicate that the Bioastronautics Institute would be an attractive alternative as the organizational component that could provide comprehensive health care for astronauts. NASA should continue to study this alternative. It would represent an evolution of existing programs, would be close to the astronauts, and would likely be able to gain astronauts’ confidence more easily than an external system would. It would be more amenable to providing flexibility, interpersonal communication, and the degree of confidentiality needed. It would also have more budgetary, operational, and policy-making authority and would have a greater ability to coordinate with the external research and international communities than an external organization would.

NASA has several frameworks to consider as it continues to build a comprehensive health care system for astronauts. Whatever framework NASA decides upon, it must lead to reduced fragmentation and increased communication at all levels and must provide the highest level of health care for astronauts.

The committee’s logic in its assessment of the organizational structure needed to ensure astronaut health and safety is as follows: a voyage of exploration into deep space that would last for up to 3 years is of a different order of magnitude and is a different kind of mission than has ever been attempted. Without effective countermeasures developed from basic knowledge of biological and clinical processes, humans would likely not survive such a mission. For the past 40 years and to the present, NASA’s organizational structure has missed critical opportunities to collect and analyze relevant human clinical data, data that if collected and analyzed would likely have placed NASA closer to solving the necessary clinical and engineering issues.

The committee believes and reiterates here that to ensure a successful long-duration mission into deep space, all that can be done to collect and analyze relevant clinical and basic biomedical data must be done. Thus, the committee has recommended a two-pronged strategy of (1) development of a comprehensive health care system to collect clinical epidemiological data and (2) development of a strategic biomedical and clinical research plan to collect and analyze data on health risks and their amelioration. Integration and coordination of these two components are, in the committee’s view, absolutely necessary. Such integration and coordination are best overseen by a single qualified individual with sufficient authority.

After considering the evidence and testimony presented to it during the meetings conducted for preparation of this report, the committee strongly believes that a major revision of NASA’s organizational structure is needed to provide for the optimum health and safety of astronauts for future long-duration missions beyond Earth orbit. The committee believes that NASA needs a single organizational component whose head has overall responsibility for the health and safety of astronauts. Operational or line responsibility for astronaut health care and clinical research would likely rest with two different individuals, who would report to a single individual. That individual’s responsibility would be to coordinate, oversee, and set policy

for all astronaut health care and clinical research, similar to the lines of authority and organization at the U.S. Department of Veterans Affairs and at NIH. In reaching this decision, the committee considered several alternative organizational possibilities, as described above. The committee believes that a single organizational component within NASA has the best potential to achieve the evolving framework needed to coordinate with other organizational units within NASA and integrate all aspects of astronaut health and safety with other components of the space mission. The unit would also possess the authority to make decisions in the best interests of astronauts and their health. The committee is mindful of the fact that it is advancing a major structural change that may involve shifts of power and that will involve readjustment of significant resources. The change will, in the considered judgment of the committee, allow NASA and the international space community to build a better-integrated comprehensive system of health care to provide for the best possible health and safety of all astronauts who travel beyond Earth orbit.

• Astronaut health and performance will be central to the success of long-duration space missions, but the responsibility for astronaut health and performance is buried deep within NASA.

• Within NASA the focus on health care research and astronaut health care is not sufficient, nor does NASA sufficiently coordinate and integrate the research activities needed to support successful long-duration missions beyond Earth orbit.

• have authority over basic, translational, and clinical biomedical and behavioral health research;

• foster coordination between NASA and the external research community; and

• be overseen by an external advisory group, modeled on advisory groups of the National Institutes of Health and other federal external advisory groups, to provide program review, strategic planning, and leverage to assist NASA in meeting its goals for astronaut health.

To develop a successful functional health care system for astronauts, two components are necessary: systems planning and system operations (Box 7–1). These processes afford an opportunity to systematically develop the elements of a comprehensive system and to allow consensus to build around the program.

NASA already has in place a process, the Critical Path Roadmap project, in which astronaut health care issues are identified and mechanisms for addressing those issues are developed. A similar process could profitably be applied to the development of an infrastructure for a health care system for astronauts. Such a process could be used to identify needs and evaluate resources.

A process for development and implementation of a health care system for astronauts that covers the continuum from premission, mission and postmission and that provides for systematic review should be established. A systematic review process is especially important since although the infrastructure for a comprehensive health care system for astronauts may be put in place in the near term, the implementation of portions of a comprehensive health care system for astronauts during long-duration missions is decades away.

Standards of care must be developed. Although a process is under way within NASA, there is not yet a clear statement of what the standard of health care for astronauts on long-duration missions should be or what practical limitations to that standard may exist. Perhaps most vexing is the probable international nature of any long-duration mission and the different ways in which different cultures view risk. Thus, the goals should be defined with all appropriate parties involved. An implementation plan, with an approval process and a timetable, should be developed.

Most important, in the committee’s view, is a description of how all interested parties and external advisers will participate in the planning process. The reason for this is based largely on the committee’s discussions with NASA staff and on anecdotal evidence that NASA as an organization is perhaps more insular than it should be. The committee believes that the interaction of humans and machines will be even more critical during long-duration space missions than on short-term spaceflights.

There should be a clear description of the process for establishing, implementing, and updating policies, procedures, and protocols. This should include descriptions of how the different operational units will relate to each other and how their activities will be integrated. In addition, the mechanisms for cooperation with other components of government should be described. NASA should continue the series of cooperative agreements with NIH, DOD, and other agencies that it has already instituted.

Given the committee’s perspective that long-duration missions beyond Earth orbit present unique issues, the time appears to be appropriate to review the legislative authority and legislative interpretation of NASA’s programs to ascertain whether some modification is advisable. Three areas may be especially appropriate.

A principal recommendation of the committee concerns the acquisition and treatment of astronaut health data and the application of occupational health principles to those data. The gathering of health data and their analysis are crucial to the success of being able to provide appropriate health care. NASA staff have cited two federal statutes, the Privacy Act and the Freedom of Information Act, and principles of medical confidentiality as constraints on the collection and full analysis of astronaut clinical data. Either the acts themselves or overly conservative interpretation of them has limited the acquisition of data necessary for the protection of astronauts and future space crews. If it is the former, consideration should be given to modification of the statutes in a way in which “need to know” is the guiding principle. If it is the latter, NASA should reevaluate its interpretation of the acts. NASA should also consider using the reporting requirements for occupational health data.

Elsewhere in this report the committee expresses the concern that NASA has not cast a wide enough net in seeking external advice. Although a number of advisory committees exist throughout NASA, including the NASA Advisory Council and the Life and Microgravity Sciences and Applications Advisory Committee, advice related directly to medical issues appears to come from the Medical Policy Board. The Medical Policy Board is composed solely of government employees, mostly physicians. The committee suggests that NASA consider whether modifications to this policy structure is advisable by including members who are not federal employees to provide broader expertise and advice in ensuring protection of astronaut health and ensuring astronaut safety.

One of the committee’s principal recommendations is for NASA to develop a strategic clinical research plan. Presently central to NASA’s biomedical research program, including its clinical research program, is NSBRI. NSBRI, chartered as a nonprofit corporation under Texas law, includes a consortium of academic institutions; it also has relationships with industry. The committee believes that NSBRI has the potential to foster fundamental research into the critical clinical questions facing astronauts on long-duration missions beyond Earth orbit. Although the committee makes no recommendation concerning the detailed research structure of NASA, NASA should consider whether the current structure of NSBRI and its legislative authority are appropriately effective in achieving NASA’s research goals.

The total fiscal year 2000 funding for NASA-supported programs in biomedical research and countermeasures was approximately $57 million. This figure does not include support for NSBRI from other sources, nor does it include research sponsored by other agencies of the federal government. Measured against the overall NASA budget of nearly $14 billion, in which technological systems dominate, the amount is small. Given the committee’s conclusion that unless critical clinical problems are solved humans cannot safely “fly” on long-duration missions beyond Earth orbit, NASA should reconsider its research funding priorities.

The role of the human component of space missions needs to be upgraded. By this, the committee intends three points: (1) engineering and biological perspectives need to be brought into better balance, (2) sufficient priority needs to be given to learning what is necessary to send humans safely on long-duration missions, and (3) the success or failure of long-duration exploration missions beyond Earth orbit is dependent upon humans. As good as technology is (and it is quite good), successful missions continue to depend on human expertise and ingenuity in solving problems. Examples include the successful return of Apollo 13, the repair of the Hubble Space Telescope, and most recently, successful deployment of the solar panels on the ISS.

The committee suggests that NASA consider whether its current struc-

ture and priorities adequately reflect the importance of the human component in space. In addition, it should consider whether organizational coordination, integration, and authority meet the criteria suggested in the section on leadership above.

It is the opinion of the committee that the importance of external relationships in accumulating necessary data, communicating necessary information, dealing with international partners, and obtaining advice is worthy of comment.

Expanding capabilities, freeing resources to do what only NASA can do easily, building more inclusive networks, staying abreast of the newest innovations and relevant trends, encouraging others including the next generation to participate in development of the field, and open and strong public communications are essential to the success of any large endeavor like human exploration of deep space. Until relatively recently, NASA had not used other agencies of the federal government for the accumulation and development of clinically important information. The committee believes that cooperative agreements with NIH should continue and should be expanded. For example, there is intense interest in many NIH institutes to increase knowledge of osteoporosis and its causes. At present and in the past there has been considerable interaction between NASA, the National Institute on Aging, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. These interactions should be encouraged and enhanced to address the important issue of bone loss during space missions and to help provide information about osteoporosis in general.

The research resources of NIH, both in terms of funding and in terms of infrastructure for biomedical research, are far greater than those of NASA and could appropriately be used to support basic and clinical research that meets the priorities of both institutions. Not only can NIH-sponsored research help address clinical issues pertinent to long-duration space missions, but NASA-sponsored research in microgravity also can benefit NIH’s mission in fundamental biomedical research. Another agency, in addition to DOD, that has been involved in aviation-related data collection is FAA. FAA, whose aviation medicine component regulates and approves medical

certification for civilian aviators, might have clinically important information that NASA could use.

Although NASA should be very proud of its accomplishments in space medicine, more formal collaborations with NIH and perhaps other research agencies within the U.S. Public Health Service and the federal government would be well worth considering. Some of these collaborations might be at a simple administrative level (greater use of joint study sections to review grants and contracts), and some might be accomplished by greater involvement with NIH intramural programs through formal interagency agreements. There is also perhaps a need to focus on greater collaborations with the private sector in matters relating to genotyping, gene expression, and proteomic profiling in the context of space medicine.

There is a need for information on the actions of pharmaceuticals in microgravity. As noted by the National Research Council’s Space Studies Board and in information provided to the committee, there have been anecdotal reports of altered drug efficacy on short-duration space missions. Although the Space Studies Board did not address clinical pharmacology in detail, it did recommend carefully designed clinical research. No data exist on whether drug action in microgravity is similar to that on Earth or which drugs may be most appropriate for inclusion in a formulary. Because of the increased importance of curative pharmaceuticals on a long-duration mission, cooperative arrangements with the pharmaceutical industry would appear to be appropriate and cooperatively designed experiments would appear to be mutually beneficial. The initial focus of cooperative research in this area would not be efficacy but would be whether the actions of existing efficacious drugs are altered in microgravity.

Development of an onboard formulary is a different, but no less important, matter. It will be impossible to carry every possible pharmaceutical agent on a long-duration mission. Thus, it will be necessary to choose what to take and, possibly in the future, to determine what will be able to be synthesized on a mission. Many organizations both within and especially outside the federal government have addressed formularies for their own patient populations and presumably have processes for formulary development. The U.S. Department of Veterans Affairs, the DOD, and many university-related managed health care plans might offer helpful advice.

Information development applies not only to scientific or clinical knowledge but also to knowledge of processes and models. NASA has begun to develop clinical protocols, which are of tremendous value in clinical practice. Because there may be limited clinical experience among the astronauts within the spacecraft and because of the significant delay in radio or even

more advanced means of transmission during missions beyond Earth orbit, it is anticipated that clinical protocols (practice guidelines) will be the basis for medical decision making. Significant advances in guidelines development have occurred in the past two decades. The Agency for Healthcare Research and Quality (AHRQ) within the U.S. Department of Health and Human Services has been a leader in this area; cooperation between NASA and AHRQ could enhance NASA’s work in this area. In addition, DOD has substantial practical experience with clinical protocols. The committee heard specifically of the utility of clinical protocols administered by corpsmen in submarines. Further collaboration between NASA and DOD would similarly be useful, as would collaboration with the U.S. Department of Veterans Affairs with its experience with clinical guidelines, clinical protocols, informatics, and performance measures.

The health care systems for individuals in extreme isolated terrestrial environments—Antarctica, submarines, and the deep sea where divers work (see Appendix A)—share common structural characteristics. The committee believes that NASA could continue to learn from these analogs in developing its own health care system. In addition, the branches of the armed services have a long history of working in extreme situations and in developing model systems (IOM, 1999a). For example, most of what is known today about trauma surgery was developed on the battlefield. Furthermore, the military model of the organization and delivery of medical care may provide further insights into NASA’s nascent organization of a model for health care during long-duration space missions.

Although exploration and discovery hold special places in the human psyche, space holds a fascination. Symbols of that fascination abound, from the National Air and Space Museum, to the NASA-dedicated cable television channel, to hit films such as Apollo 13, to programs about space on The Discovery Channel. Nor was the committee immune to that fascination. NASA has done an excellent job in building on this fascination, from the first lunar landing to the construction of the ISS.

NASA should pay increased attention to two areas of public communication, however. These are the communication of the benefits of research in space and the communication of risk. Both research support and research cooperation are often dependent on the perception of benefit. The committee heard from NASA staff that support for biomedical research was lacking

from the scientific and political communities. The committee believes that cooperative agreements, coupled with a clear statement of the benefits of research in space medicine, would enable NASA to gather additional support for the necessary research.

Much more important in the view of the committee is the need to communicate risk. Spaceflight is inherently risky. Long-duration space travel, especially that beyond Earth orbit, entails known as well as unknown risks. The committee believes that there is a profound professional and ethical responsibility to evaluate honestly the risk to human life that will be incurred as a result of extended space travel. Although the risks must be evaluated in the context of the benefit to humans, they must be stated on an individual human level in terms that can be plainly understood. NASA states that the issue of risk is a high priority. The determination of what risks to humans exist and what countermeasures should be developed is being addressed initially through NASA’s Critical Path Roadmap project. Nevertheless, the present committee report touches on other information that must be developed and other mechanisms that should be used before the goal of optimally achievable safety to humans on long-duration missions is approached. Of equal significance is how, in a truly informed and deliberative way, an individual astronaut may come to a personal decision to accept the risk of a maiden voyage to, for example, Mars. This issue is further discussed in Chapter 6.

From the perspective of society, the committee believes that risks and benefits must be addressed and communicated explicitly. The public should be made aware of the risks to astronauts, as well as the benefits, of space missions. Five centuries ago, a voyage west from Europe was, to some, a voyage off the face of a flat Earth, a voyage necessarily doomed to tragedy. A century ago, Antarctic explorers faced clear odds against survival. Today, for every ten people who successfully summit 8,000-meter peaks, one or more dies (The New York Times, 2001). Every day individuals voluntarily take risks of a degree that they would not take if another party required them to take those risks. Yet, many in the United States assume that there are activities that should be risk-free. The public must be prepared for the possibility that all countermeasures may tragically fail and that a crew may not return from a prolonged space mission. The public must also be prepared for the possibility that on the astronauts’ return to Earth, normal functioning in some areas may not return for a long time and in some cases may possibly never return. Although NASA has identified risk as an issue that it needs to address, the committee concludes that a greater emphasis must be placed on

communicating health risks to astronauts and to informing society not only of the benefits but also of the risks of space travel.

Given the uniqueness and complexity of long-duration missions beyond Earth orbit, it is anticipated that there will be a need for increased international cooperation to achieve success. What is learned on the ISS will be applicable to such long-duration missions. The committee’s recommendation that the ISS be a platform for clinical research stresses the importance of the following recommendation of the Space Studies Board (SSB and NRC, 2000, p. 78): “Mechanisms are needed to ensure that protocols and facilities for pre- and postflight monitoring and testing are consistent across national boundaries. There have to be common criteria for evaluation and utilization of countermeasures and international cooperation in their development.” The committee would add that medical care, as practiced on the ISS and on long-duration missions beyond Earth orbit, must also be consistent for individuals of all nationalities.

On the basis of the committee’s recommendation that a comprehensive system for astronaut health be established, it recommends that a NASA external advisory board, committee, group, or panel whose sole concern is astronaut health be established. Because of the small n problem and the limited amount of research that can be carried out on the ISS and during space shuttle flights, it will likely never be possible to develop a knowledge base of information important to astronaut health to the level of validity and reliability to which researchers may be accustomed in other circumstances. The small n problem, and approaches to solving it, are discussed in the IOM report, Small Clinical Trails: Issues and Challenges (IOM, 2001e). An external advisory group on astronaut health whose role is to act as ombudsperson for astronauts and that has the expertise to understand not only the complex issues of space medicine but also the importance of continuing research would serve as a check and balance to the inappropriate use of astronauts during missions. It would also support when missions must go forward even in the absence of perfect information. Such an advisory group, external to NASA, could also ensure that

• the health and safety of the astronauts are priorities;

• operations are rigorous in terms of health care system design and ongoing modification;

• research is coordinated and appropriate;

• data collection, retrieval, and analysis are seamless and data are linked to policy and practice;

• methodologies of continuous quality improvement are used; and

• regular reports on the health care program itself are provided to the full NASA community.

A separate reason for an external advisory group on astronaut health is the need to stay abreast of new and emerging scientific knowledge. The two decades before an interplanetary mission will likely occur will see not only massive amounts of new and relevant basic and clinical information but also the coming and going of concepts and practices of health care delivery and technologies that support that care. Clinical practice guidelines cannot be static but must be updated on the basis of new knowledge, therapies, and technologies. A current example is the Human Genome Project and the effect that it will have on prevention, diagnosis, treatment, and rehabilitation. Other, relatively new, and rapidly developing fields of nanotechnology, noninvasive means of diagnosis and therapy, medical informatics, and so forth have the potential to transform the approach to medical care in space as well as on Earth. NASA should have a mechanism for systematically tracking and analyzing not only the research with which it is directly involved but also research occurring in other fields that may be relevant to its missions.

To accomplish this, collaboration with other research agencies within the federal government, all of which have some degree of incentive to track and compile data from research, would be beneficial. An additional approach is the bringing together of “skunkworks,” an eclectic group of individuals that brainstorms on particular areas and topics on which they are focused as they emerge and a group that, constantly renewed, would have an ongoing advisory function. The committee suggests that NASA look at the role, structure, and usefulness of external advisory groups at NIH and other federal agencies as a guide.

On the basis of the committee’s perspective that deep space represents a unique environment and that the health and safety of astronauts are paramount, the committee recommends a comprehensive, integrated health care

system for all astronauts, active (including those in training to be astronauts) and nonactive (including those who are retired), and their immediate families. A model similar to that of the military, but with modifications, is outlined below. The rationale for such a comprehensive system, in the committee’s view, is based on the degree of risk of long-duration missions to both current and future astronauts and on the practical difficulty of obtaining sufficient clinical data to ensure a reasonable degree of safety for such missions. Comprehensiveness maximizes data collection and tends to diminish risk by promoting solutions. Care for the family is justified both for the reasons defined by the military—for example, as a benefit that augments low pay and that is a necessity in areas where health care may otherwise be unavailable and in a profession where personnel are often subject to geographical moves—and because of the interrelationship between family health (both physical and psychosocial) and astronaut health during the stressful separation while the astronaut is on long-duration space missions.

Comprehensiveness means that all health care for the astronaut is, at a minimum, coordinated through the astronaut health care program and covers all periods while the astronaut is active, including the selection, premission, intramission, postmission, and intermission phases. For the retired astronaut, health care would continue to be available through the astronaut health care program as long as the astronaut chooses. However, participation in NASA’s Longitudinal Study of Astronaut Health should be strongly encouraged by providing explanations about the long-term advantage to the individual astronaut and to those who will follow. Comprehensiveness also means that clinical data will be retrospectively as well as prospectively collected and analyzed. The committee believes that much of relevance can be learned from retrospective review of medical records, mission debriefings, interviews, and stored clinical samples.

A health care system for astronauts should also be integrated. That is, it should include, in addition to a care component, a research and a training component. What is learned from basic and clinical research should be integrated into care plans, and what is learned in the process of care, if relevant, should stimulate research. In addition, since most forms of health promotion and disease and injury prevention depend on the individual, the astronaut should be trained not only in preventive measures but also in routine medical care. Currently, NASA coordinates these functions in its Clinical Care Capability Development Project (NASA, 1998b). This would appear to be an appropriate initiative, but more may be needed, as described below.

The committee believes that the standard of clinical care for a health care system for astronauts should be equivalent to that of the best terrestrial health care system for those problems that occur pre- and postmission and in the intermission phase. The committee is using the best possible medical practice as the definition of standard of care rather than using “standard of care” in the legal term-of-art sense. Standard of care in most states is defined by common law and case law, not by statute. For care during the mission, the standard of care must, of necessity, evolve. For example, should a long-duration mission beyond Earth orbit occur in the near future, the standard would likely be less ideal than it would be if the mission occurred farther in the future, when new knowledge and the further development of prevention and treatment measures, care protocols, and skills could be incorporated. The goals of the care system should be to maximize the individual astronaut’s ability to function as a productive member of the crew during the mission and to maintain or to restore normal function during and upon completion of the mission.

NASA (NASA, 1998a) has outlined a strategy for health care on longduration missions with which the committee’s principles are consonant. The components of that strategy are listed below:

• Determine the expected frequencies of health conditions that will require medical intervention.

• Institute preventive measures.

• Match the severity of the health condition with the treatment necessary to cure or control the condition.

• Determine the level of skill necessary on board to diagnose and treat the expected health conditions.

• Determine the necessary diagnostic technologies (kits, informatics).

• Determine the necessary treatment technologies (drugs, biologies, supplies).

• Develop measures to stabilize a crewmember if cure or control is not possible.

• Develop a plan for disposition of the crewmember in case of death.

• Plan for long-term care of chronic health problems.

• Periodically review the strategy.

The committee accepts the components listed above with the following caveats. NASA has implemented the Critical Path Roadmap project to determine the health conditions requiring medical intervention. The project initially identified 11 “discipline risk areas”: advanced life support; bone loss; cardiovascular alterations; environmental health; food and nutrition; human performance; immunology, infection, and hematology; muscle alterations and atrophy; neurovestibular adaptation; radiation effects; and space medicine. Chapters 2 and 3 of this report address what is known in these fields and how issues in these fields may be approached. Once identified, NASA’s approach to a problem is to develop countermeasures. The committee has concern that use of the concept of countermeasures leads to technological solutions to biological problems. Instead, the committee urges that for a biological problem consideration be given to understanding the fundamental processes leading to the biological problem. Causation can then be ascertained from this understanding, and only then can a solution be defined.

The committee wishes to emphasize an additional aspect of the preflight phase, that of prevention. Primary prevention begins with the proper selection and training of astronauts and astronaut teams for missions (a subject dealt with in detail in Chapter 5 of this report) and the use of engineering design. NASA should continue its validation of these processes to maintain the confidence of the astronaut corps, external bodies, and the public. Secondary prevention is dependent on proper safety standards and good strategies protective against occupational hazards. Both are, in turn, dependent on knowledge of risk. Tertiary prevention is dependent on having well-trained medical personnel and databases on board the spacecraft and access to qualified personnel and other resources on the ground.

An additional point of importance is that of triage, which, to some degree, will govern care during long-duration missions beyond Earth orbit. Historically, triage involves making decisions to maximize the benefits of

care to the group, given the resources available to the group. The committee anticipates that care will be initiated to the maximum available, assuming that planning for the mission has included a level of appropriate diagnostic and therapeutic technologies and materials. (Evidence from the Antarctic experience indicates that the ingenuity of humans enables heroic treatments even beyond that considered possible with the available medical materials.) Initially, the triage principle will come into play in the preflight phase, when decisions are made about the intramission resources that will be available. Other instances in which triage may be invoked are that of a catastrophe involving crewmembers and that involving a decision to withdraw care. Both will require preparation preflight, knowing with certainty that not every possible scenario can be anticipated. Although it is theoretically possible that a planned long-duration mission beyond Earth orbit could be aborted because of the medical condition of a crewmember, the committee considers this unlikely because of the practical difficulty of doing so. Nevertheless, it is valuable to develop guidelines prospectively to address this issue. Medical condition data from the nuclear submarine service could provide the conceptual framework for such guidelines.

Because of the relative paucity of data on the long-term effects on health of long-duration spaceflight, NASA has been unable to predict which, if any, long-term chronic effects will need to be addressed. Use of the ISS as a clinical research platform should help with this endeavor. Initial evidence suggests several areas, some with short-term effects and several with longer-term effects, that may require attention. These include dehydration, neurosensory motor control adjustment, decreased muscle strength and endurance, diminished cardiac reserve, decreased immune response, regional osteopenia, increased risk of renal calculi, and increased risk of radiation-induced cancer. To address these issues, long-term data collection and analysis through strict application of the Longitudinal Study of Astronaut Health are critical. As more is learned from the experiences of astronauts aboard the ISS, standards can be developed on what is normal or abnormal during a space mission as well as what is an acceptable postmission status. Such standards can direct treatment and rehabilitation efforts critical to longer missions.

In a way similar to that in which new techniques and technologies such as laparoscopy, microtechniques, and videoscopy have transformed the skills

required for surgery, medical informatics will transform the medical skills required for diagnosis and treatment, perhaps to an even greater extent. Medical informatics refers to information systems that support prevention, monitoring, diagnosis, decision support, intervention, and treatment. The key elements of such a system are user interfaces and displays, artificial intelligence, automation, smart systems, sensors, data acquisition systems including handheld computer devices, computer-based training, and simulation and a communication infrastructure (NASA, 1999).

NASA is to be commended for having gone beyond simple communication to telemedicine (or medicine at a distance) to exploring the larger role of medical informatics in the space program. Although this conceptual leap and its practical implications will be helpful on the ISS, medical informatics will be a necessity on any long-duration mission beyond Earth orbit. NASA has reached out to the best minds and most experienced people in the field (NASA, 1999) and continues to solicit their help. NASA is working with academia and industry in the form of Meditac, a commercial space center, to carry out applied research and to develop products, initially in telemedicine and, increasingly, in informatics. An example of the output of this collaboration was the development and testing in an analog environment (a 1996 Mt. Everest expedition) of lightweight core body temperature sensors. NASA has developed and tested numerous telemedicine technologies in low Earth orbit. These include the provision of an advanced cardiac life support system on Neurolab and STS-90 and the Telemedicine Instrumentation Pack (in conjunction with Meditac), which is a computer-based system that can videoimage the eye, ear, nose, throat, and skin and that may be used to monitor the electrocardiogram, systemic oxygen pressure, blood pressure, and heart rate.

Medical informatics can provide on board the spacecraft the information base that will underlie medical decision making during long-duration space missions. Telemedicine will provide the consultative link to Earth-bound systems of ground crews, flight surgeons, and consultants, albeit with inherent time delays. In a broader sense, medical informatics is a conceptual shift that views the physician not as an experience-based practitioner but as an information manager willing to use guidelines to provide care. Additionally, medical informatics will provide sophisticated techniques for the development of data-based guidelines for care and technologies for the storage, linkage, and rapid retrieval of information including that related to the new and rapidly advancing discipline of medical genomics.

Important for the entire crew of a long-duration space mission, but spe-

cifically for those responsible for medical care on board the spacecraft, is the capability for continuing education and updating of skills. For the medical professional on a long-duration mission, the degradations in unused knowledge and technical skills can be substantial. Medical informatics is thus necessary not only for knowledge and skills to be applied at a particular moment but also for continuing competence. Finally, since information will continue to develop while a long-duration mission is ongoing, there must be a mechanism for continued updating of onboard software and databases via linkage to the ground.

As stated earlier, the salient feature of a health care system for astronauts is comprehensiveness. In this context, comprehensiveness does not mean that every health care service is supplied at every site only by an individual employed full time within the system. Instead, it means that necessary and appropriate services be available. Because of the relatively small size of the astronaut corps, as well as the need for some degree of individual choice of practitioner by astronauts, this requires an extensive consultant and specialty capacity external to the primary system, as well as a means to attract, maintain, and promote clinical capability within the primary system.

There is, however, an additional consideration for space medicine consultation. That is the likelihood that the need for consultation by those on board the spacecraft will likely be sudden and urgent. NASA has traditionally relied on the telephone and electronic mail to contact its outside medical consultants; it recognizes that more real-time technologies must be used. Given the separation in time and space of the astronauts on a long-duration mission from their Earth-bound colleagues, a delay in urgent consultation would be detrimental. It will be important to incorporate continuing and future developments in medical informatics at all levels to ensure future success during travel beyond Earth orbit.

The committee’s perspective causes it to have concern about three issues related to the clinical capability within the primary health care system: the small n problem, the flight surgeon, and continuing competence.

Small n Problem The committee’s first concern is the small n problem (referring in this case to the relatively small numbers of individuals in the astro-

naut corps) and its effect on attracting good practitioners and maintaining their skills. NASA staff are well aware of this problem. Physically connecting the employee and the occupational health clinic at JSC with the astronaut clinic represents an attempt to address this problem.

Flight Surgeon The committee heard from a number of flight surgeons, all of who impressed the committee with their dedication to the space program. At the same time, their status within the program seems less than it should or could be. The committee believes, because of the evidence that it heard and reviewed, that the role of the flight surgeon as counselor and primary care physician is a key one. One of the most important reasons for this is the isolation experienced by the astronaut during space travel and the lack of privacy that demands the availability of a confidential channel of information. When the information is both sensitive for the individual and potentially critical for crew performance, a relationship of mutual trust and respect is necessary. The committee believes that it is important that NASA continue to examine ways to evaluate and upgrade the status and role of the flight surgeon, including ways to make the practice environment attractive.

Continuing Competence Medical professionals, especially physicians and nurses, put great store in continuing education to upgrade their knowledge and skills. In settings such as private practice and academia, there are multiple formal and informal structures and opportunities to interact with colleagues and to study. In the isolated setting in which most clinicians at NASA find themselves, few of these opportunities exist. Again, NASA staff recognize the problem. The committee encourages NASA space medical staff, in concert with those at the highest levels at NASA, to continue to seek approaches to provide ways for clinical staff, flight surgeons, and physician-astronauts to maintain and upgrade their knowledge and skills.

From the committee’s perspective, one way of approaching the issues of capability is this: medical professionals, especially physicians, enjoy diversity. The role of the flight surgeon is somewhat diverse, in that the individual serves both as the primary contact for the astronaut while the astronaut is on a mission and as a clinic physician. However, to enhance the role of the flight surgeon, to upgrade competences, and to maintain interest, all of which will increase the ability of NASA to attract good people, more needs to be done. The flight surgeon could be increasingly involved in the preflight train

ing of the crew, not only in relation to in-flight issues but also in relation to health promotion throughout the continuum of the premission, intramission, and postmission phases. Furthermore, since the health care system for astronauts must evolve over the next several decades, clinicians with management expertise may be attracted to the task of building such a system. Lastly, since the committee strongly recommends a clinical research strategy as the basis for ensuring the health and safety of the astronaut corps, flight surgeons may have a role in designing the research and its application. The model that the committee suggests is that of the academic physician, who is active in multiple components of health care, not only in the acute-care phase. By reconceptualizing the role of the flight surgeon to that of a substantial component of the space program team, the committee believes that the health of the astronauts will be enhanced.

Finally, current standards of practice and expectations by the medical community and the general public indicate that a physician should be part of the crew. Although in the analog environment of long-duration submarine missions no physician is generally included as part of the crew, the committee believes there are two distinctions that argue, at least initially, for a physician to be on board the spacecraft during a long-duration mission beyond Earth orbit. Unlike NASA, the U.S. Navy has had substantial experience with having a highly trained medical corpsman as the principal clinician on board a submarine. Furthermore, the time frame is distinctly different for travel beyond Earth orbit: telecommunication can be virtually instantaneous with a submarine, and when necessary, evacuation can and has taken place; that will not be the case in deep space.

The committee recommends that NASA establish a comprehensive health care system for astronauts that is integrated with other components of the space program and informed by the best knowledge base and information system available. Strong and sophisticated quality measurement and performance improvement methodologies are essential components of such a system. The science of quality measurement and performance improvement has improved greatly over the past decade as quality measurement and performance improvement methodologies have developed, as the public has grown to expect more from its health care system, and as medical professionals have grown to understand the value in objectively evaluating the outcomes of care. A report of the President’s Advisory Commission on Con-

sumer Protection and Quality in the Health Care Industry (1998), the Institute of Medicine publication To Err is Human: Building a Safer Health System (IOM, 2000), and related reports (IOM 2001a,b), as well as the public’s response to them, indicate that quality improvement in health care is imperative. The Institute of Medicine has been and continues to be at the forefront of public and professional activity in the field, for example, as sponsor of the National Roundtable on Health Care Quality (1996–1998) and the Quality of Health Care in America project (1998 and ongoing). NASA’s involvement in the latter and the National Quality Forum would enable NASA to obtain the best national and international advice from the field.

Advances in quality measurement include the following (IOM, 1999b):

• automated ways of reminding practitioners about the appropriate use of medications and the creation of a database about diseases and their treatments;

• the measurement of risk-adjusted mortality and investigation of the science and art of adjusting the measured outcomes of care, taking into account the severity of a patient’s illness and other risk factors such as the presence of other health conditions;

• measuring errors that occur in organizations so that organizations can pinpoint how such errors occur and how they can be prevented;

• the development of patient-reported measures of quality that allow organizations to compare a patient’s experience with the patient’s expectations;

• quality measurement in integrated delivery systems that include multiple settings of care; and

• the translation of well-developed clinical practice guidelines into performance measures.

These examples represent ways in which NASA might go about evaluating the results of a health care system for astronauts. Moreover, the use of state-of-the-art methodologies of quality measurement and performance improvement would make a significant statement that, when NASA is in fact ready to send humans deep into space, astronaut health and safety would be its top priority.

• Currently, there is no current comprehensive and inclusive strategy to provide optimum health care for astronauts on long-duration missions beyond Earth orbit, nor is there sufficient coordination of health care needs with the engineering aspects of such missions.

• An effective health care system is founded on data that are accumulated, analyzed, and used to continuously improve health care for astronauts on future space missions. Inherent in an appropriate health care system is a mechanism that can be used to gather and analyze data relevant to key variables. NASA could have collected and analyzed many more medical data had a comprehensive health care system focused on astronauts been in place and been given the priority and resources that it needed.

• Although the equipment and expertise that will be needed to provide health care during future long-duration missions beyond Earth orbit cannot be reliably predicted, a health care system that is data driven and linked to a research strategy will position NASA to better monitor pertinent developments and meet future challenges.

• care for current astronauts, astronauts who are in training, and former astronauts, as well as, where appropriate, their families;

• cover all premission, intramission, and postmission aspects of space travel;

• incorporate innovative technologies and practices—including clinical practice guidelines—into prevention, diagnosis, treatment, and rehabilitation, including provision for medical care during catastrophic events and their sequelae;

• be uniform across the international space community and cooperatively developed with the international space community; and

• receive external oversight and guidance from prominent experts in clinical medicine.