Internal Report Paints Bleak Picture of Human Life Science Research at NASA (part 2)

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Management.

As should be obvious by now, many of the problems described above are nested in management. Figures 10 and 11 speak volumes to the point. These charts read more like a plan for the invasion of Normandy than one outlining the steps, organizations, boards and individuals involved in the process for developing countermeasures (Fig. 10) and manifesting flight experiments (Fig 11). From the charts, the number of people involved are likely to be in the hundreds and the diagrams themselves are unreadable and unusable. Followed to the letter, these flow charts would inevitably lead to confusion. Another example is shown by Figure 12, describing the review board process experiments must pass through. The sheer number of paths almost screams that “no one wants to make a decision.” When astronauts’ lives are at stake, ethics and informed consent review is essential, of course, but at some point it becomes overkill. Take the case of alendronate again, a drug that has been in wide use for years with demonstrated benefit for osteoporosis and bone loss. Having gone through one of the strictest regulatory systems on the planet, the FDA’s approval process for consumer drugs, it must still be subjected to the twists and turns of Figures 10, 11 and 12 before it can be used in flight. By the time the Alendronate SMO gets through this gauntlet, no one will care because a list of bisphosphonates that could fill this page (and are already available) will likely have supplanted it on the ground, every one of which will have to follow in its wake. Absurdity number one is that one decent study on the pharmacokinetics of classes of drugs in microgravity might shortcut the process of requiring flight experiments for each individual drug by years, yet pharmacokinetics are called a Yellow 2 by the CPR and not even given top priority, a point of great contention to many Medical Operations personnel. Absurdity number two is that those same Med Ops personnel are able to prescribe drugs in orbit without knowing their pharmakokinetics. The system allows it to happen both ways, has a lag time of years with an incalculable waste and confusion factor. The underlying cause, in the author’s opinion, is a bureaucratic hodgepodge with NO CLEAR CHAIN OF COMMAND, and a management style operating by verbal rather than written orders, exasperated by an e-mail process that serves as the main organ of communication rather than formal memorandums. Everyone seems to have their hands in the decision-making pot, and duplication runs rampant. The consequence? From the Select for Flight Telecons to the review boards described above, action items are bounced back and forth between multiple codes, organizations and individuals with infrequent resolution.

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Typical of this “ping-pong” management” are the actions of one not-to be named review board emailing its members not to convene 48 weeks out of the year as opposed to informing them to convene 4. Memorandums of Understanding and Project Plans also abound—how SK should relate to SM written by SM; how SM should relate to SK written by SK; a plan to merge 2 major organizations after they were unmerged following a previous merger. While many of these plans never reach fruition, there’s a tendency to ignore them even when they do since it’s a safe bet they’ll be amended before anyone can get comfortable enough to implement them.

Another manifestation of poor management is the time between an experiments’ selection and its first flight. From limited data, the average waiting period for DSOs is 2.5 years, while that for ISS experiments is nearly 4 years, a delay that threatens the very foundation and utility of the experiment and tests the nerves of its PIs and flight managers alike. While extenuating circumstances such as schedule shifts, fleet turnaround times and accidents certainly contribute to delays, part of the blame must rest with management. Then there is the problem of conformance, ie., the number of crew members who actually sign up for an experiment after the crew briefing, shown for the DSO program in Figure 13.

On a typical shuttle flight of 7 crewpersons, the participation rate has averaged only 1.9 subjects or a 28% conformance rate since STS-95 (Chart B, Appendix 2). The track record on ISS seems better, averaging nearly 50%, but that is deceptive since only 3 crewmen fly and 1.4 sign up. Poor conformance starts with the crew briefing, the presentation given to each ISS or STS crewmember by the Principal Investigators. Often referred to as Informed Consent Briefing or ICB, the crew briefing is where informed consent agreements and confidentiality agreements are obtained and BDC (biological data collection) schedules are baselined. Despite the fact that crew participation is essential to the success of the flight research program, the program is strictly voluntary and PIs must compete against each other for astronaut’s services. Allowing for the fact that subjects can be disqualified on medical grounds or excluded from some experiments because they’re mutually exclusive of others, the potential subject pool is lowered before it even starts. Then comes the crew time barrier. With less than 20 hours/week available for research (Figure 14), conformance is crippled again as it leaves from the starting gate. Next comes R+0, the 4 hour time limit for landing day data collection, and the beat goes on.

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Med Ops Medical Operations are distinct from flight research management yet so interwoven with it that they must be treated separately. Charts as convoluted as Figures 10-12 would be needed to show all the interactions (one has yet to be written, the challenge is so great). Although the primary goal of Med Ops is to maintain crew health and well-being during all phases of flight, they have many other responsibilities including:

• Medical Requirements Documents (MRIDS)
• Crewmember medical selection and certification
• Biomedical training on medical systems, procedures, and protocols
• Pre-, in-, and post flight health evaluation and monitoring
• Delivery of prevention, diagnostic and therapeutic care
• Environmental health and monitoring
• Crew countermeasure implementation
• Emergency medical services
• Crewmember rehabilitation and fitness evaluations

Though unintended, many of these responsibilities undercut the research program. The following examples illustrate the point :

• R+0: There is a 4 hour time limit on landing day (R+0) to collect biomedical research data. Of this, US Med Ops personnel has custody of more than half (2.25 hrs on average), taking 1 hour alone for the standard post flight medical exam. This leaves only 1.25 hours for science at the most crucial time of data collection. R+0 is where the rubber meets the road, the closest point of comparison between pre-flight 1 G data and the still-fresh effects of microgravity upon immediate return. Despite its importance, data collection must be compressed into a little over an hour. The process of doing so is a scheduling nightmare, since all manifested experiments are competing against each other for time within that window. It taxes the PIs and BDC team to the limit every flight.
• Data-sharing: Astronaut privacy concerns scuttle the possibility of ready data transfer between PIs. Such data exchange is needed to reduce the effect of confounding variables. Even without these concerns, there is no commonality of equipment on orbit or on the ground, no attempt to work together to maximize science or reduce costs and time through sharing.
• The exercise protocol under the auspices of Med-ops is not tightly controlled. Although the ASCRS work hard to generate individual exercise prescriptions, conformance is left up to the crew and varies widely.
• Drugs are available and dispensed that can and will alter the effects of flight research studies. The list of available medications reads like an on-board pharmacy and the paper trail linking them to subjects participating in flight research experiments is not always well documented.
• Medical Operations for Russian Cosmonauts are treated differently than US Med-ops for astronauts. These differences, as will be seen below, contribute to more inconsistencies.

Our Russian Friends

Although this too falls under the purview of management, it is so unique, that it must, like Med Ops, be addressed separately. The Russians (and ESA) have their own Biomedical Researach Program, which, at first blush, is supposed to complement our own. But does it? Figure 15 lists Russian human flight experiments on ISS alongside some of their US counterparts. Many of these experiments appear to mirror our own with the whole being less than the sum of its parts. Cases in point: Russians don’t pay attention to the CPR and are doing experiments in several disciplines that may be duplicative; Russian crewmembers can participate in US experiments if we pay them, while American astronauts cannot participate in Russian experiments; some US PIs arrogantly think of Russian experiments as “tissue paper” (Fitts, for example, who, it must be noted, has the largest cost per year of ANY experiment on the manifest, and has an N of 3); Russians are not invited or choose not to attend the ISLSWG meetings that select experiments from NASA NRAs, choosing their own peer review process for their experiments in a way some NASA overseers view as inferior; the same precious space aboard ISS may be occupied by Russian hardware virtually identical to our own (the Russian experiment, Profilaktika uses a bicycle ergometer (velometer) while the CEVIS is available as well); Russians view the program with different priorities, choosing thermoregulation, (the experiment, Thermography) as a high priority while the US CPR ignores it, and so on. Life at ESA isn’t much different. In the past month alone, 3 flight experiments suddenly appeared with requests for manifesting, one for blood pressure monitoring, another for EKG analysis (Rhythms) and a third for neurovestibular assessment (NeuroCOG), all remarkably similar to current DSO or HRF experiments. How many ways can one split the hairs of an EKG, one might ask, and how many varieties of 3-D visual imagery can one look at in the “name of science” without a countermeasure appearing? In a program with such limited resources, there shouldn’t be many but there are. We may have a joint international crew but we do not have a joint research program. The expression, “A house divided against itself cannot stand,” comes to mind.

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Summary

There are many excuses some would cite for the poor performance described above: it’s a vestige of the old days when operations led the food chain; the system is changing and it takes time to mature; ISS is in the build phase and research must await its completion; a flight platform is not a ground platform and one must live with confounding variables; a 3 person crew can’t perform like one with 6; STS 107 effected the schedule, and so on. While many of these excuses are valid, three facts stand out. The average experiment takes 5-6 years to complete, can cost as much as $4M and the avowed expectation of 3 experiments to flush out a single countermeasure in a particular discipline is pie in the sky. The more likely scenario, under the best of circumstances, is that when ISS has reached the end of its useful life, the number of countermeasures so derived will be pitifully small compared to the investment. Under the worst of circumstances, ISS will be in the ocean without a single red 1 countermeasure in the books for the cardiovascular, neurovestibular, pharmacokinetics, behaviour and other major disciplines. Then again, we could get lucky.

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CPR

This tool needs to be drastically overhauled to reflect the realities of the ISS and Shuttle flight platforms. Multiple experiments from the same discipline with confounding variables and poor controls is not the way to harvest productive countermeasures. Currently, the CPR drives the NRA but without a flight NRA, its usefulness would be confined to the ground NRA. One possibility is to merge it with an evidence-based space medicine office. Such an office, under the direction of Dr Jonathon Clark with input from Dr John Charles and the NSBRI, for example, would effectively integrate the CPR into a responsive and robust organization whose job would be to strike a compromise between the old CPR goals, actual flight observations and programmatic priorities. This office would solicit input from the NSBRI and other investigators to shape the content of the ground NRAs. The NRAs would then focus on identified operational constraints instead of traditional physiological disciplines. Such an arrangement would place the human as a subsystem in the flight operations program rather than as a unique exception to it. It would place the physiological alterations related to space-flight in the context of their operational implications. For example, postflight egress has been regarded as a significant operational problem after long-duration spaceflight. Inability to egress is caused by disturbances in sensorimotor, cardiovascular and muscular function. A multi-disciplinary team could address the various components underlying egress capability in a more integrated fashion than does the current system. This concept could carry over to other operational issues such as landing performance, EVA etc. This operational team approach would focus the research questions and foster inter-disciplinary interaction. It is only through such interdisciplinary interaction that we will be able to develop integrated countermeasures that address changes in multiple physiological systems

PROGRAM MANAGEMENT

Aside from the NRA and CPR, a majority of the barriers to an effective and efficient flight research program come from management insufficiencies. These insufficiencies reside in many areas, subtle as well as obvious, and only the most obvious will be discussed here with some possible solutions. They are: confounding variables, data sharing, the crew briefing, R+0, the Russian problem, medical operations, payload operations and flight manifesting.

Confounding Variables

Under the best of circumstances, even with a revised NRA, CPR and relevant experiments in the pipeline, the usefulness of the flight program would still be highly suspect due to low N’s and confounding variables. As stated at the onset, the “we have to live with it, that’s the nature of the beast,” mantra has become endemic and part of the culture. It must be eliminated and science must be taken seriously. More seriously than the handing out of grants to familiar institutions; more seriously than randomly filling in manifesting slots; more seriously than chaotically dispersing unobligated funding lines and more seriously than implementation concerns of schedule, up-mass, volume and a dozen or more other chokepoints from R+0 to ceremonies at the runway to overly time consuming physical exams. The first place to start is by devariable-izing the mix. If exercise effects bone loss, it must be removed as a factor in drug or vibration studies looking at bone loss; if uncontrolled exercise prescriptions effect studies of muscle strength, aerobic capacity, endurance and thermoregulation, participating subjects must have tightly controlled protocols; if electrolyte balance and weight loss effects cardiac function, both must be eliminated as variables in cardiovascular studies and so on. Not all experiments are susceptible to confounding variables in the same way, however, and it is useful to list the degree of susceptibility. Discussions with various investigators, internal and external, led to the “proneness” index for each discipline and “confounders” list shown in Figure 23.

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Data-sharing

Data sharing is like an appendix, a vestigial organ left over from NASA’s cave man days. Astronauts are supposed to be subsystems in today’s NASA, but like it or not, they still stand atop the food chain and their privacy rules are like the bible. Example: a PIs request for an ISS crewmember’s body weight was denied on the basis of it being privileged medical data, thereby preventing him from understanding the effect of body mass on impact load, the very purpose of his experiment. Body weight? The same body weight on everyone’s driving license and passport? Privacy restrictions abound, they’re icebergs confronting the Titanic, sabotaging any hope of eliminating confounding effects. How can PIs hope to work together when the system won’t let them? The recommendation: Remove censorship from the purview of medical operations. An independent board with research science and crew presence should make all data-sharing decisions and the onus should be on proving why data shouldn’t be shared, not why it should.

Even if data sharing ceases to be a barrier to confounding variables, the idea of PIs sharing information is still an alien concept. Aside from that, the system still discourages sharing because experiments with similar objectives are rarely manifested together. Taken together with the vagaries of the CPR, which cause overlapping experiments addressing many of the same Critical Risks and Critical Questions, the inevitable results; exorbitant costs and duplicative science.

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The Crew Briefing

Given the importance of the crew briefing as a choke point (discussed earlier), steps should be taken here to insure maximum conformance. One recommendation is to designate an Experiment Coordinator (EC) from the Astronaut Office to bridge the gap between the flight crew and the PIs. The EC, preferably with a medical or research background, could deliver a pre-briefing prior to the actual ICB, preparing the crew beforehand for the formal PI presentations. This would foster more relevant information exchange than the current format, which compels the Principal Investigators to compete against one another in “selling” their individual experiments within 15 minutes. Other recommendations regarding the ICB:

• Mission or Increment Scientist leads discussion
• Introductory remarks kept to a minimum (5 minutes or less)
• 10 minute maximum per PI presentation
• 10 viewgraph limit per PI presentation
• What, why, when and where format
• Show how experiment will benefit the crew and the public at large
• List crew constraints of each experiment (food, drugs, motion, invasive procedures, etc)
• Show number of subjects required to complete an experiment
• Show number of subjects completed to date for each experiment
• PIs or designated Co-Is must be required to attend the ICB
• No discussion of rank order prioritization
• Controlled attendance limited to presenters, PIs, flight surgeon and need to know individuals
• Formalized Debriefing required within 12 months of crew return

The Russian Problem

As previously elucidated, data collection and sharing are not equal and bi-directional with the Russians, despite bi-lateral agreements to the contrary,. This issue is part of a much larger and more serious one–flight experiment non-cooperation. The consequence of this disconnect is a redundant, wasteful and illogical imbalance in the flight program. One reason for this is a lack of consensus among NASA’s international partners on the content and appropriateness of our NRAs, CPR and MRIDs/CSEs (Medical Requirements Documents/Clinical Status Evaluation–the collection of pre/post measurements used by Med Ops personnel to assess the physical well-being of returning crewmembers). The Russians do not feel compelled to participate in many of these processes for a variety of reasons. Among others– they feel NASA is biased because it insists on more stringent limits on astronaut crew time than that of their cosmonauts; they claim some US PIs believe Russian data collection is inferior; they feel that differences in financial compensation justify Russian crewmembers being paid to participate in US experiments. The solution to such opposing points of view is difficult, especially since there is a cultural component. It will require trust, policy change and true bi-laterality. It will also take time and the familiarity it breeds, which may be the saving grace. The recently completed Increment 6 mission where the crew landed hundreds of kilometers away from their target in the steppes in Russia is a hopeful sign of progress. Despite the difficulties of shipping equipment through customs, getting Russian participation on many bureaucratic fronts and integrating a complex program of data collection and joint operations, it went extremely well. Perhaps in the end, the workers in the trenches will solve this problem on their own.

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MANAGEMENT

Conceiving and implementing management changes six to ten years from now is like looking in a crystal ball. Having said that, certain trends have been noted throughout this document and bear repeating. Ignoring for the moment that program priorities could totally change, the far term approach of cost scrutiny should still be appropriate. The emphasis then must be on efficiency and effectiveness across the board. This includes:

• An Experiment Commonality Board to insure manifesting of experiments utilizing common parameters and common hardware on the same missions
• A Data-sharing board with research science and crew presence to oversee data-sharing issues and prove why data shouldn’t be shared, not why it should.
• An evidence-based space medicine office to strike a compromise between the current CPR and actual flight observations
• A reorganization that places the astronaut as a subsystem in the flight science program rather than as the lynchpin of it. This new organization would insure high conformance rates and emphasize cross-disciplinary physiological alterations within the context of operational implications. Postlflight egress problems following long-duration microgravity exposure is a good example, implicating the sensorimotor, cardiovascular and muscular systems. A multi-disciplinary team could address the various components underlying egress capability in a more integrated fashion than currently exists. The concept would carry over to all other operational issues such as landing performance, EVA etc. This operational team approach would focus the research questions and foster inter-disciplinary interaction. Integrated countermeasures that address changes in multiple physiological systems can only evolve through such interactions.
• Implementing the 5×5 charts in Appendix 1 to better determine science and countermeasure value for each experiment.
• Other changes as noted to Med-Ops, R+0, the Russian Relationship and Payloads

In summary, the ping-pong management style that exists at the present time is unacceptable. The focus for the long term should be fundamental management change and these changes should begin at once. Such changes will not be easy. On the investigators’ side, they may require PIs to assemble in a team approach; sacrifice benefits to their home institution; sacrifice some intellectual property; share data, publications, and so on. Space and Life Sciences has an equal dilemma. How can an organization that has doled out so many dollars to so many contractors and academic institutions for so long hope to combine them in an efficient way? The answer may come from the Operations side of the house. United Space Alliance is the sole primary manager for Shuttle operations today, as opposed to the multiple contractors of the past, and ISS is still airborne. In the wake of STS-107, however, the jury is still out.

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CONCLUSIONS

An attempt has been made to list the shortcomings of the current human life sciences flight research program for ISS and Shuttle, with recommendations to mitigate these shortcomings. The approach divided the recommendations into near, mid and far term solutions, ranging from the specific and pragmatic MTA approach (easy to do) to more painful and complex management overhauls (hard to do). The dire consequences of ignoring the problems described in this report cannot be understated. One has only look as far as well written and accurate May 24 article in the Houston Chronicle to see how precarious the situation is. The human flight research program is supposed to be at the pinnacle of the International Space Station, yet it is subjugated to constraints that conspire to overwhelm it. NASA’s founding fathers would turn in their proverbial graves at the sight of such a convoluted organization. Has it become just another organizational bureaucracy whose sole purpose is to dole out taxpayer dollars to contractors and old boys networks in the hypothetical name of science with “not a lot of substance,” as the article contests? If the answer is yes, make ISS and Shuttle the centerpoint of some other goal such as a human Mars mission, for which it could be an operational, not a research oriented test-bed. The issue is clear. Voodoo science is not worth the cost. The limb of the fault tree Life Sciences is perched upon is perilously close to breaking.