The Year in Veterans Affairs & Military Medicine 2014-2015 Edition

C e l e br at i ng t h e 6 0t h A n n i v e r sa ry of Vet e r a ns Day

THE YEAR IN

Veterans Affairs

& Military Medicine

2014-2015 Edition

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THE YEAR IN

2014-2015 Edition

Veterans Affairs

& Military Medicine

U.S. Army Photo by Spc. Lance Philpot

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Contents

■■ Special Section: VHA Office of Research and Development • Interview: Dr. Timothy O’Leary Chief Research and Development Officer, Veterans Health Administration, U.S. Department of Veterans Affairs ..................

By Craig Collins

10

•V A Research: Post-deployment Health......................... 24

By Craig Collins

• V A Research: Cancer ....................................................... 30

By Craig Collins

• V A Research: Spinal Cord Injury.................................. 34

By Craig Collins

• V A Research: Diabetes .................................................... 40

By Craig Collins

■■ The History of Veterans Day ........................................ 46

By Dwight Jon Zimmerman

■■ Opening Doors to Better Health Care VHA’s Office of Quality, Safety and Value

By Dr. Robin Hemphill

............................... 54

■■ Blood: The Greatest Gift of the Greatest Generation

During World War II, plasma saved lives. ..................................60

By Anastasia Kirby Lundquist

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Contents

■■ Air Force Dental Service

A History of High-flying Dental Care ........................................66

By Dwight Jon Zimmerman

■■ Pay, Benefits, Budgets, and Reform............................72

By J.R. Wilson

■■ Face and Hand Transplant Advances.........................82

By Gail Gourley

■■ Health Care-acquired Infections:

A New Threat Emergent

Clostridium difficile is now public enemy No. 1 in the fight against HAIs.................................................88

By Craig Collins

■■ Post-traumatic Stress Disorder and

Traumatic Brain Injury ................................................94

By J.R. Wilson

■■ Better Treatments, Better Outcomes for Veterans

with Hepatitis C

VA is on the leading edge of Hepatitis C care. ..........................100

By Craig Collins

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THE YEAR IN

2014-2015 Edition

Veterans Affairs

& Military Medicine Published by Faircount Media Group 701 North West Shore Blvd.

Tampa, FL 33609 Tel: 813.639.1900 www.defensemedianetwork.com www.faircount.com EDITORIAL Editor in Chief: Chuck Oldham Managing Editor: Ana E. Lopez Editor: Rhonda Carpenter Contributing Writers: Craig Collins, Gail Gourley, Dr. Robin Hemphill, Anastasia Kirby Lundquist, J.R. Wilson, Dwight Jon Zimmerman DESIGN AND PRODUCTION Art Director: Robin K. McDowall Designers: Daniel Mrgan, Kenia Y. Perez-Ayala Ad Traffic Manager: Rebecca Laborde ADVERTISING Ad Sales Manager: Ken Meyer Account Executives: Jim Huston, Jared Crews, Jim Pidcock, Geoffrey Weiss OPERATIONS AND ADMINISTRATION Chief Operating Officer: Lawrence Roberts VP, Business Development: Robin Jobson Business Development: Damion Harte Financial Controller: Robert John Thorne Chief Information Officer: John Madden Business Analytics Manager: Colin Davidson Events Manager: Jim Huston

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The Year in Veterans affairs & military medicine

Interview

Dr. Timothy O‘Leary Chief Research and Development Officer, Veterans Health Administration, U.S. Department of Veterans Affairs

Timothy O’Leary, M.D., Ph.D., the Chief Research and Development Officer (CRADO) for the Veterans Health Administration (VHA), U.S. Department of Veterans Affairs (VA), oversees a research program conducted at more than 100 VA medical centers around the nation that addresses a full range of health concerns affecting America’s veterans. The research program dates to 1925 and includes biomedical, clinical, rehabilitation, and health services research. Its investigators have earned three Nobel prizes, seven Lasker Awards, and numerous other national and international honors.

O’Leary’s career began during his undergraduate studies at Purdue University, where he majored in chemistry. He went on to earn a doctorate in physical chemistry from Stanford University and a medical degree from the University of Michigan. He conducted research for the National Institutes of Health (NIH) and the Food and Drug Administration before joining the faculty at the Armed Forces Institute of Pathology (AFIP), where he chaired the Department of Cellular Pathology for more than 15 years.

O’Leary joined the VA in 2004, initially as director of Biomedical Laboratory Research and Development (BLR&D),

10

then director of BLR&D and Clinical Services Research and Development (CSR&D). In June 2014, he was named CRADO for VHA. His research interests include genomics, proteomics, and ultrasensitive detection of biological toxins. He has served on numerous federal panels and advisory committees, including the Health and Human Services Clinical Laboratory Improvement Advisory Committee and the Food and Drug Administration Hematology and Devices Panel. He is a past president of the Association for Molecular Pathology, and serves as editor-in-chief for its Journal of Molecular Diagnostics.

For 31 years, while he lived and worked in the Washington, D.C., area, O’Leary served as a reserve member of the Public Health Service Commissioned Corps, serving two tours on active duty. “My father was a career Army and Air Force officer from 1946-68,” said O’Leary, “and his father served in the Army during World War I, so I grew up military. The soldiers, sailors, and airmen I served with at AFIP represented the finest that the United States people have to offer, so continuing to focus on this population is as natural as eating or sleeping.”

www.defensemedianetwork.com

U.S. Department of Veterans Affairs photo

By Craig Collins

The Year in Veterans affairs & military medicine

Craig Collins: You joined the VA in 2004, not long after the launch of Operation Iraqi Freedom – and it’s been a decade of enormous changes for the VA and its research program. Could you describe some of those changes?

U.S. Army photo by Melissa Miller

Dr. Timothy O’Leary: I think that’s true. First of all, there’s an awful lot that remains to be done. There’s a lot we don’t know. For example, we can help people with PTSD [post-traumatic stress disorder] and TBI [traumatic brain injury], but we’re a long way from a cure. I’d like to think of our research as having the objective of amending the words of Abraham Lincoln that are inscribed on a plaque at our VA headquarters: “To care for him who shall have borne the battle and for his widow, and for his orphan.” Our real objective is to cure those who have borne the battle. And we’re not there yet.

First and foremost – because we’re a small program, and because research is expensive – it was important that we develop strong relationships with other federal research organizations, and particularly the Department of Defense [DOD] Health Program. We see the same people at different points in their lives – they get them first; we get them afterward, but sometimes they go back on active duty after we’ve seen them – so we’ve tried to coordinate our programs more effectively. Terry

■■ “As long as the United States plays a leadership role in the world, our uniformed men and women are going to be placed in harm’s way. And we need to be looking forward.”

www.defensemedianetwork.com

■■ Army Col. Dallas Hack, director of the U.S. Army’s Combat Casualty Care Research Program, right, and Dr. Terry Rauch, director of the Defense Medical Research and Development Program, left, discuss veterans’ mental health and traumatic brain injury research and care issues during the Military Health System Research Symposium in Fort Lauderdale, Florida, Aug. 14, 2013. VA research has developed strong relationships with other federal research organizations.

Rauch, the director of the Defense Medical Research and Development Program, invited me to participate in reviews of their program. And one of us or another – I’m not sure who gets the credit or the blame – suggested that we really ought to make these joint program reviews. So we rapidly changed to where we reviewed the Defense Health research and VA research together, so that we know we’re covering ground more effectively together.

We already had some level of involvement with the National Institutes of Mental Health, in particular the National Institute of Neurological Diseases and Stroke, in their program reviews. But as a result of the executive order that President [Barack] Obama signed about a year ago on psychological health and traumatic brain injury, they became full partners. So now all four research programs – or all three, if you think of NIH as one organization

– are reviewed and coordinated together, to assure that we maximize the impact of federal law and spending to benefit those people who put on a uniform to defend their country. So that’s one of the huge changes, I think.

We also adopted the use of NIH’s Electronic Research Administration system, eRA, to assist in program review. In the course of doing that, we’ve gained access to full information about those things NIH is funding, and they’ve got full information about what we’re funding. We can access not only their knowledge, but their ability to coordinate research from a management perspective. So that collaboration is another huge change.

We’ve also engaged in two programs aimed in part at changing the way research is done. One is the Million Veteran Program [MVP], which was a change for VA towards doing Big Science. For the most part, with the 11

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The Year in Veterans affairs & military medicine

U.S. Department of Veterans Affairs photo

■■ Rich Bartels has blood drawn by LeAnne Pomeroy, a Million Veteran Program ( MVP) research assistant, as part of volunteering to be an MVP participant.

exception of a few large clinical trials that we run every year, most of the research done in VA was done, and is done, in individual research laboratories scattered around the country but not tightly coordinated with each other.

MVP is an attempt to bring a more massive collaboration together that enables us to achieve economies of scale, while still harnessing the phenomenal intellects and skill sets of VA researchers around the country.

A second change in the way VA research is done is point-of-care research, which is an attempt to take large clinical trials, particularly those that are comparing two well-accepted health care interventions: things that might both be standard of care, but

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may not be quite equal. Point-of-care research allows us to compare these interventions in a prospective, randomized fashion as they are used in the clinic. This will potentially give us the opportunity to run very large clinical trials that are capable of detecting somewhat small differences in reasonable time and at a reasonable cost.

Now, why might that be important? Say we’re treating somebody for depression. Well, maybe one antidepressant is 5 percent better than another. A traditional randomized control trial can’t be big enough, at finite cost, to detect that small a difference. But 5 percent is a big deal if you’re one of those 5 percent who gets an immediate response.

And it can have a tremendous impact

down the road. So being able to identify things that are just slightly better at a reasonable cost has, in a health care system that takes care of six million people, a tremendous effect.

Maybe 10,000 individuals might be effectively treated who weren’t treated effectively before.

We’re planning to launch a large point-of-care study over many sites comparing two diuretics used for the treatment of hypertension. One of them, chlorthalidone, has been used in most of the trials looking at the effectiveness of treating hypertension using diuretics. But the other, hydrochlorothiazide, is actually prescribed about 10 to 20 times as often, both inside and outside the 13

The Year in Veterans affairs & military medicine

VA, as chlorthalidone. It’s thought by many to be equivalent, but some of the hypertension experts think that maybe chlorthalidone will be better, because it has a longer half-life and so it should, they think, maintain and keep blood pressure from spiking so much over the course of a 24-hour day. The only way to know this, again, is through a clinical trial, and a clinical trial of this sort would be prohibitively expensive if done in the traditional way. But we believe this pointof-care randomization approach will make it possible for us to do this trial and do it at a more affordable cost.

Now that the wars in Iraq and Afghanistan appear to be winding down and service members are redeploying, do you think the close working relationship between VA and DOD research programs will continue?

Those collaborations aren’t going to go away. I think there are a couple of reasons for that: One, the collaboration is the right thing to do. Two, the personal relationships are good. Terry Rauch and I can finish each other’s sentences, we’re so much alike. Also, our research isn’t something that necessarily immediately benefits the soldiers, sailors, airmen, and Marines serving today. Many things that we do will take five or 10 or 15 years to truly pay off. As long as the United States plays a leadership role in the world, our uniformed men and women are going to be placed in harm’s way. And we need to be looking forward.

How do you think VA research will position itself to anticipate what lies ahead for service members? That seems really difficult.

Some things will be difficult. But some things we can predict. We know from looking at the history of warfare that what we call post-traumatic stress disorder now, and what we call traumatic brain injury now, are things 14

that have been going on for a very long time. We as human beings are not changing our physiology very quickly, and there’s nothing about the nature of warfare that’s going to make those issues go away.

One of the huge differences about warfare today, which I think we can prepare for to some degree, is the fact that now people are surviving injuries that would have been lethal in previous conflicts, which makes it much more important that we be aggressive in developing assistive devices and technologies of all sorts, such as tissue engineering, to try to ultimately be able to replace missing body parts. It’s important that we be looking forward to how to make whole those people who have survived – but survived with much more severe, chronic injuries than people would have dealt with in previous conflicts. That survivability is going to continue to go up. Our colleagues in DOD who do emergency surgery and emergency medicine are getting better all the time. And there is no doubt they’re going to be getting better, that we’ll be seeing more folks who survive more and more serious injuries. And we can anticipate that and work on it today.

It’s lovely when a research study that we do today benefits somebody who’s with us today. But those are not the only people who are called to serve, and our job is to look forward. I believe that the job of research is to help invent the future of health care.

What are some of your other goals for VA research – things you’d like to see happen while you’re in charge?

We’re dealing with a lot of challenges.

One is that obviously research is fairly expensive – because of changes in technology, the cost of doing research tends to increase faster than the cost of living as a whole. In addition, the cost of conducting clinical trials, because of a desire to do a superb job of humansubject protection – and the regulatory burdens that go along with that,

as well as scientific standards for doing clinical trials – all those things have increased the cost of doing clinical trials, at a rate that appears to be faster than the rate of increase of health care costs as a whole. This poses a challenge in a fiscally constrained environment. And that’s obviously some of the reason behind trying to transform the methods by which we do research, but that ultimately only takes us part of the way we need to go.

The second set of challenges, which also has a financial implication, is that the range of problems that we deal with in the Veterans Health Administration is very, very wide. And veterans who suffer these problems would like to see us engaged in research for two reasons. One is they believe that research may benefit them personally, or benefit those that suffer from similar problems coming in the future. Second, having clinicians in the health care system engaged in research assures that VHA is able to bring top-quality health care to the veterans these clinicians serve.

That research-engaged physician is absolutely compelled, not just because of clinical care, but also because of his or her research interest, to keep up with the literature and change with the times.

Part of the genius in linking VA health care with the academic medical system, an idea that first occurred back in Gen. Omar Bradley’s time, is that it brings academic physicians into VA health care. In Boston, for example, many of the people treating our veterans also carry titles like professor of medicine, Harvard University. They’re pretty top-rate people.

At the same time, obviously, there’s sometimes a crunch in health care access for veterans. Health care needs are immediate, and research is seen as having a future payoff. So there can be a tendency to say: ‘Well, we’ll put off the research and see our patients now.’

For a short period of time, this is perfectly appropriate and reasonable. But over a long period of time, if this continues, it’s like eating your seed corn.

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The Year in Veterans affairs & military medicine

You have a problem with next year’s harvest. And so having a health care system embedded in a deeply political environment, I think, creates challenges, because the political system is not always as strong in thinking about the future as it is in dealing with the present. And we all know that of late we have been practicing government by crisis management in many ways. I think this is a concern for missions not only in VA but in our research partners as well.

PTSD and TBI are often called the “signature wounds” of the conflicts in Iraq and Afghanistan. But there seem to be other health problems that are more prevalent among

16

veterans than among Americans as a whole – diabetes, for example, and hepatitis C. Are there other health challenges that are more particular to veterans? Do these disparities affect the apportionment of resources in VA research?

Diabetes, of course, predisposes to other health problems, one of which is cardiovascular disease. And in the VHA, we take care of a population that is somewhat older than the population as a whole, and as you get older, your risk of developing cardiovascular disease and stroke goes up. So we do take care of more people who are suffering from these vascular diseases than the population as a whole.

Another thing that happens is that smoking has been increasing among

veterans who have come back from Iraq and Afghanistan – smoking rates that are maybe twice what we see in the population of the United States as a whole. And of course, that’s associated with lots of things. It’s probably associated with certain mental health conditions. It’s certainly associated with the development of cardiovascular and pulmonary disease. And as you know, we have concerns about pulmonary health in people that have participated in this conflict, either because of dust in the atmosphere or burn pits. If we bring that together with smoking, this is clearly an important area for us to move forward on.

So we need to continue with a strong research program associated with cardiovascular disease, which may also

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U.S. Air Force photo by Joe Juarez

■■ Retired U.S. Air Force Master Sgt. Alfredo Alferez, left, undergoes a screening for diabetes, provided by the 61st Medical Group, at the annual Retiree Expo in the Gordon Conference Center, Los Angeles Air Force Base, California, June 26, 2010. The VA cares for a greater proportion of veterans suffering from diabetes than in the population as a whole.

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The Year in Veterans affairs & military medicine

be increased in people with PTSD. There is evidence that mortality rates among people who suffer from PTSD are higher than those that suffer in the general population – cardiovascular mortality is probably a piece of that.

We struggle to find a balance between treating what you think of as general health conditions, like cardiovascular disease and stroke, for which the peculiarities of military service, such as taking up smoking or PTSD, exacerbate the risks.

To some degree, the investigatorinitiated components of our research program actually help us to achieve this balance. As with NIH, much of our research – not all of it, but much of it – begins with an investigator, usually a clinician investigator who sees a problem they deal with in their clinical practice and makes a proposal for funding to us. And they have the opportunity to evaluate that in terms of scientific merit. But part of that merit evaluation is an assessment of the scope of the issue for the population as a whole, and VA in particular. So if our clinical care system is dealing with a tremendous amount of issues associated with mental health, as it has over the last few years, the number of mental health professionals and mental health investigators will go up – and even without much intervention on our part, the tendency will then be to shift resources to where those applications are coming from, because that’s an indicator of a real set of issues within our health care system. We hope we get a balance in the course of doing it.

We have analyzed this and we find that, aside from a few things, as a whole our recent portfolio actually tracks our health care expenditures pretty well – with the exception that we spend more on things like PTSD and polytrauma and military occupational exposures than you would expect from their prevalence in VA health care. And that seems to be the right thing to do. So I think we’re in a good place. But there is no magic formula, and there are certainly going to

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■■ “I think the commitment the VA and VA research have to optimizing the health care system through the use of good science is unique, because we don’t optimize that health care system to make money.

We optimize the health care system to optimize health outcomes.”

be those who think we should have a somewhat different balance.

VA research seems to have been involved in several historic milestones in the past year alone – for example, the evaluation at the James J. Peters VA Medical Center, Bronx, New York, of the robotic ReWalk™ exoskeleton, which is now commercially available, has shown that paraplegics can stand and walk again. Researchers at the Miami VA Medical Center demonstrated that an artificial pancreas, developed in Israel, can be implanted in human subjects without being rejected. Are there other advances, either being developed through the VA research program or in partnership with other researchers, that we’re going to look back on as game-changers in 20 to 30 years?

That artificial pancreas was interesting; while that was not a VA product,

it built on a lot of work by VA researchers who were looking at how glucagon and insulin work together to regulate blood sugar. In the past, we’ve tried to regulate insulin alone. More recently, at least one of the bio-artificial pancreas designs uses both insulin and glucagon in a feedback loop. And that work really is very much built upon work in which the VA investigators were pioneers.

I think tissue regeneration, and some of the work going on in spinal cord injury, for example – is suggesting that certainly animals, and hopefully someday people, who have had longstanding injuries may be able to get partial restoration of spinal cord function.

I think that’s a true game-changer. I mean, until now, the idea has been that if somebody was paralyzed through a spinal cord injury, it was for life.

In fact, the work in tissue regeneration as a whole is a game-changer.

Imagine that for somebody who has had a liver destroyed – because they had the misfortune of ingesting a toxin, for example; it’s not just about alcohol and hepatitis – you might be able to regenerate their liver and transplant it back into them. Or that we might be able to take a kidney from a pig, humanize it, and transplant it into somebody and take them off dialysis. I think these kinds of bioartificial approaches are going to be very, very important.

In information science and connected health, we are moving from a world of Internet-connected computers to a network of cell phones and computers – and ultimately to a network that includes information from devices such as thermostats and meters. I think we’re going to be connected to that Internet. To some degree, we are now; information technology allows us to perform point-of-care research.

You may have a pacemaker that allows you to examine what’s going on from a distance, or a device that helps you remember to take your medications.

But I believe that the use of information science to help monitor our health and help us change our habits ourselves is going to be very, very important. The 19

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The Year in Veterans affairs & military medicine

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■■ Biomedical engineer Jenni Popp with the National Institute of Standards and Technology’s prototype bioreactor for tissue engineering. The bioreactor both stimulates and evaluates engineered tissue as it grows. Tissue regeneration and bioartificial techniques hold great promise for future patients.

idea that an Internet-enabled refrigerator or cell phone app may be able to tell me: “Tim, you’re coming up on your 2,200 calorie limit today – you’ll want to maybe stop eating.” I think information science and connected health can make lives easier, as we grow older, so that people spend less time in nursing homes and more time in their own homes.

And finally, I think genomics is going to continue to expand and to change everything. I think it’s a fair statement that a very high fraction of new cancer treatments are coming as a result of understanding cancer genetics. I think that’s going to move more and more out of the realm of cancer – it’s going

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to move into mental health, into general internal medicine. And then when you bring that back together again with informatics solutions – because there is so much known, but none of us can know it all; I can’t look at a 3,000or 3 million-base pair sequence and make heads or tails of it by myself. But the computer can do that. It can tell me what to do about it. And it will help us deliver better medical care … It will probably say something like, “Based on what we know about this patient and their genetic material, the treatment for the condition is drug action at the rate of Y milligrams, given three times a day with meals.” And I think that’s going to be truly amazing. We’re

going to play a big role in that, because of the importance of informatics in our research program, but also in our clinical care delivery program.

It sounds as if you believe there are some things the VA health research program, because of its size and the strong connections between research and clinical care, is going to be better at than other institutions.

Yes. VA’s health systems research plays a role in helping VA be truly a learning health care system, and a laboratory for innovation that can improve the care of veterans, hopefully lead to cures for veterans, and also show 21

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The Year in Veterans affairs & military medicine

Spinal Cord Damage Research Center; James J. Peters VA Medical Center; www.scirc.org

■■ Investigators at the James J. Peters VA Medical Center in the Bronx, New York, have been evaluating the ReWalk™ exoskeleton walking device, which allows paraplegics to walk again. It recently gained FDA approval.

others what to do. We have the opportunity to measure outcomes and make a difference.

For example, we look at not just what VA does, but what everybody has done, and ask: How much difference do wait times make? What’s going to make a difference to a clinical outcome? We all know the answer, honestly, is that for the most part, we don’t know. But having asked the question now, we’re in a position to examine the data this health care system gathers together every single day and, first of all, validate that we actually know what those wait times are. And then to look for outcomes so that we can figure out whether [we] need to make it possible for every veteran, for every purpose, to be able to walk in as you might walk into a Minute Clinic and be seen and treated immediately – which is pretty expensive. Or might it be OK for a veteran who says they’ve got issues 1, 2, and 3 to

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wait a week, or a month, or two months in order to see a physician?

We’re also well positioned to investigate the efficacy of connected care and telemedicine. It may be possible for a veteran to see that physician not by walking into a clinic but by essentially Skyping on their computer. Maybe as a result of this Internet of devices, they could measure blood pressure and temperature at home, send that data in and describe their conditions. And then the physician or maybe a nurse practitioner can say either: “Well, you really need to come in and do some more tests,” or “take two aspirin and if you don’t feel better in the morning, give us another call.” To a greater and greater extent, we are investing in the issue of how to move that care out of the hospital and into a person’s home.

Nobody I know of – including myself – loves being a hospital patient. And so our health systems research is aimed

at getting people good care, keeping them out of hospitals, treating them wherever they may be. I think this is a very important part of what we do.

Finally, I think the commitment the VA and VA research have to optimizing the health care system through the use of good science is unique, because we don’t optimize that health care system to make money. We optimize the health care system to optimize health outcomes. Every hospital system does optimization work, but they’re focusing on a bottom line: reimbursement from insurance and Medicare. We pay attention to our bottom line, because we have to; Congress appropriates our money. But our health systems research is not aimed at improving the bottom line. It’s aimed at improving veteran health. And I think that’s a unique contribution that we make, and it allows us a different approach than that of anybody else in this arena. n 23

The Year in Veterans affairs & military medicine

VA Research:

Post-deployment Health n The ways in which VA health care, and the research efforts that support it, are administered and delivered acknowledge that military deployments may have involved experiences or exposures that many Americans – and often many veterans – have not encountered. VA’s health care system has been shaped over the past decade by the distinguishing characteristics of post-9/11 warfare.

The conflict that began in 2001 as Operation Enduring Freedom (OEF), and which has involved Operations Iraqi Freedom (OIF) and New Dawn (OND), has been America’s longest war, with many service members deploying multiple times to Southwest Asia over a span of more than 13 years. The most common cause of combat injury among veterans of these operations is blast injury, which can be inflicted from sources 24

including artillery, rocket and mortar shells, mines, aerial bombs, and rocket-propelled grenades, but has been most commonly caused by improvised explosive devices (IEDs).

Battle in Afghanistan and Iraq has taken a considerable toll on service members returning to civilian life. According to a report issued by the Congressional Research Service (CRS) in February of 2014, casualty statistics among these service members include, as of Dec. 31, 2013: • 118,829 diagnosed cases of post-traumatic stress disorder (PTSD) • 287,911 diagnosed cases of traumatic brain injury (TBI), 7,224 of which are classified as “severe or penetrating” • 1,558 major limb amputations (Last year’s CRS report, which included “minor limb” amputations, such as fingers

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U.S. Air Force Photo by Staff Sgt. Christopher Hubenthal

By Craig Collins

The Year in Veterans affairs & military medicine

Courtesy of DARPA

■■ Opposite: Dr. Gregory Johnson, Tripler Concussion Clinic medical director, has U.S. Army Spc. Andrew Karamatic, Department of Medicine combat medic, follow his finger with his eyes during a neurologic exam March 20, 2014, at Tripler Army Medical Center located in Honolulu, Hawaii. Between 2002 and 2013, more than 288,000 military service members have suffered from traumatic brain injury. Right: The DEKA Arm System is capable of handling objects as delicate as grapes and eggs, and also manipulating power tools, such as a hand drill.

or partial foot amputations, listed 1,715 total amputations among service members as of Dec. 3, 2012).

Blast injuries often involve polytrauma, meaning they affect multiple body systems or organs. Because of improvements in body armor and in-theater trauma care, a growing number of service members have survived polytrauma they would not have survived in previous conflicts. These service members return to civilian life with complex injuries that can include TBI; limb loss; burns; mental health issues; nerve damage; wounds; and loss of vision, hearing, or balance.

The VA and Department of Defense (DOD) have both stepped up research efforts with initiatives designed to help service members and veterans recover from the “signature wounds” of Iraq and Afghanistan, including limb loss.

For the past four years, VA researchers, in partnership with investigators from Brown University, have been evaluating a sophisticated robotic arm developed by DEKA Research and Development Corporation under the Defense Advanced Research Projects Agency’s (DARPA’s) Revolutionizing is that the arm is working for people.

Prosthetics program. A motorSo the FDA approval, coupled with ■■ The unprecedented ized mechanical arm equipped with the preliminary results from the number of polytrauma finely calibrated sensors that allows take-home study – I hope those two survivors has presented a users to unlock doors with keys or things are going to lead to a manuuse power tools, the DEKA arm is facturer saying: ‘Hey, I think this is unique challenge to VA’s the most advanced upper-limb prossomething we can manufacture and health care providers thetic ever tested by the VA. make available to our veterans and and researchers, who Following on the VA’s rigorous service members.”’ evaluations, the DEKA arm was To help veterans with polytraucontinue to work approved for the commercial matic combat injuries recover and together to address the market by the U.S. Food and Drug rehabilitate, the VA developed multiple issues – the Administration (FDA) on May 9, the Polytrauma System of Care, a 2014. The approval paves the way hub-and-spoke system organized comorbidities – resulting for the arm to be manufactured around five polytrauma rehabilitafrom post-9/11 combat. and made available for purchase tion centers (PRCs), which provide by the VA health system – a landacute inpatient rehabilitation; 23 mark development in upper-limb polytrauma network sites providing prosthetics for veterans, according to the VA’s Director of TBI-related care, referrals, and education services; and polyDeployment Health Research Dr. Robert Jaeger. trauma support clinic teams, which evaluate, monitor, and “The last outstanding issue,” he said, “is who is going to man- support veterans with positive TBI screens. ufacture this arm and make it commercially available. We’ve The unprecedented number of polytrauma survivors has collected data, both in the VA medical centers and currently presented a unique challenge to VA’s health care providers in a take-home study in which veterans are taking the arm and researchers, who continue to work together to address home and using it unsupervised every day. We don’t have any the multiple issues – the comorbidities – resulting from results to report from that study yet, but our initial impression post-9/11 combat.

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To better understand the health care needs of the combatinjured – and to promote their successful rehabilitation, psychological adjustment, and reintegration into the community – the VA has established, as part of its Quality Enhancement Research Initiative (QUERI), the Polytrauma and BlastRelated Injuries (PT/BRI) QUERI, aimed at improving and refining the overall Polytrauma System of Care and improving veterans’ ability to manage persistent symptoms and functional impairments related to polytrauma and TBI. According to Jaeger, evaluating outcomes in a nationwide system of polytrauma care is a new frontier in health services research.

“We see polytrauma in civilian society, of course,” he said, “but we don’t see it on the scale we see among the casualties coming back from combat. I think ultimately the Polytrauma Centers are going to tell us a lot, build our knowledge about medicine in this area. But I think we’re still very much in the data collection and research phase.”

Photo by Brandy Gill, CRDAMC Public Affairs

Building Resiliency: New Insights

The broad scope of the PT/BRI QUERI’s research is an indication of just how complicated it can be for OEF/OIF/OND veterans – many of whom have worked in a state of constant alertness to danger, and perhaps witnessed disturbing events – to heal, rejoin their families and friends, and enjoy civilian life.

More than a million mental health conditions have been diagnosed among active-duty service members since 9/11.

A 2011 VA study of OEF/OIF veterans using VA health care reported that more than 11 percent had been diagnosed with a substance use disorder; VA data shows that percentage jumps to 22 percent among veterans with PTSD. Over the past several years, suicide rates among OEF/OIF/OND veterans have spiked – particularly among younger veterans and females – and the DOD and VA have stepped up their prevention efforts. A study of OIF veterans has reported a link between combative behaviors – angry verbal outbursts, threats, and property destruction, for example – and violent combat exposure; other studies have shown that OEF and OIF veterans also experience high levels of conflict in family and social relationships.

How well a veteran adapts to postwar life is a complex problem involving psychiatric, social, biological, and environmental factors that, until 2009, tended to be studied separately. One of the first studies to examine them in context – to more fully understand who will struggle with post-combat stress, and why, and when it is most likely to begin impairing function – was the VA’s Marine Resiliency Study, a longitudinal evaluation of about 1,650 Marines conducted from 2009 to 2012 by an investigative team led by Dr. Dewleen Baker, research director for the San Diego Veterans Affairs Center of Excellence for Stress and Mental Health.

The first study to evaluate Marine resiliency, the study involved exhaustive surveys, blood and urine tests, genetics, medical record inventories, and behavioral assessments – evaluations

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■■ Fort Hood soldiers receive their Post Deployment Health Assessment and their Post Deployment Health ReAssessment at the Fort Hood Soldier Readiness Processing Center. Every soldier who returns from deployment is required to complete these assessments.

made before, during, and after deployment – to explore the interaction of risk factors among subjects and to determine which factors contributed both to PTSD and to resilience.

Baker and associates are still combing through the mountain of data yielded by the study. One of the most startling early results, reported in early 2014, was that the strongest predictor of PTSD among subjects was blast injury: Moderate or severe brain trauma raised PTSD symptom scores by 71 percent, while mild TBI increased PTSD scores by 23 percent.

Other factors, such as the heat of combat or pre-existing conditions, were influential in developing PTSD, but none were as strong a predictor as blast-caused TBI. The ability to study a group of Marines over time, as they passed from the DOD into the VA system, was enabled by a long-standing collaboration between military and VA researchers. This collaboration was expanded with last summer’s launch of the National Research Action Plan, a joint effort by the VA, DOD, and the Department of Health and Human Services to improve scientific understanding, develop effective treatments, and reduce the occurrence of mental health conditions such as TBI and PTSD, as well as the behavioral issues that often accompany them, among service members and veterans.

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The Year in Veterans affairs & military medicine

Mental health conditions, unlike the loss of a limb, are largely invisible, which makes them more complicated both to detect and treat among warriors. While the stigma often attached to mental health conditions has largely been eliminated along the military’s chain of command, it has tended to persist in a culture where one is often judged by his or her ability to ignore mental or emotional turmoil.

But one of the most intriguing research findings in recent years has been the correlation between biomarkers – specific chemical compounds, hormones, or proteins found in the blood or cerebrospinal fluid – and the occurrence of both TBI and PTSD. VA studies have shown that PTSD and TBI aren’t just mental disorders – they affect several molecular pathways in the brain – and in the summer of 2014, VA researchers also discovered biomarkers that correlated with suicide risk. In June, investigators at the Durham, North Carolina VAMC found a correlation between high and low levels of certain proteins in the blood serum of veterans who reported suicidal thoughts. In July, researchers at the Bronx VAMC conducted post-mortem examinations of the brain cells of people who had died by suicide, and discovered the faulty expression of a specific protein that helps in mood regulation.

PTSD and suicidal ideation are complex conditions, and it remains unclear how the discovery of these biomarkers may someday translate into a clinical solution that will help to detect or treat them in patients. But to Jaeger these discoveries are among the most promising recent developments in post-deployment health research.

“Diabetes patients today have devices on the market that are commercially available, at low cost, to measure their blood sugar,” he said. “And those numbers are used by their doctors to help manage diabetes in the chronic state, not only to diagnose it, but to treat it,” he said. “So the goal with these biomarkers is to have something – a blood test or a neural imaging – that will allow a person with one of these conditions to measure a biomarker.”

Such measurements could suggest whether a treatment is working, a condition is worsening, or a patient’s mental health issues are resolving.

While there’s still much ground to be covered before these biomarkers might be of practical use, it seems plausible, even likely, that they might someday help make “invisible” conditions such as stress or suicidal ideation as visible and treatable as other battle wounds – and that veterans will be better equipped than ever to thrive back in the world. n

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Airborne Hazards Research Gearing Up n The potential for deployment-related occupational and environmental exposures to cause health problems has been a subject of study for the VA since the Vietnam War, when the agency created a registry for veterans who had been exposed to the chemical herbicide known as Agent Orange. A similar registry was created for veterans of the first Gulf War – and in the past year, one has been formed for post-9/11 veterans.

VA will be conducting a pilot epidemiologic research study to characterize the impact of deployment to Iraq and Afghanistan on the respiratory health of veterans.

More specifically, this study plans to: (a) determine the most efficient and feasible method for recruiting veterans; (b) understand demographic, health-related, and military service-related factors influencing participation to inform analytic strategies; and (c) demonstrate that a method for reconstructing individual exposures based on deployment history can be done. The intent is to help better inform the planning, conduct, and analysis of a potential larger, national study for assessing the residual effects of exposure to high levels of particulate matter while deployed.

A study by the Institute of Medicine (IOM) of the National Academy of Sciences (NAS), undertaken at the request of the VA and made public in 2011, was inconclusive. In a notice published in the Federal Register in February of 2013, the VA characterized the IOM report in this way: IOM concluded that there was limited but suggestive evidence of an association between exposure to combustion products and reduced pulmonary function, but inadequate or insufficient evidence of an association between exposure to combustion products and cancer, respiratory diseases, circulatory diseases, neurologic diseases, and adverse reproductive and developmental outcomes in the populations studied.

After reviewing the IOM report, then-Secretary of Veterans Affairs Eric Shinseki directed the Veterans Health Administration to conduct a long-term prospective study on all adverse health effects that might be related to deployment in Iraq and Afghanistan, including health effects potentially related to exposure to airborne hazards and burn pits.

On a different front, the Airborne Hazards and Open Burn Pit Registry is available to all eligible veterans. Veterans and service members can use the registry questionnaire to report exposures to airborne hazards (such as smoke from burn pits, oil-well fires, or pollution during deployment), as well as other exposures and health concerns. The registry will help to monitor health conditions and VA will use the data to improve programs to help veterans and service members with deployment exposure concerns.

Service members and veterans can access the registry and sign up at https://veteran.mobilehealth.va.gov/ AHBurnPitRegistry/#page/home .

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The Year in Veterans affairs & military medicine

VA Research:

CANCER

By Craig Collins

n From the start of the VA’s cancer research is tailored to support the care of the VA’s 40,000-50,000 program – the organization’s first centrally funded research cancer patients. “Roughly half of the VA patients who are laboratory was established in Hines, Illinois, in 1932 – its seen in VA medical schools or medical centers are over investigators have contributed to the world’s knowledge of 65,” he said. “And of course as a person gets older, cancer how to prevent, detect, and treat cancer. VA researchers were becomes a growing problem – aging is a risk factor, if you among the first to identify, in the 1940s, the link between will, for cancer. So having a very active and strong research smoking and lung cancer; they program supports the VA’s health also developed the nicotine patch, care for older veterans.” discovered the colonoscopy as a Several decades’ worth of ■■ “Roughly half of superior screening tool for colon studies have allowed physicians cancer, conducted some of the to treat primary tumors, if they the VA patients who first studies measuring the effects are detected early enough, with are seen in VA medical of radiation on cancer cells, and increasing success through comschools or medical established that careful observabinations of surgical, chemotheration is as effective as invasive surpeutic, and radiological intervencenters are over 65. And gery in treating early-stage prostions. For many patients, however, of course as a person tate cancer. these primary tumors have already gets older, cancer “Cancer” is a general term for metastasized – and metastatic more than 200 different diseases cells, for reasons not yet underbecomes a growing that occur when the body’s cells stood, are much more difficult to problem – aging is a suffer damage to their genetic treat or kill than primary tumor risk factor, if you will, coding (DNA), start to grow out cells. “And to compound that of control, and sometimes invade problem,” said Dr. Alan Wells, the for cancer. So having a and destroy other body tissues.

VA physician who directs the clinvery active and strong Among VA patients, the five most ical laboratories at the University research program commonly diagnosed cancers are of Pittsburgh Medical Center, “the prostate, lung, colorectal, genitometastases often are cryptic. We supports the VA’s health urinary (i.e., kidney and bladder), don’t know that they’ve metastacare for older veterans.” and skin cancers. sized yet.” Many metastatic cells VA cancer researchers – many revert to a period of dormancy at of them practicing physicians at the site of metastasis and go undeVA health care facilities – contected – both by medical science duct a broad range of basic science, translational, and and by the body’s own immune system – for an extended clinical studies, including studies aimed at improving the period before reactivating and proliferating. quality of and access to VA cancer care. According to the For more than 20 years, the VA has funded the work of cancer research program Portfolio Manager and Senior Wells and his researchers in studying metastases of breast Scientific Officer Dr. Ralph Paxton, the research program and prostate cancers; in recent years, these studies have 30

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The Year in Veterans affairs & military medicine

Photo courtesy of DARPA/ Wyss Institute

■■ Harvard University’s Wyss Institute’s “lung on a chip,” a platform that uses engineered human tissue to mimic human physiological systems. The interactions that candidate drugs and vaccines have with microphysiological systems (MPS) such as these will accurately predict the safety and effectiveness that the countermeasures would have if administered to humans. As a result, only safe and effective countermeasures will be fully developed for potential use in clinical trials, while ineffective or toxic ones will be rejected early in the development process.

focused more specifically on what happens in the early stages of metastasis: “What are the things that protect [metastasized cells] when they are even not seen yet?” said Wells. “What makes them go into dormancy? And why do they then rise out of dormancy and grow into angry large metastases that end up killing our veteran patients?”

To answer these questions, VA investigators are studying metastases in human models – engineered human tissues, known as microphysiological systems, or MPS. Testing the resistance of metastases in an animal model, said Wells, would be irrelevant: “Animals don’t respond the same way to drugs,” he said. “A lot of the signals between the tumor cell and the body are very species specific.” What’s more, these signals often vary among individual people, which is why he and his team are hoping to expand the variety of tissue samples. The MPSs being used now are engineered from lung or liver metastases

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removed from patients during surgery; with funding from the National Institutes of Health, the team hopes to develop stem cells to the point where they can be used to build MPS tissues.

“That would both be more consistent and allow us to sample a greater diversity of people,” said Wells.

Chief of Hematology-Oncology Dr. Matthew Rettig practices at the West Los Angeles VAMC and is a professor of medicine at the University of California-Los Angeles, studying the molecular and cellular biology of cancer cells, with an emphasis on genitourinary cancers. Some of these studies involve comparing the genome sequencing and protein makeup of metastatic and circulating cells – cells that break off from the primary tumor and enter the bloodstream – to cells of the primary tumor. If the team’s biostatistical analysis of circulating cells shows they have a similar molecular profile, it would suggest they might respond to similar therapies. “We 31

The Year in Veterans affairs & military medicine

can then analyze … over time the molecular evolution of cancers,” said Rettig, “not only their natural history but also their responses to therapies. So instead of trying to get a biopsy from a patient, which can be difficult, we can get a simple blood draw to molecularly analyze a tumor.”

Studying the mechanisms of metastasis – down to molecular analysis of primary, circulating and metastatic cancer cells – has obviously wide-ranging implications for the prevention and treatment of all types of cancer. But the discoveries being made by VA cancer researchers investigating issues that are more particular to an older population of cancer patients are no less significant. At the Indianapolis VAMC, for example, the research of Dr. Jeffrey B. Travers, dermatologist and Indiana ■■ Gracie Hoal, a nurse practitioner at VA’s Comprehensive Mesothelioma University School of Medicine professor of Center in Los Angeles, listens to the heart of George McDermott, an medicine, has shown that older skin han84-year-old Korean War veteran who served in the Navy. Mesothelioma is dles sunlight differently – its cells are more an asbestos-related cancer. likely to suffer irreparable DNA damage, which can begin the chain of events that result in skin cancer.

“We’ve shown that this difference is due to fibroblasts in average patient who has non-melanoma skin cancers,” said the skin,” said Travers. “As they age, they make less of a hor- Travers. “But for patients who have had multiple squamous mone called IGF-1.” Fibroblasts play a critical role in wound cell carcinomas, and who are also immunosuppressed, I healing; the IGF-1 (insulin-like growth factor 1) they pro- think it would be a wonderful thing. And to me it would seem duce will decide the fate of keratinocytes above them that like a very simple type of therapy, because there is an abnorreceive DNA damage from sunlight that they cannot repair. mality in how they respond to sunlight that we can repair.”

In younger individuals whose fibroblasts make adequate In Texas, Dr. Rhonda Souza, a Dallas VAMC physician and amounts of IGF-1, these UV-damaged keratinocytes are not professor of medicine at the University of Texas Southwestern allowed to proliferate. However, in older individuals, the lack Medical Center, is part of a team that has launched basic and of IGF-1 in the skin allows UV-damaged keratinocytes to pro- clinical studies looking into the continued susceptibility of liferate, forming precancerous actinic keratoses or squamous patients with Barrett’s esophagus – an abnormal change in cell carcinomas. The result is that for older patients, relatively the cellular makeup of the lower esophagus – to the formasmall amounts of sunlight can predispose to actinic neo- tion of esophageal adenocarcinoma, an often deadly cancer. plasia, which are the most common types of cancers found in Barrett’s esophagus, in turn, is strongly associated with veterans. While non-melanoma skin cancer is rarely lethal gastroesophageal reflux disease (GERD) – a condition caused in the general population, mortality due to squamous cell by the backwash of stomach contents into the esophagus. carcinomas in immunosuppressed populations such as solid GERD is a treatable condition, most often with the group of organ transplant populations can be significant. drugs known as proton-pump inhibitors (PPIs), which block Travers and his colleagues have discovered two means of the release of acid by cells in the stomach – but the incidence stimulating the fibroblasts of older patients to produce more of esophageal adenocarcinoma has increased steadily in IGF-1: first, dermabrasion – literally roughing up a localized recent years despite the widespread availability of these acidarea of skin with a sandpaper-like abrasive – and also frac- suppressive treatments. tionated lasers, which pierce tiny holes in the skin to stimDallas researchers, with VA funding, have established that ulate repair. “We don’t anticipate using lasers to treat the GERD complications are not just caused by the release of 32

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VA Photo by Svetlana Kotova

Preventing Cancer in Older Patients

The Year in Veterans affairs & military medicine

stomach acids, which can be treated with PPIs, but also by bile salts, produced by the liver, stored in the gall bladder, and released into the intestine during digestion. Using cell lines developed from Dallas VAMC patients with Barrett’s esophagus – and then in studies performed during endoscopies with patients – these investigators revealed that Barrett’s cells treated separately with both gastric acid and bile salts (in concentrations that are found routinely in the esophagus of Barrett’s patient) developed DNA damage. Acid and bile salts also activated a protein complex, NF-kappaB, that stimulated the survival of these damaged cells.

Following on these results, a team of clinical researchers that included Souza’s longtime colleague Dr. Stuart Spechler, demonstrated that the application of a compound often used to treat patients with liver disease – ursodeoxycholic acid, or Urso – could prevent both the DNA damage and NF-kappaB activation that occurred with the application of bile salts. “So we thought: ‘Well, I wonder if we put our patients who are already on a PPI on Urso … could we actually prevent that DNA damage?’

So we did. We put them on eight weeks of Urso and brought them back to the endoscopy suite and once again perfused their esophagus with bile salts. We were pleased to find that after the eight weeks of Urso treatment the bile salts no longer induced DNA damage or NF-kappaB in the esophagus.”

The studies suggest that Urso might be used as a preventive measure, and ensuing investigations have helped explain just how it works on a molecular level. Souza and her colleagues are preparing for the next round of studies, designed to evaluate whether Urso could also be used to repair DNA damage in the esophagus.

Seeking New – and Improved – Treatments

The ability of researchers to alter variables at the molecular level is in the process of revolutionizing cancer medicine. In Los Angeles, for example, Rettig directs a prostate cancer drug screening program, evaluating the ability of an estimated 200,000 compounds to block the site on the prostate cell’s male hormone receptor that drives the development and proliferation of prostate adenocarcinoma.

In Indianapolis, Travers is studying the link between ultraviolet light exposure and the production of platelet-activating factor (PAF), a lipid activator that contributes to inflammation and suppresses immunity. The link, which he has demonstrated in mice, has significant implications for cancer treatment; PAF is also made in response to cancer treatments. “If you give a mouse chemotherapy or radiation therapy,” Travers said, “it will, in addition to killing the tumor, also produce this lipid mediator, which then induces regulatory T cells, which actually inhibit tumor immunity.” In VA-funded preclinical studies, his team has found that this immunosuppressive effect may be blocked with the use of a drug known as a COX-2 inhibitor, which targets a cellular enzyme responsible for inflammation.

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The team’s study was recently accepted for publication in the Journal of Investigative Dermatology. “If we’re correct,” said Travers, “in the future when people get chemotherapy, radiation therapy, or photodynamic therapy, it’s going to affect the standard of care: Will they get a COX-2 inhibitor at the same time to block this untoward effect?”

Because intracellular increases in COX-2 enzyme are associated with many epithelial cancers – not just skin cancer – COX-2 inhibitors, such as celecoxib, have long been evaluated as possible therapies for these tumors. But according to Dr. Amy Fulton, a VA breast cancer researcher and associate director for basic research at the University of Maryland’s Greenebaum Cancer Center, clinical trials of COX inhibitors have found them, as did Travers’ team, to also inhibit the release of compounds that serve to protect the cell.

“We decided several years ago,” said Fulton, “to try to move downstream in that COX-2 pathway, and be more selective in inhibiting particular aspects of it instead of the entire pathway.” The Maryland team has found, for example, that older COX inhibitors inhibit the production of prostaglandin E2, a lipid that mediates many of the processes by which tumors grow and metastasize. Further analysis of cell receptors reveal that different receptors, on the same cell, respond differently when they bind to prostaglandin E2: one receptor will promote metastasis and induce immunosuppression, for example, while another will inhibit metastasis.

In follow-on studies, said Fulton, her laboratory revealed that a subset of malignant breast cells, the breast cancer stem cells, which are highly resistant to therapy, significantly increase the number of PGE2 receptors known to encourage tumor formation and metastasis – but the good news is that they’re also more sensitive to inhibition with PGE2 receptor antagonists than other tumor cells. “So we think what that’s going to mean, if this is relevant to human cancer, is that you probably would be able to inhibit the majority of tumor cells with conventional therapies,” she said. “But the tumor cells that are going to grow back and get you in the end, these cancer stem cells, will be exquisitely sensitive to antagonists at these receptors.”

Fulton and her team have designed a clinical trial of a drug to be tested against breast, prostate, and lung cancer, three cancers known to up-regulate the prostaglandin E2 receptors. While investigators believe the drug may be useful for all three types of cancer, results from the different groups may help broaden the knowledge base about effective treatments for cancer – and perhaps one day lead to a cure.

“Laboratory scientists like me,” said Fulton, “don’t often get to see the clinical application of their studies. They hope somebody’s going to take those findings and do something with them clinically to really help people, but it doesn’t always happen in their lifetimes. So I’m actually quite excited that not only do we have an agent we can test, but that we have the clinical collaborators in the VA system who are interested in going further to bring this solution to patients.” n 33

The Year in Veterans affairs & military medicine

VA Research:

Spinal Cord Injury

By Craig Collins

n About 273,000 Americans have a spinal cord injury or disorder (SCI/D) that significantly affects their lives, and the Department of Veterans Affairs (VA) estimates that more than 45,000 of these are eligible for VA health care. That’s a lot of people, many of them in a lot of pain – but statistically, it’s a small percentage of the 6.6 million veterans who used VA health care in 2014.

According to Dr. Robert Jaeger, the VA’s director of deployment health research, SCI/D is sometimes referred to as an “orphan” condition in the medical research community: “The population of individuals who have a spinal cord injury, and the incidence of spinal cord injury,” he said, “is small compared to some other health conditions.” For example, the Centers for Disease Control and Prevention found that there are around 67 million Americans who suffer from high blood pressure, and nearly 9 million of them are veterans, according to the National Institutes of Health. This disparity often limits the incentive of private industry to create a market for drugs, therapies, or assistive technologies for SCI/D patients, or to engage in the expensive pursuit of a “cure” for SCI – a cure that is beginning to seem, through the efforts of VA researchers and their partners, increasingly plausible.

The VA’s mandate is to care for all veterans, and those with SCI/D suffer many life-threatening and chronically debilitating health consequences in addition to the resulting loss of mobility and sensation. To address these consequences, the VA has established the largest single network of SCI/D care in the nation, a hub-and-spoke system extending from 24 regional centers to 134 primary care teams at local VA medical centers.

The VA’s ambitious research portfolio supports this system of care by exploring the complex medical and social issues associated with spinal cord injury, and by investigating ways in which an injured spinal cord might repair itself and restore neuromotor function. VA spinal cord research addresses the challenges confronting individual patients, as well as the issues involved in caring for veterans with SCI/D. 34

VA researchers have made strides in restoring some degree of strength, balance, and motor function to SCI/D patients through technologies – Functional Electrical Stimulation (FES), Functional Neuromuscular Stimulation (FNS), and now neuroprosthetics – that apply electric stimulation to motor neurons. Researchers at the Cleveland FES Center – a consortium involving the Cleveland VA Medical Center (VAMC), the National Institutes of Health, Case Western Reserve University, and Cleveland’s MetroHealth System – are currently wrapping up a 10-year evaluation of a surgically-implanted electrical system that stimulates the muscles of the trunk and legs to allow for standing, improved balance, and exercise.

One of the most intriguing questions being pursued by researchers is how damage to the spinal cord might be repaired and function restored. In 2010, the VA and several of the nation’s leading academic researchers established a consortium – now known as the Gordon Mansfield SCI Consortium – to pursue the high-risk, high-return ideas that otherwise would be unlikely candidates for funding.

Healing an injured spinal cord has proved more complicated than healing other tissues. The scarring caused by injury

■■ “This is brand-new territory. If we do get this to work in a more chronic model, this opens up the possibility of regeneration for people who have had spinal cord injuries for a year or so. We may be able to perform transplants that could help them.”

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The Year in Veterans affairs & military medicine

va research Photo by Kevin Walsh

■■ Dr. Mark Tuszynski of the VA and the University of California, San Diego (left), seen here with associate Dr. Ephron Rosenzweig, is seeking ways to regenerate injured spinal cord tissue.

releases compounds that interfere with the neurochemical processes required for regenerating axons, the slender projections of nerve cells extending out from the cells’ main bodies.

In addition to this scarring, a cavity forms on the inside of the injured spinal cord, leaving an empty space that had been packed with active neurons.

In the past few years, a corps of investigators led by Dr. Mark Tuszynski, a San Diego VAMC physician and director of the Center for Neural Repair at the University of California-San Diego, has achieved several milestones in neural regeneration. In one of these studies, reported in 2012, a team led by Dr. Paul Lu transplanted human neuroprogenitor cells (an intermediate cell type, between a stem cell and a neuron) into a rodent spinal cord that had been completely severed.

Researchers then applied a carefully engineered combination of factors – biological substrates, and growth-enabling proteins – that allowed the transplanted cells to extend axons over a distance of several inches, bridging the scar tissue and forming functional connections that allowed for the recovery of some hind-limb function.

“This is actually a very seminal study,” said Dr. Audrey Kusiak, scientific program manager for VA’s spinal cord research. “It’s the

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first demonstration of human neuroprogenitor cells surviving and forming connections in the rodent spinal cord.”

As the consortium begins its fifth year, Kusiak said, investigators will attempt to replicate Lu’s results in non-human primates at the National Primate Research Center at University of California-Davis: transplanting and integrating human neuroprogenitor cells, stimulating axonal growth with rehabilitation, and measuring their longevity. Researchers are also planning delayed transplants in some primate subjects, to make the research more clinically relevant to the veteran population. “We do have some pilot data on one animal,” said Kusiak, “and it’s very promising. This is brand-new territory.

If we do get this to work in a more chronic model, this opens up the possibility of regeneration for people who have had spinal cord injuries for a year or so. We may be able to perform transplants that could help them.”

SCI’s Collateral Damage

The spinal cord is the brain’s neural pathway to virtually every part of the human body – the skin, muscles, internal 35

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The Year in Veterans affairs & military medicine

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■■ Sgt. Theresa Hannigan at the finish line of the Hope for Warriors walk/run fundraiser in New York. She walked a mile using the ReWalk™ exoskeleton, a motorized orthotic device.

organs, and glands – and damage to it involves severe complications, including limb paralysis, respiratory difficulties, blood clots in the veins and the lungs, impaired temperature and blood pressure regulation, loss of bladder and/or bowel control, hormonal imbalances, and repeated infections of the pulmonary, renal, and urinary systems.

These consequences make spinal cord injury a chronic condition; SCI appears to accelerate the aging process, increasing risks for cardiovascular, musculoskeletal, metabolic, and other conditions often associated with the older population. For example, SCI can result in the loss of 60 percent or more of the bone and muscle tissue in the legs.

Drugs aimed at reversing these losses, such as bisphosphonates, involve short- and long-term adverse effects, but bone and muscle loss are a significant concern for both clinicians and researchers, who remain optimistic about the prospect of a “cure” for spinal damage: Musculoskeletal integrity is

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important not only to improve strength and balance and prevent fractures associated with falls, but also to preserve one’s physical integrity for future cell-based or orthotic therapies.

VA investigators at Stanford University and the Palo Alto VAMC are developing a new approach to restoring muscle density that includes the engineering of vascularized muscle tissue for transplant in rodent models. Because there are different types of muscle tissues, but a limited number of muscle stem cells available to replenish lost muscle, muscle tissue engineering is difficult – but the studies so far suggest that muscle can be engineered with the desired properties.

Researchers and clinician investigators throughout the VA’s SCI/D care network conduct research devoted to improving the quality of life for people with spinal cord injury. An important research hub is the Center of Excellence on the Medical Consequences of Spinal Cord Injury, administered by VA’s Rehabilitation Research & Development Service at the Bronx 37

The Year in Veterans affairs & military medicine

VAMC in New York. Center of Excellence investigators seek to improve outcomes for SCI/D patients with complications related to the cardiovascular/autonomic, endocrine, gastrointestinal, pulmonary, genitourinary, musculoskeletal, and thermoregulatory systems; researchers in neurorehabilitation and physical activity work to restore lost neural function and movement, and help veterans with SCI engage in appropriate physical exercise.

The Bronx’s physical activity/quality of life research group, led by Dr. Ann Spungen, last spring conducted evaluations of a robotic exoskeleton-assisted walking technology developed by an Israeli scientist who was paralyzed in 1997. The ReWalk exoskeleton is a motorized orthotic device that is strapped on to the body and allows some individuals to walk with a more natural-looking gait with less energy consumption. Walking with long leg braces takes a lot of energy, and the ReWalk has the potential to reduce that energy consumption, and to help people with a spinal cord injury walk short distances. The device might enable patients to do everyday things around the house and possibly even get out and walk around in a store, for example.

One of the study’s participants, Theresa Hannigan, a paralyzed Army sergeant from Long Island, walked a mile in the ReWalk last fall, during a fundraiser for Hope for Warriors, a nonprofit that provides assistance to combat-wounded service members. Based on clinical studies, including the reporting from Spungen’s group, the U.S. Food and Drug Administration (FDA) cleared the device for use at home and in the community on June 26, 2014.

The SCI-QUERI: Improving Health Care Delivery to SCI patients

VA’s Quality Enhancement Research Initiative (QUERI), launched in 1998, is a research program aimed squarely at the health care setting, with the goal of enhancing the quality and outcomes of VA health care through the application of evidence-based research to clinical practice. There are currently 10 QUERI programs, including one dedicated to SCI care.

Dr. Charlesnika Evans, co-director of the SCI-QUERI at the Edward Hines Jr. VAMC in the Chicagoland area, said program investigators have identified four primary areas of focus for research and clinical practice: • Pressure ulcer prevention and management. Standards of care typically prevent pressure ulcers – or “bedsores,” injuries to the skin resulting from prolonged pressure over a bony prominence – from forming among VHA inpatients with SCI, so QUERI investigators, said Evans, are focused on the prevention and treatment of “community-acquired” pressure ulcers – those acquired outside the health care setting.

Among the QUERI projects underway in this area is evaluating implementation of an assessment tool, developed through VA funding, to monitor pressure ulcer healing: the 38

SCI Pressure Ulcer Management Tool (SCI-PUMT). QUERI investigators are finding variations, Evans said, in the way the PUMT is implemented, and its resulting data documented.

“What they eventually want to be able to do,” said Evans, “is to provide some best practices for using this data, for other facilities that want to use it effectively.”

• Infection prevention and management. SCI-QUERI researchers collaborated with VA SCI clinicians in improving influenza and pneumococcal vaccination rates among veterans with SCI/D. Between 2000 and 2010, veterans with SCI/D increased their influenza vaccination rates from 28 percent to 79 percent; their pneumococcal pneumonia vaccination rates rose from 40 to 94 percent.

QUERI researchers have identified a need to target health care workers for influenza vaccination. “This is actually an effort we are working on not only with the VA SCI/D services,” said Evans, “but also the VA Office of Public Health, which has a very strong interest in it. One of their goals is to improve health care worker influenza vaccinations across the VA, and so we’ve been working with them to implement a program to improve influenza vaccination rates among providers caring for spinal cord-injured veterans. This is really something we’re hoping could be used for the larger VA if shown to be successful.”

• Optimizing function. This is an emerging area of study within the SCI-QUERI, one currently being evaluated by researchers who plan to measure the implementation of and effectiveness of environmental control units – devices that allow patients to perform a number of simple tasks, such as changing the thermostat, signaling for assistance, or using the Internet.

• Implementation of virtual health care and consultation.

The use of Clinical Video Telehealth (CVT), secure messaging, and other virtual health technologies to connect providers with patients – and with each other – is a relatively new area of study for the SCI-QUERI. Because much of the VA’s SCI/D expertise is located at 24 regional centers, the use of CVT allows for the transfer of this expertise to patients in their homes or at local facilities. “The work we’re doing,” said Evans, “is focused on understanding the facilitators and challenges VA facilities confront in being able to provide this type of telehealth care. Eventually we hope to understand how veterans perceive the care and use of this technology, as well.”

To an outsider, it may be difficult to fathom that CVT technology, in terms of its impact of VA health care for SCI patients, may have implications as significant as those of the VA’s cutting-edge stem cell and tissue engineering researchers. Both point to a new era in the care and management of spinal cord injury: one in which many spinal injuries and their complications may be repaired or virtually erased, and others can be cared for and managed, anywhere in the world, with the expertise of some of the best SCI care specialists working today. n

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VA Research:

Diabetes

By Craig Collins

n Diabetes – a chronic disease in which the body cannot produce or properly use the metabolic hormone insulin, resulting in elevated blood glucose – has affected an outsized percentage of veterans. About 25 million Americans have diabetes – about 8 percent of the population – and nearly twice that number are at risk to develop the disease. By comparison, nearly one out of every four veterans using the VA health system has the disease.

The most common form, accounting for 90 to 95 percent of cases, is type 2 diabetes. It’s a devastating disease, with longterm complications that can affect every part of the body. It’s the leading cause of blindness, end-stage kidney disease, and amputation for VA patients, and often leads to stroke, nerve damage, and cardiovascular disease, which is the leading cause of death among all diabetics.

The VA’s diabetes research program is aimed at the disease from every angle, investigating the basic science underlying diabetes and its complications, better ways to prevent or treat the disease, and strategies or technologies that can be used by health care providers to maximize access to diabetes care and improve outcomes.

For 35 years, Dr. Jim Sowers, a VA investigator and director of the Thomas W. and Joan F. Burns Center for Diabetes and Cardiovascular Research at the University of MissouriColumbia School of Medicine, has conducted VA-funded research into the basic mechanisms by which diabetes promotes cardiovascular disease. He’s been a practicing endocrinologist for 43 years, currently at the Harry S Truman Memorial Veterans Hospital. “About two-thirds of all patients seen by cardiologists present with either diabetes or impaired glucose metabolism,” he said, “and diabetes is a promoter of atherosclerosis, myocardial infarction, and heart failure … so we’ve been exploring basic fundamental mechanisms underlying the cardiovascular disease that’s associated with diabetes.”

In studies that have focused primarily on rodent models, Sowers has studied the role of insulin resistance in high blood pressure and cardiovascular disease. “We’ve been studying animal models that have been fed Western diets high in fructose and fat,” he said. “We’ve been studying hormonal mechanisms or systems, such as the renin-angiotensin-aldosterone system [RAAS], involved in diabetes-related cardiovascular disease.”

40

The RAAS is the hormone system that regulates blood pressure and blood volume. “We’ve also explored how this diet promotes high blood pressure and cardiac disease.”

These explorations, said Sowers, are laying the groundwork for investigations into interventions – both behavioral and medical – that can improve clinical outcomes for diabetic veterans.

For example, in his own work, Sowers has explored the efficacy of diuretics and angiotensin receptor blockers in preserving the insulin response in obese subjects with hypertension.

The relationship between diabetes and cardiovascular disease long has been known, if not completely understood, but VA researchers have also uncovered associations between the disease and other conditions. Researchers from the San Francisco VAMC and the University of California-San Francisco recently found that cognitive decline tended to occur more rapidly, over a nine-year period, among diabetic patients over 70 than among those who did not have diabetes at the outset. In February 2014, a team led by researchers from the VA Puget Sound Health Care System found that service members who suffered from sleep disorders, such as insomnia or sleep apnea, carried a higher risk for diabetes.

Dr. Leonard Pogach, the VA’s former program director for diabetes and now its national director of medicine, cautions that these observational associations, without a randomized clinical trial to further isolate other variables, cannot imply a cause/ effect relationship – and therefore it’s inappropriate to conclude that treating one condition will have any effect on another.

“Clearly there are associations between diabetes and things such as sleep apnea, cognitive dysfunction, and decreased hearing,” Pogach said, “but we have to try to understand the reasons for these associations. For example, cognitive impairment: Is it due to glycemia [blood glucose], or is it due to underlying vascular disease, which is often common with people with type 2 diabetes and may have occurred for many years beforehand?

Or do both contribute? … It’s not accurate to state that you need to treat a certain condition because it will prevent X, Y, or Z.” Exploring Prevention and Treatment

One recent clinical trial that may help refine our understanding of diabetes was reported in the June 12, 2014, New

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The Year in Veterans affairs & military medicine

Photo by Larry Gilstad

■■ Dr. Andrew Schally (right) of the Miami VA Medical Center, a 1977 Nobel Prize winner, is part of an international team that has developed a new type of artificial pancreas. On the left is lab manager Ricardo Rincon.

England Journal of Medicine by a team including researchers from the Philadelphia VAMC, the University of Pennsylvania, and Temple University School of Medicine, who explored the effects of treatments for weight loss and sleep apnea – a condition strongly linked to obesity – on 90 patients. To separate the risks obesity poses compared to those posed by sleep apnea, the team divided subjects into three groups: those who were treated only for obesity; those who were treated only for sleep apnea with the use of a continuous positive airway pressure (CPAP) system; and those who were treated for both issues.

The team found that a 24-week weight-loss program, whether it was accompanied by CPAP therapy or not, significantly reduced inflammation and insulin resistance. CPAP therapy alone did not provide these benefits – but did reduce blood pressure. The two treatments combined produced the largest declines in blood pressure. In an interview with Reuters after the study was reported, lead author Dr. Julio Chirinos of the Philadelphia VAMC summed up the study’s primary implication: “Whether or not you get CPAP,” he said, “the weight loss is the essential component for reducing cardiovascular risk. It’s obesity that needs to be targeted.”

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The treatment for type 2 diabetes involves lifestyle interventions, the reduction of other cardiovascular risk factors, and glycemic control with the use of medication.

VA researchers are participating in a five-year National Institutes of Health (NIH) study aimed at expanding our knowledge of diabetic drugs commonly used in combination with Metformin, the first-line treatment used by physicians. The Glycemia Reduction Approaches in Diabetes (GRADE) trial is expected to include 5,000 participants nationwide, and will compare the long-term risks and benefits of four widely used drugs: sulfonylurea, which directly increases insulin levels; DPP-4 inhibitor, which boosts insulin levels indirectly by stimulating the release of an intestinal hormone; GLP-1 agonist, which increases the amount of insulin released in response to nutrients; and long-acting insulin.

VA researchers are also conducting an innovative “pointof-care” study of 3,000 veterans with diabetes, comparing the outcomes for two methods of insulin administration: the sliding-scale regimen and the weight-based protocol.

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Health Care System, Boston University, and Stanford said, or perhaps even for direct subcutaneous injection, in University, the study is significant for the way in which it uses order to stimulate the secretion of endogenous insulin – but the VA’s electronic health records to identify potential sub- no studies of such applications have yet been proposed. jects, randomly assign them one of the treatment regimens, and report outcomes in real time.

Learning – and Unlearning – Methods of Care One of the most exciting recent breakthroughs in diabetes treatment research, involving cell therapy, was achieved by One of the most important outcome determinants for an international team including researchers from Germany, diabetic patients is the way in which health care is orgaIsrael, the United Kingdom, and VA investigators at the nized, administered, and delivered. VA’s Health Services Miami VAMC led by 1977 Nobel Laureate Dr. Andrew Research and Development (HSR&D) Service and its Quality Schally. Publishing in the online Proceedings of the National Enhancement Research Initiative (QUERI) conduct and fund Academy of Sciences last fall, the team reported that it had research devoted to improving access to and quality of care. devised a way to transplant healthy beta cells – the pancreA newer approach to treating diabetic veterans is group atic cells that store and release insulin – into a human body treatment or shared medical appointments, which has without the usual risk of rejection. The development has pro- been shown to benefit patients with similar medical issues. found implications for the treatment of type 1 diabetes, the According to William Yancy, associate professor of medicine form of the disease caused by autoimat Duke University and senior investimune destruction of beta cells. gator for the Center for Health Services In the “artificial pancreas” develResearch in Primary Care at the oped by Israeli researchers, explained Durham VAMC, teaching more than ■■ A newer Dr. Zafar Iqbal, the portfolio manone patient at a time how to manage ager for VA’s Diabetes Research prodiabetes has proven more efficient, and approach to treating gram, donor beta cells “are packed in allowed a multidisciplinary team of diabetic veterans a gel that seals them from attack by specialists – a physician, PA, or nurse is group treatment the host’s immune system. The whole practitioner, perhaps accompanied by assembly is housed in a biocompata behaviorist or dietician – to deliver or shared medical ible plastic shell, and the chamber, care, rather than an individual. The appointments, which is about 2.5 inches in diameter approach has also benefited patients. which has been “You still are able to monitor their disand a half-inch thick, can be surgiease individually with very brief onecally implanted and linked to ports shown to benefit on-one sessions,” he said. “You can that the patient himself can use to patients with similar adjust their medications if needed. inject fresh oxygen, until new blood medical issues.

And they also benefit from the social vessels develop around the graft.” The support they receive – not only from 63-year-old patient who was given the the members of the team involved in implant was followed for 10 months, delivering the treatments, but also without taking any drugs for immufrom each other.” nosuppression, after which the artifiAt the Durham VAMC, Yancy said, researchers are evalucial pancreas was removed.

The Miami VA team played a crucial role in developing ating a refinement to this group treatment approach, comand testing the system in animal models, said Iqbal. Using bining diabetes education with weight-management counartificial compounds that mimic growth hormone-releasing seling. “Those two problems go hand in hand,” he said, “but hormone (GHRH), they found they could increase both typically the group visits, in the past, have not really impacted the viability of transplanted beta cells and their ability to the patients’ weight. So we’re trying to combine an intensive make insulin. “Using this knowledge,” he said, “they have weight-management program with the medical group visits. shown recently the stimulatory effect of new chemical com- Now we’ll see how that works.”

Dr. David Aron, associate director of the VA’s QUERI pounds they designed themselves, GHRH agonists, which enhance the production of insulin. These pancreatic cells Center for Implementation Practice and Research Support at were treated in vitro with GHRH agonists and then trans- the Cleveland VAMC, has been participating in group care planted into mice with diabetic symptoms. They’ve found for eight years, and says studies continue to provide evidence that this treatment of diabetic mice with GHRH agonists that they remain a useful tool both for glycemic control and normalizes glucose levels, in contrast to untreated mice in for broadening the expertise applied to individual patients.

Another method for bringing the knowledge of diabetes spewhich the glucose levels are very high.”

The discovery suggests the potential for using these ago- cialists to primary care doctors, currently being evaluated nists in a future version of the bioartificial pancreas, Iqbal jointly by HSR&D/QUERI and the VA’s Office of Specialty

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The Year in Veterans affairs & military medicine

photo by kelie burdette mendonca, public affairs specialist, sf vamc

■■ The Department of Veterans Affairs’ SCAN-ECHO teleconferencing program is being evaluated as a means of conducting consultations with diabetic patients.

Care Transformation, is the use of the agency’s teleconferencing program, SCAN-ECHO, to conduct consultations through a patient’s electronic medical record.

The Cleveland VAMC is one of the centers simultaneously rolling out and studying the diabetes SCAN-ECHO, said Aron. “This is an example of research and operations informing each other,” he said. “Research can be adjusted to meet the operations needs, and operations can be adjusted based on the research findings. This kind of partnered research has become of great interest to VA HSR&D.” When research and interprofessional clinical care are conducted alongside each other, informing real-time adjustments, the knowledge base evolves rapidly. In some settings, said Aron, clinical practice is slow to catch up. “I think one of the most critical research questions, in medical practice in general and in diabetes specifically, is: How do you stop doing what was previously accepted as correct, when it is shown no longer to be correct?”

For example, the clinical care guidelines developed by the VA and other organizations have, for more than 15 years, emphasized the importance of establishing individualized targets for glycemic control – and yet research led by Aron and Pogach has revealed many practitioners continuing to

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work with a fixed target, in the common A1c blood test, of less than 7 percent glycated hemoglobin. This target isn’t appropriate for many patients, such as those at risk for low blood sugar. “[Seven percent] has been the mantra for many years,” Aron said, “but for many patients, that degree of glycemic control is not appropriate. It will provide little, if any, benefit, but comes with risks.”

Based on the findings of Aron, Pogach, and others, the VA and the Department of Health and Human Services (HHS) will soon roll out a nationwide Hypoglycemia Safety Initiative to encourage individualized targets for glycemic control.

Aron has been funded to evaluate the efficacy of the initiative. “There will be a number of research questions coming out of that,” he said. “Specifically, how do you get people to de-implement outdated practices?”

In terms of the number of patients who have a stake in such questions, there may be no more important research program at the VA than the portfolio of studies designed to attack diabetes, prevent it from occurring, and optimize the care delivered to diabetic veterans. VA investigators and clinicians are helping lead the way in learning which interventions will optimize outcomes for these patients – and, if necessary, in unlearning those that won’t. n 45

â– â– Joseph Ambrose, an 86-year-old World War I veteran, attends the dedication day parade for the Vietnam Veterans Memorial in 1982. He is holding the flag that covered the casket of his son, who was killed in the Korean War. Armstice Day, established to honor those like Ambrose who fought in World War I, became Veterans Day in 1954, honoring all those who have served.

Mickey Sanborn

The Year in Veterans affairs & military medicine

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The Year in Veterans affairs & military medicine

The History of Veterans Day

By Dwight Jon Zimmerman H H H

“NOW, THEREFORE, I, DWIGHT D. EISENHOWER, President of the United States of America, do hereby call upon all of our citizens to observe Thursday, November 11, 1954, as Veterans Day. On that day let us solemnly remember the sacrifices of all those who fought so valiantly, on the seas, in the air, and on foreign shores, to preserve our heritage of freedom, and let us reconsecrate ourselves to the task of promoting an enduring peace so that their efforts shall not have been in vain.” – President Dwight D. Eisenhower, Oct. 11, 1954

H On March 15, 2011, following a ceremony in which his coffin lay in state in Arlington National Cemetery’s Memorial Amphitheater, former Army Cpl. Frank Woodruff Buckles was buried with full military honors. The last living American veteran from World War I had died at 110 years old.

Veterans Day is one of two federal holidays specifically designated to honor the men and women of our nation who served in uniform. Memorial Day, whose origins reach back to the Civil War, honors the fallen. Veterans Day was originally celebrated as Armistice Day and only honored both the living and dead from World War I. In 1954, legislation was signed changing its name to Veterans Day and to honor all veterans living and dead.

Originally World War I was called the Great War. Its consequences had been so horrific and devastating that world leaders called it “the war to end all wars” because they were certain a conflict of such magnitude could not happen again.

Field Marshal Ferdinand Foch, supreme commander of Allied Forces in Europe in the final months of the war, was not among them. Referring to the Versailles Treaty signed on June 28, 1919, that ended the Great War, he declared, “This is not a peace. It is an armistice for 20 years.” Ignored at the time, his prediction would prove startlingly accurate.

But government leaders in 1919 focused their thoughts on a more immediate date, the upcoming first anniversary of the signing of the armistice that had silenced the guns “on the eleventh hour of the eleventh day of the eleventh month” in 1918. Though in poor health as a result of a stroke suffered in early October, on Nov. 11, 1919, President Woodrow Wilson issued a 291-word proclamation calling upon the American people to celebrate the cause of freedom for which American troops had fought. His proclamation stated, “To us in

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America, the reflections of Armistice Day will be filled with solemn pride in the heroism of those who died in the country’s service and with gratitude for the victory, both because of the thing from which it has freed us and because of the opportunity it has given America to show her sympathy with peace and justice in the councils of the nations.”

Wilson suggested that citizens hold parades and that companies have “a brief suspension of business” at 11:00 a.m., which many across the country did, stopping work for two minutes.

Though Wilson intended Armistice Day to be a one-time-only observance, many states, with the endorsement of veterans organizations, chose to make Armistice Day an annual event.

The second anniversary in 1920 saw a huge outpouring of organized activities. New York City’s celebrations were typical. They included speeches from dignitaries; memorial masses and services; parades; the unveiling of a Great War memorial in Cypress Hills National Cemetery erected by the France-America Society honoring French sailors (the first of several Great War monuments erected throughout the city); the planting of memorial trees; high school pageants; and medal presentations, including one at the Brooklyn Navy Yard where a number of sailors received the Navy Cross. A variety of dances were staged, the largest being a charity ball held at the 23rd Regiment Armory in Brooklyn that included a concert, reception, and dance attended by 6,000 luminaries.

Representative of the speeches was that of F.W. Galbraith, Jr., national commander of the American Legion, who was the charity ball’s guest of honor. Organized in May 1919, the American Legion had been instrumental in Armistice Day’s creation and continued observance. In his speech, Galbraith called on Americans to “renew each year our vows of fealty, 47

The Year in Veterans affairs & military medicine

Library of Congress photos

■■ ABOVE: Burial of the unknown soldier at Arlington National Cemetery, Viginia, with President Warren G. Harding standing beside the casket, Nov. 11, 1921. RIGHT: President Woodrow Wilson and Ellen Wilson participate in Armistice Day festivities in 1919.

repledge and keep unshakeable our faith in the high ideals, in all continents will join.” This was followed by a speech the lofty purposes, the unselfish aspirations, and exalted by President Warren G. Harding dedicating the Tomb of holy hopes that fired the hearts of Americans in 1918 and the Unknown, singing by a quartet from the Metropolitan made ours a land whence crusaders came, with souls aflame, Opera Company, a bugler playing “Taps”, and the playing worthy of their victory.” of a band. It was the first such event to be broadcast live In Washington, Wilson got out of his sickbed and watched nationwide over the radio. the observances in Lafayette Park, including the moment of Harding’s speech elevated the anonymity of the serviceman silence and an artillery salute, from his bedroom window. in the tomb, making him a symbol of dedication and sacrifice On the morning of March 4, 1921, his last official day in America sometimes asks of its citizens to defend and uphold its office, Wilson added another ceremony to commemorate principles. With former President Wilson watching, Harding Armistice Day by signing legislation establishing a Tomb of stated, “We are met today to pay the impersonal tribute. The the Unknown at Arlington National Cemetery. Stone for the name of him whose body lies before us took flight with his tomb was Yule Marble obtained from a quarry near Marble, imperishable soul. We know not whence he came, but only Colorado. Famous for its exceptional, that his death marks him with the everpure quality, it was the same marble used lasting glory of an American dying for ■■ “On such an on the exterior of the Lincoln Memorial. his country. ...” occasion as this ... our The remains of an unknown American “On such an occasion as this ... our thoughts alternate serviceman buried in France were thoughts alternate between defenders exhumed and shipped to Washington, living and defenders dead. A grateful between defenders where his flag-draped black coffin rested Republic will be worthy of them both. living and defenders in state in the Capitol Rotunda until Nov. Our part is to atone for the losses of dead. A grateful 10, 1921. An estimated 90,000 people heroic dead by making a better Republic paid their respects, forcing officials to Republic will be worthy for the living.” He closed his speech by keep the Capitol open until midnight. calling on everyone to join him in the of them both. …”

By 1921, nationwide observance had recitation of the Lord’s Prayer. elevated Armistice Day to the point of it In 1938, 20 years after the end of the being an unofficial national holiday. In addition to speeches, Great War, Congress passed legislation making Armistice parades, monument dedications, and other events, Wall Day a federal holiday. During the debate over the legislation, Street announced it would be closed. But the most impor- Rep. Bertrand W. Gearhart, R-Calif., suggested the day “not tant event held on Armistice Day’s third anniversary was the be devoted to the exaltation of glories achieved in war but, dedication of the Tomb of the Unknown. rather, to an emphasis upon those blessings which are assoReferred to by The New York Times as “a unique program,” ciated with the peacetime activities of mankind.” With the the commemoration at Arlington National Cemetery called storm clouds of war gathering in Europe, and conflict already for a nationwide observance of two minutes of silent prayer happening in Asia, he hoped that Armistice Day would to begin at noon Eastern Standard Time “for the dead of become a holiday that not only marked the “end of a great the war and for future peace, a prayer in which millions war,” but also the beginning “of a new era of peace.”

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Library of Congress photo

■■ President Franklin D. Roosevelt speaking on Armistice Day at Arlington National Cemetery.

But on Nov. 11, 1941, with Europe and Asia at war and America’s involvement more a matter of “when” rather than “if,” President Franklin D. Roosevelt used that year’s Armistice Day tribute at the Tomb of the Unknown to challenge a nation that had become complacent in its isolationism. In his address, Roosevelt said, “Observance of this anniversary has, I think, a particular significance in the year 1941.” He noted a recent meeting near the tomb that World War I Medal of Honor recipient Army Sgt. Alvin York had with some people who, in reference to fighting in World War I, said they asked him and other veterans who fought in it, “What did it get you?”

The president repeatedly used that question like a hammer striking an alarm.

“What did it get you?”

Roosevelt replied that the people who asked that question “forgot that the danger that threatened this country in 1917 was real, that the sacrifice of those who died averted that danger.” And, in forgetting, they took the security of our freedom for granted, asking why those who died to save that freedom should have died at all.

“What did it get you?”

He pointed out that had America lost in 1918, such a question would not be asked, for tyranny would be at the country’s shore, in its cities, and at people’s doors as it presently was in occupied Europe. He then said, “Sgt. York spoke thus of the cynics and the doubters: ‘The thing they forget is that liberty and freedom and democracy are so very precious that you do not fight to win them once and stop. You do not do that. Liberty and freedom and democracy are prizes awarded only to those peoples who fight to win them and then keep fighting eternally to hold them.’”

Roosevelt closed with an observation that Americans “believe that liberty is worth fighting for.” And he closed his remarks with the statement, “This duty we owe, not to ourselves alone, but to the many dead who died to gain our freedom for us – to make the world a place where freedom can live and grow into the ages.”

The guns of World War II had been silent less than three months when a Nov. 11, 1945, New York Times headline stated the thought on everyone’s mind: “Armistice Day of 1945 Brings Up Comparisons.” President Harry S Truman, himself a veteran of what was now called World War I, issued a proclamation calling on Americans to build “an enduring peace among the countries of the world.” Many wondered how it could happen. The article noted that, compared to 1919, world leaders had a “tougher job this time.” Though Armistice Day officially

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The Year in Veterans affairs & military medicine

■■ Above: Raymond Weeks petitions Gen. Dwight D. Eisenhower to establish a national Veterans Day at the Pentagon in 1946. Right: Eisenhower signs H.R. 7786, June 1, 1954. This ceremony changed Armistice Day to Veterans Day. Pictured from left to right, Alvin J. King, Wayne Richards, Arthur J. Connell, John T. Nation, Edward Rees, Richard L. Trombla, and Howard W. Watts look on.

1998, he was identified through DNA testing and returned to his next of kin for burial. All unknowns posthumously received the Medal of Honor. commemorated only the service and sacrifice of World War On Nov. 11, 1982, in a White House ceremony, President I veterans, 1945 ceremonies included veterans from both Ronald Reagan awarded Weeks, the “Father of Veterans Day,” world wars. with the Presidential Citizens Medal, the nation’s secondIn late 1945, World War II veteran Raymond Weeks peti- highest civilian award. In his remarks, Reagan said, “For more tioned Army Chief of Staff General of the Army Dwight than 50 years, Mr. Weeks has exemplified the finest tradiD. Eisenhower to change the name of Armistice Day, with tions of American voluntarism by his unselfish service to his its World War I association, to a more inclusive Veterans country. As director of the National Veterans Day Celebration Day that honored all veterans. in Birmingham for the past 36 He became a driving force to Raymond Weeks ... has ■■ “Veterans Day is very personal. years, that effect. On Nov. 11, 1947, devoted his life to serving others, his hometown of Birmingham, I tend to be by myself. I retreat his community, the American vetAlabama, staged the first into a place where I think about eran, and his nation.”

Veterans Day celebration, with On June 28, 1968, Congress the people I served with and who passed General of the Army Omar the Uniform Holiday Bill Bradley as its keynote speaker. never came back. And I shed tears to “provide for uniform annual Weeks’ continued efforts for them. It’s an attitude that observances of certain legal public gained growing support, and holidays on Mondays.” Instead of hasn’t changed over the years.” on June 1, 1954, Eisenhower Washington’s birthday being celsigned legislation that officially ebrated on Feb. 22, Memorial Day changed Armistice Day to Veterans Day, with a broadened on May 30, and Veterans Day on Nov. 11, the act set observances definition that paid “homage to all of its veterans.” of them to be the third Monday in February, last Monday in On Aug. 3, 1956, President Dwight D. Eisenhower signed a May, and the fourth Monday in October, respectively (the newly bill paying tribute to the unknowns from World War II and established Columbus Day holiday was also included in this the Korean War. In 1958, the remains of two World War II Monday law). By making them three-day weekends, Congress unknowns, one from the European Theater and one from the believed it increased the opportunities for families separated by Pacific Theater, and four unknowns from the Korean War distance to be together and to enjoy recreational activities. were exhumed and their caskets lay in state in the Capitol The first Veterans Day under the new law was celebrated Rotunda until May 30, 1958, when they were interred at on Oct. 25, 1971, under much confusion. Most states chose Arlington. A Vietnam War unknown was added in 1984. In to observe Veterans Day on Nov. 11, and it quickly became 52

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The Year in Veterans affairs & military medicine

U.S. Marines photo / U.S. Army Photo by Spc. Lance Philpot

■■ LEFT: The color guard from Special Purpose Marine Air Ground Task Force 26 marches in the New York City Veterans Day parade Nov. 11, 2009. ABOVE: Guests fill the Memorial Amphitheater in Arlington National Cemetery, Arlington, Virginia, in observance of Veterans Day, Nov. 11, 2012.

apparent that Nov. 11 held transcendent significance for a majority of citizens. On Sept. 20, 1975, President Gerald R. Ford signed into law a bill that restored observance of Veterans Day to Nov. 11.

The many public ceremonies held on Veterans Day are important. But for those who served and members of their families the day becomes personal, even private. James R. Lawson, a bar/restaurant owner from Manalapan, New Jersey, whose father served in the Army and fought in Vietnam, said that because of his father, Veterans Day always meant a lot.

Then his son James F. Lawson enlisted in the U.S. Navy in 2010, and after two years training in the Navy nuclear program was accepted at Annapolis, class of 2016. Lawson said his pride for his son is tempered with “concern knowing Jimmy could be going into harm’s way.” And of Veterans Day itself, Lawson said, “My attitude definitely changed in a drastic and more meaningful way.”

George Ryan, a retired printer from The New York Times, entered the Army in 1966 and was honorably discharged in 1968 with the rank of sergeant. He fought at Hue during the Tet Offensive and his decorations include the Purple Heart and Bronze Star. “Veterans Day is very personal,” he said. “I tend to be by myself. I retreat into a place where I think about the people I served with and who never came back. And I shed tears for them. It’s an attitude that hasn’t changed over the years.”

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Mike Wickes of Brooklyn, New York, enlisted into the Marine Corps in 1963 and was honorably discharged in 1969 with the rank of staff sergeant. During his service overseas he was attached to a Naval Security Group unit in Europe.

Veterans Day reminds him of those years when he wore the Marine uniform. Recalling that period, he said, “Some of my best friendships were formed in the Marine Corps.” He added that the bond is so deep that the only way to truly understand its depth is “to be in the service. I admire and respect all veterans.”

Donna McAleer (West Point, 1987) is the Democratic candidate for Congress in Utah’s 1st Congressional District. She was stationed in Germany during the fall of the Berlin Wall and collapse of the Soviet Union and served as an executive officer and later platoon leader. She was honorably discharged in 1991 with the rank of first lieutenant and remained in the Army Reserve until 2000. Prior to her service she said there was no standout memory when it came to Veterans Day. “Now,” she said, “Veterans Day is much more reflective for me. This day reminds us how important it is that the men and women who wear this country’s uniform know just how grateful their fellow Americans are for their service. Veterans come from all walks of life: They are parents, children, aunts, uncles, and grandparents. They are friends, neighbors, and coworkers. They are an important part of our communities.” n 53

The Year in Veterans affairs & military medicine

Opening Doors to Better Health Care VHA’s Office of Quality, Safety and Value

n Speaking before the 96th annual convention of the American Legion last August, VA Secretary Robert McDonald told attendees: “From here on out, we want veterans to know that when they walk through VA’s doors, employees are ‘all in’ when it comes to meeting our mission … ‘living’ our values … and keeping veterans first and foremost in all that they do. Without that, there can be no trust.”

As the VA’s lead program office for ensuring high quality, safe and reliable care that is centered on the veteran, the 54

Office of Quality, Safety and Value (QSV) has a particularly critical role to play in helping realize the secretary’s vision.

In the four years since our program office was established within the Veterans Health Administration (VHA), QSV has been working to ensure that VHA’s clinical and business processes are appropriately aligned; that its health care providers work collaboratively as high-functioning teams; and that VHA staff feel empowered to serve as “change agents” on behalf of veterans, families, and co-workers.

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Photo by Reynaldo Leal

By Dr. Robin Hemphill, Acting Assistant Deputy Under Secretary for Health for Quality, Safety and Value

VA photo

The Year in Veterans affairs & military medicine

To accomplish these goals, QSV brings together, under one umbrella, the functional areas that contribute toward making the totality of a veteran’s VHA experience outstanding and seamless. These areas include patient safety, systems redesign, accreditation standards, and utilization management, as well as business compliance and integrity.

What does this mean, in practical terms, for veterans who choose VHA as their health care provider? It means that from the moment veterans walk through those same facility doors to which the secretary referred, QSV is working across the VHA enterprise to assure the following: • That patient safety is the foundation upon which care is built, and that processes are in place to prevent errors and inadvertent harm to patients as a result of their care. While QSV as a program office is relatively new, it includes the department’s National Center for Patient Safety (NCPS), which was founded in 1999. NCPS brings together a multidisciplinary team of experts who work toward creating a “culture of safety.” A necessary precursor to, and component of this culture is the promotion of a “just culture” where employees are not punished for making errors and are encouraged to bring forth bad news before it causes harm to patients. Importantly, a just culture also means that appropriate accountability principles are made clear. Achieving these outcomes requires strong leadership and a commitment to support the work of high-functioning clinical teams. In other words, leadership fully understands that the best way for clinical staff to address complexity is through teamwork, and by working in an environment in which they can speak freely, address system harms, and hold each other to the highest standards, thereby making them better able to focus on priority number one: care of the patient. These cultural imperatives are closely aligned with what Secretary McDonald referred to as “living our values.”

• That each VA facility meets accepted standards of health care operation, such as those set by the Joint Commission that accredits and certifies more than 20,500 U.S. health care organizations and programs. All 151 VAMCs [VA medical centers] are accredited by the Joint Commission, and in November 2013, 32 were recognized as “top performers.” Notably, for several VAMCs, 2013 was not the first time they were recognized as top performers.

• That health care providers caring for veterans are appropriately licensed and credentialed. Such assurance is fundamental to the provision of safe, high quality care, and central to ensuring the integrity of the work force. For those who may be unfamiliar with what this process involves, it is important to understand that credentialing and privileging is a peer review process that takes place during the appointment, or reappointment of health care providers, and includes review of health care providers’ education, training, licensure, certification experience, and competency. Through its Medical Affairs Staff Division, QSV works to ensure that all VHA individuals who are permitted by law

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and the facility (in which they practice) to provide patient care services independently are credentialed and privileged.

• That health care claims are processed efficiently, and in compliance with regulations governing business practices. While many may not associate this assurance with the delivery of clinical care per se, it is important to keep in mind that such oversight ensures the appropriate use of public funds and resources specifically designated for veterans’ care. QSV’s Office of Compliance and Business Integrity (CBI) relies on a complex administrative and financial system that processes billions of dollars annually in the delivery of care to veterans.

On a daily basis, CBI – through its network of compliance officers and staff located throughout the VHA system, consolidated patient account centers, and other administrative units – works with veterans and their families, as well as VHA employees, to identify and help remediate instances of noncompliant business practices.

• That, above all, veterans receive the right care at the right time in the right setting for the right reason. In other words, “keeping veterans first and foremost” in all that we do, as Secretary McDonald stated, is QSV’s top priority.

The above examples provide only a snapshot of the wide array of programs and activities that fall under QSV’s domain.

And while our charge is formidable, we are uniquely positioned to support these programs and functions for two reasons: our role as a “learning laboratory” and our numerous partnerships with internal and external collaborators.

■■ Opposite: VA Secretary Robert McDonald made his first visit as secretary to the Phoenix VA Medical Center (VAMC), where he met with veterans and employees. On Aug. 9, 2014, he addressed the Disabled American Veterans National Convention and spoke about his experience, the veterans and employees he met, and his vision for VA. He also visited the Las Vegas VAMC during the trip. ABOVE: A doctor uses a stethoscope to listen to the heart of a Vietnam veteran. QSV works to ensure that patient safety is the foundation upon which care is built.

55

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The Vest® is a registered trademark of Hill-Rom Services PTE Ltd. Enhancing Outcomes for Patients and Their Caregivers is a registered trademark of Hill-Rom Services, Inc. The Vest System is offered in the home by Advanced Respiratory, Inc, a Hill-Rom company. Hill-Rom reserves the right to make changes without notice in design, specifications and models. The only warranty Hill-Rom makes is the express written warranty extended on sale or rental of its products. © 2014 Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED.

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The Year in Veterans affairs & military medicine

■■ Staff at the Muskogee VA Regional Processing Office. QSV’s Office of Compliance and Business works with veterans, their families, and VHA employees to ensure health claims are processed efficiently and in compliance with business practices.

team functioning and patient flow, QSV has partnered with the primary care office on a variety of initiatives.

Promoting industry standard practices: QSV’s several diviIn many respects, formation of the QSV office in 2011 reflected VHA’s recognition that new approaches were sions and programs are steeped in innovation and new busineeded to manage an increasingly complex health care envi- ness improvement processes such as Lean (the latter being a ronment. Like the private sector, VHA faces the challenge of process developed by the Japanese automotive industry that is preventing, treating, and managing the health care needs of being adapted to improve health care quality and efficiency). a patient population that is living longer and includes more Throughout VHA facilities, Lean strategies have been used individuals coping with chronic disease and other complex to improve the care of veterans through hundreds of rapid health care issues. Further, veterans as a population group improvement projects that impact care from the smallest areas all the way to the system level. experience a set of health challenges that Another set of examples stems are unique to them (e.g., polytrauma) from QSV’s recent initiatives to and VHA must ensure their specific ■■ QSV’s wide focus intensively on standardizing needs are met. Responding effectively to array of programs the processes and equipment used these issues requires a framework that requires extensive in the sterile processing of reusable supports new models of care, promotes medical equipment (e.g., forceps, new principles of business practice, and collaboration across endoscopes) throughout VHA medprovides resources to facilitate continthe VHA enterprise, uous learning. ical facilities. QSV, through its ISO as well as with Utilizing new models of care: Through Consultation Division (ICD) has its Patient Aligned Care Teams (PACT) distributed $50 million to facilities federal government model, VHA is committed to ensuring to lease or purchase updated, stanpartners and the that each veteran is followed by a team of dardized equipment used in sterile private sector. providers who knows his or her unique processing. Additionally, each piece health care needs. To help improve PACT of reusable equipment is required to

VA photo

QSV as “Learning Laboratory”

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undergo precise, step-by-step cleaning as specified by the being expanded to enable a wider variety of VHA profesequipment’s manufacturer. However, frequent changes in sionals to obtain core knowledge in patient safety.

Importantly, the National Center for Patient Safety has manufacturers’ instructions, as well as staff turnover, create opportunity for error. In response, to provide the standard- a long-standing partnership with the Office of Academic ized business processes that support work in sterile pro- Affiliations (OAA) to ensure that future generations of phycessing. ICD launched the build of an ISO 9001 consistent sicians have enhanced skills in Quality and Safety, and has developed a Chief Resident in Quality and Safety Program Business/Quality Management System.

Supporting new learning: As part of its charter, QSV is (CRQS). In the six years since the program was founded, the charged with promoting and supporting a culture of contin- program has expanded from a single site in Indianapolis to 45 VAMCs, and has become a pipeuous learning. Each of our five work line for developing quality improvestreams (CBI, Quality Standards and Programs, High Reliability Systems ment/patient safety [QI/PS] leaders ■■ As part of its and teachers. Chief residents who and Consultation, Healthcare Value, charter, QSV is charged enroll in this patient safety program Patient Safety and Risk Awareness) with promoting and become “change agents” who spur sponsors numerous classes, webidialogue about quality improvement nars, and other learning opportunisupporting a culture of and safety nationwide. ties for VHA employees to stay curcontinuous learning. rent in their respective disciplines and become more knowledgeable QSV: The Collaborator’s about related fields.

Collaborator Every summer, for example, QSV’s Risk Management Program holds a “boot camp” designed primarily for recently QSV’s wide array of programs requires extensive collaboraassigned risk managers who have been in their positions less tion across the VHA enterprise, as well as with federal governthan two years. The week-long session covers risk management ment partners and the private sector. functions and includes topics such as “Peer Review for Quality As part of the nation’s largest integrated health care Management” and “Disclosure of Adverse Events to Patients.” system, QSV works closely with doctors, nurses, quality Similarly, other long-standing programs exist to ensure managers, risk managers, and patient safety managers across that all patient safety managers are trained in core compe- the entire VHA system. At the program office level, in additencies through Patient Safety 101. Today, this program is tion to OAA, we work closely with the National Center for 58

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va photo by Reynaldo Leal

■■ VA Secretary Robert McDonald speaks with a medical professional during a visit to the Phoenix VA Medical Center. QSV is determined to ensure veterans are provided the right care at the right time in the right setting for the right reason.

The Year in Veterans affairs & military medicine

Ethics in Healthcare (with whom we co-sponsor the annual National Ethics and Compliance Week), the Office of Patient Care Services, the Office of Public Health, and the Office of Information and Analytics, among others.

We are also partnered with VHA’s Office of Research and Development (ORD), which itself sponsors a number of studies and programs related to health care quality and patient safety. One such program is ORD’s Center of Innovation in Quality, Effectiveness and Safety (IQuESt).

Based in Houston, the center’s goal is to improve quality, effectiveness, and safety of health care through patient-centered coordination and communications.

We also work with numerous federal government agencies, including the Department of Defense (DOD). Since the early 1990s, we’ve teamed with DOD (and other leading professional organizations) in the development of evidence-based clinical practice guidelines (CPGs) specifically geared toward veterans’ health concerns, e.g., chronic disease (diabetes, chronic heart failure), mental health (PTSD, substance use disorder) and postdeployment health. CPGs may help reduce variation in practice and promote consistent quality of care. As this article goes to press, two new guidelines have been announced: one regarding non-surgical management of hip and knee osteoarthritis and one about the management of upper extremity amputation.

Other federal collaborators include the Government Accountability Office, and within the Department of Health and Human Services (HHS), the Agency for Healthcare Research and Quality, and Centers for Medicare and Medicaid Services. VHA has been an active partner in the HHS-sponsored Partnership for Patients, which has worked to increase nationwide awareness about hospitalacquired conditions. Lessons learned from VHA research and improvement efforts have been widely shared with the Partnership for Patients Program.

Finally, QSV is the VHA lead for the Million Hearts® initiative, a multi-federal agency program (led by the Centers for Disease Control and Prevention) which aims to prevent one million heart attacks and strokes over five years. Here, we’ve been working with VHA program offices and health care providers to promote the initiative. Notably, VA was recently recognized as a Million Hearts Hypertension Champion.

Conclusion

In both history and literature, the word “door” is often used to suggest, foreshadow or symbolize some type of transformation. At QSV, we’re working to ensure that every VA facility door leads to better health care for all the nation’s veterans.

By empowering VHA employees to serve as change agents, promoting a just culture and culture of safety, ensuring highfunctioning teams, serving as a learning lab, and partnering with numerous entities, QSV is “all in,” to use the secretary’s words, in meeting VA’s mission. To learn more about QSV, visit www.qualityandsafety.va.gov. n

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QSV Resources for Veterans • Compliance and Business Integrity (CBI) Helpline: By calling this toll-free number, veterans and their family members can report concerns regarding payment processing, billing creation, and similar business compliance concerns. 1-888-842-4357.

• Quality of Care website: Developed in partnership with veterans, this website discusses patientcentered care, ways the VA is working to improve quality, and how veterans can partner with their VA provider to receive the best care possible. www.va.gov/QUALITYOFCARE/about.asp • Patient Safety Resources for Veterans: This website includes information on how veterans can become more closely involved in their care, and partner with their provider; also includes several sets of safety tips. www.patientsafety. va.gov/veterans/index.asp

On April 25, 2011, Dr. Robin Hemphill joined VHA as the Chief Safety and Risk Awareness Officer and Director, National Center for Patient Safety. She continues to practice as an emergency medicine physician.

A graduate of George Washington University Medical School, she completed an internship in internal medicine followed by emergency medicine at the Joint Military Medical Centers in San Antonio, Texas, and served on active duty as an attending physician at Brooke Army Medical Center, where she was the director of risk management and the assistant residency director.

After the completion of her military obligation she joined the faculty at Vanderbilt University in the Department of Emergency Medicine as the Associate Program Director. She was also the Medical Director for the Tennessee State HRSA Hospital Bioterrorism Preparedness Program as well as for the National Center for Emergency Preparedness at Vanderbilt.

She was also involved in local planning and preparedness issues for the City of Nashville and was the Medical Director for the developing Nashville Urban Search and Rescue Team.

During this time she was also the President of the Tennessee College of Emergency Physicians. While at Vanderbilt she completed a Masters in Public Health with a focus on syndromic surveillance.

She moved from Vanderbilt to Emory University to be the Director of Quality and Safety for the Department of Emergency Medicine there, from whence she came to the VHA. 59

The Year in Veterans affairs & military medicine

Blood: The Greatest Gift of the Greatest Generation During World War II, plasma saved lives.

By Anastasia Kirby Lundquist

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The Year in Veterans affairs & military medicine

photos courtesy of anastasia Kirby Lundquist, unless otherwise noted

A radio show called Life to the Front, broadcast weekly over WEEI, the Columbia Broadcasting System’s New England network outlet in Boston, helped keep alive the connection between the home front and the fighting fronts to encourage blood donations. Each week the broadcast was dedicated “To all the men of the armed forces of the United States ... who – on every fighting front in the world – daily risk their lives in the service of their country … that they might live.”

The program was co-produced by Anastasia Kirby of the Boston Blood Donor center and Lt. Henry Lundquist of the First Naval District. On June 11, 1944, they were married.

She tells her story in a new book, Out for Blood: The Pursuit of Life for the Wounded on the Fighting Fronts of World War II, available on Amazon, a portion of which is excerpted here.

n Much has been written about the greatest stoic about this grim statistic when he wrote generation, but not about its greatest gift. from the Pacific, “The Pacific War, though While the people at home contributed to thousands of miles away from the shores of war bond drives, raised victory gardens, the United States, is daily brought directly and collected scrap metal for the war into many American homes by formal notieffort, the most intimate gift all, a perfication of the injury or supreme sacrifice of son’s own blood, was often the gift of life a member of the family. There is nothing for many a casualty. These gifts were given that anyone can do to prevent altogether through the wartime American Red Cross the tremendous cost of war.”

Blood Donor Service for the exclusive use The survival rate among those who were of the surgeons general of the Army and not killed outright, however, was far greater Navy wherever needed. than anyone might have thought possible.

The majority of the blood taken was It was estimated that ninety-six survived sent to a laboratory for processing into out of every one hundred wounded. Maj. plasma, then shipped wherever the Army Gen. Norman T. Kirk, surgeon general of and Navy directed. Eventually, the blood the Army, presented three reasons for this ■■ Opposite: This broadcast of many type O donors was flown as whole when he addressed the American Medical of Life to the Front took place blood directly to Europe by the Army’s Air Association [AMA] House of Delegates in from the studios of WEEI in Transport Command and, after V-E Day Chicago on June 7, 1943.

Boston. Lt. Henry Lundquist is next to the microphone; [victory in Europe], to the Pacific by Naval “The foremost lifesaver,” the general Anastasia Kirby is at the far Air Transport Service – or NATS – planes. declared, “is plasma, the dried blood extract right. ABOVE: Out for Blood, From the beginning, plasma – and later which millions of Americans have been a newly published book by whole blood – was credited by the surgeons giving the Red Cross for nearly two years.

Anastasia Kirby Lundquist. general of the Army and Navy as being the Plasma saved shock and bleeding, and greatest lifesaver of World War II. without that many men would have died The generosity of these donors can be before they could have reached medical care. traced for generations into the future. They Second in lifesaving was surgery, which were indeed part of a great romance, and their children are, cleaned up the wounds to reduce risk of infection. In third too, because many of these children are alive today because place were the sulfa drugs, aiding to minimize infection.” the life of a father or grandfather was saved by the blood of The AMA had always received good press coverage of its one of these donors. meetings. After all, it was the foremost authority on matSixteen million Americans served in uniform in World ters medical, so something of significance was expected War II. The death toll was just over four hundred thousand, when they met. Announcement of their speaker for that of which nearly three hundred thousand were battle fatali- June event brought greater interest than ever. With the war ties. Chief of Naval Operations Fleet Adm. Ernest J. King was raging throughout the world and Kirk just back from the

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The Year in Veterans affairs & military medicine

■■ WEEI broadcast live from the Boston Blood Donor Center while the station’s radio personalities gave blood.

African front, the media turned out in record numbers.

They were so impressed that many of them carried the general’s speech in its entirety.

The Nov. 17, 1943, report of the Office of War Information contained further evidence of the value of plasma and therefore the importance of our donors. This was their first comprehensive survey of the care of war wounded. It was filled with facts and figures. Among the variety of impressive statistics was the following: “The main reason for saving wounded was: 1. Use of blood plasma to combat shock and hemorrhage.

2. Use of sulfa drugs to combat infection.

3. Quality of medical services which insure prompt treatment.”

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The survey explained, “Faster treatments and improved Army-Navy Methods for attending the wounded are playing a major role in reducing the number of deaths from wounds.”

They further noted, “In the last war, we brought the wounded to the hospital; in this war, we are bringing the hospitals to the wounded.”

Sometimes the hospital brought to the front would be nothing more than a tarp thrown over the trees. Ernie Pyle, the noted war correspondent who wrote for the ScrippsHoward newspapers – with a readership of more than 122 million in 310 cities – followed the war. The folks at home eagerly awaited his columns.

Pyle was hospitalized for a while, but never stopped working. From his cot in the corner, he wrote about what he saw and what he heard.

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The Year in Veterans affairs & military medicine

■■ The donor meets the recipient. Mrs. Audrey Woodward and Richard Harvey with Joseph Hamlin, the chairman of the Metropolitan Boston Chapter of the Red Cross. This photo was published in the Holtzer Cabot company newspaper, where Woodward worked as a secretary in the accounting department.

“The doctors asked me at least a dozen times to write about plasma,” said Pyle. “They say that plasma is absolutely magical. ‘Write lots about it, go clear overboard for it, say that plasma is the outstanding medical discovery of the war.’”

Radio became a way for the public to meet and hear those who had been on the front lines, receiving or watching our donors’ blood at work. Listeners heard a frontline story from

there to get first aid and dry clothes, having just been picked up out of the water after the sinking of the Northampton.

The chaplain was being put ashore to die.

The Minneapolis, like the Northampton, had been hit by a Japanese Long Lance torpedo. Although not sunk, the Minneapolis was severely damaged, its bow blown off back to its forward gun turret, the ship engulfed in flames and smoke. The chaplain had been caught in the fire and critically burned. He was helped into sick bay and immediately given a unit of blood plasma … but little hope of survival.

The medics decided to get him off the ship to the nearby island of Tulagi where a medical evacuation center had been set up. They wrapped him in yards and yards of gauze bandage and lowered him over the side of the Minneapolis into a Higgins boat for the trip ashore. He went alone, because no corpsman could be spared to accompany him. There were too many casualties aboard in need of critical care.

■■ Radio became a way for the public to meet and hear those who had been

on the front lines, receiving or watching our donors’ blood at work. Listeners heard a frontline story from someone who was there, and it seemed personal. They felt they knew the person, and they were deeply moved – in many cases, moved to become blood donors.

someone who was there, and it seemed personal. They felt they knew the person, and they were deeply moved – in many cases, moved to become blood donors.

Our radio program, Life to the Front, became a powerful way to tell those stories – like this story, that starts a half a world away from Boston.

On Dec. 1, 1942, two men in the U.S. Navy met for the first time in a Higgins boat on the sea off Lunga Point in the Solomon Islands. One was a lieutenant in the Chaplain Corps; the other was a boatswain’s mate second class. They had just left their respective ships, the heavy cruisers Minneapolis and Northampton. The two men and their ships had taken part in an important event, the Battle of Tassafaronga, named for a point on the coast of Guadalcanal.

The two were among others on their way to the island of Tulagi. The boatswain’s mate went

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On the way, the boat crew came upon the boatswain’s mate clinging to a powder can. They picked him up and took him along with them. When they landed, they hurried the chaplain into the emergency unit, where he was immediately given another unit of plasma.

■■ WEEI CBS Life to the Front ticket.

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The Year in Veterans affairs & military medicine

“They evacuated me to a hospital in Auckland, New The boatswain’s mate watched and listened. The man he saw on the Higgins boat lying on a cot was wrapped in his ban- Zealand, and I was there for quite a while. I was blind for two dages like a mummy, with still another plasma tube running weeks; I couldn’t walk for two months.”

“But I see that our boatswain’s mate here is wearing a down into his arm and the doctors shaking their heads. The sailor knew he would never forget the chaplain, but he was Silver Star ribbon,” McQuaid said. “You don’t get that for perfect attendance.” also sure he would never see him again.

A copy of the citation for his medal had been given to me Eight months later and eight thousand miles from the Solomons, Chaplain Arthur F. McQuaid and Boatswain’s for the interview.

“After his ship had been badly damaged by a torpedo hit Mate Second Class Julius R. Mays sat around the microphone in the studio of the Columbia Broadcasting System’s New and set on fire, Mays, although menaced by terrific heat and England outlet, WEEI in Boston, for the opening program bursting ammunition from the boat deck, twice climbed the flame-enveloped structure of of the new radio series, Life to the the main mast and assisted in evacFront, that would begin on July 15, uating wounded personnel who 1943, and run the length of the war.

■■ “What a small world,” had been injured by an explosion As I introduced my two guests to I noted, “when you think and blinded by oil and smoke. His the radio audience and described of blood going out from their trip to Tulagi, Julius Mays was heroic conduct was in keeping with shaking his head: “I can’t believe the highest traditions of the United the United States all the you’re here, Padre. I can’t believe States Navy. Signed, Frank Knox, way to the Pacific and it’s you. It seems like a miracle.

Secretary of the Navy.” coming back to Boston in Where did you go from Tulagi?”

“Can you fill in the details, Mays?”

Mays asked the chaplain. asked the chaplain. the chaplain’s veins.”

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National Archives

■■ Private Roy W. Humphrey of Toledo, Ohio, is given blood plasma after he was wounded by shrapnel in Sicily on Aug. 9, 1943.

The Year in Veterans affairs & military medicine

■■ Navy Chaplain Lt. Cmdr. Arthur McQuaid was critically burned during the Battle of Lunga Point off Guadalcanal. He was saved by plasma.

“Well, my battle station was battle telephone talker in the damage control party. After we got hit, we were so badly off, there wasn’t much a damage control party could do. So when a call came to get some morphine up to some wounded men on the main mast, I ran and got it and went up and gave it to the fellows who needed it most. One had both legs broken by the concussion, and he was hurting so much that he would rather stay where he was than be moved after I brought him down.”

“And then what?” asked the Padre.

“Well, I tied a couple of lifebelts around him and pulled him to where the water would float him off when the ship rolled over.”

“Did it work?” I asked.

“Yes, ma’am, it worked. When the Northampton rolled over, the wounded man floated clear.”

“And that’s not all, according to my information,” I added.

“Well, we brought two other wounded down from the mast … at least they say I did. I don’t remember coming down from the second trip, but I must have, because I had gotten a powder can from somewhere and was floating around on it. Then I was picked up by the same boat that had taken the chaplain here off his ship, and it took us both to Tulagi.”

“What a wonderful sense of satisfaction that must be for you, Mays,” said the chaplain.

“It is, sir. But what a wonderful satisfaction it must be for blood donors in Boston to see you back home alive because of plasma.”

“What a small world,” I noted, “when you think of blood going out from the United States all the way to the Pacific and coming back to Boston in the chaplain’s veins.”

Life to the Front was off to a great start, and the chaplain returned to active duty soon after.

McQuaid had another “small world” experience on New Year’s Day 1944, when he was about to say mass in a little chapel on the base at Lakehurt, New Jersey. He needed an altar boy, so he asked for a volunteer from his congregation.

A young Marine came forward and served.

After mass, as the priest was removing his vestments, his altar boy said, “You weren’t here last New Year’s Day, were you, Father?”

“No,” said the Padre, “I wasn’t.”

“I bet you a dollar I know where you were.”

“All right,” replied the priest, pulling out a dollar bill and laying it on the table. “Where?”

“You were in the hospital in Auckland, New Zealand.”

“How did you know?”

“You were in the bed next to mine.”

The chaplain pushed the dollar bill toward the Marine. n

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The Year in Veterans affairs & military medicine

Air Force Dental Service A History of High-flying Dental Care

By Dwight Jon Zimmerman

n The National Security Act of 1947 reorganized America’s military under a single Cabinet-level post, the Department of Defense, and formally elevated the Air Force, formerly a part of the Army, as a separate branch equal to that of the Army and Navy. Two years later, on June 8, 1949, Air Force Chief of Staff Gen. Hoyt S. Vandenberg signed Order No. 35 creating the Air Force Medical Service, commanded by an Air Force surgeon general and consisting of six divisions: the Medical Corps, Dental Corps, Veterinary Corps, Medical Service Corps, Nurse Corps, and Women’s Medical Specialist Corps. Almost a month later, on July 1, the Joint Army and Air Force Adjustment Regulation No. 1-11-62 of May 1949 officially transferred the first cadre of 160 dentists from the Army to the Air Force. Though the 66

above dates mark the official establishment of the Air Force and the Air Force Dental Service, its history reaches back to 1917, with the Army Air Corps in World War I. During the Great War, as it was originally known, approximately 4,600 officers served in the Dental Corps. Often also deployed as surgical assistants and participating in battles, at war’s end they had treated 1,396,957 dental patients. Eight dentists died from disease, seven officers and seven enlisted dental assistants were killed in combat, and an additional 36 dental personnel were wounded in action. Undoubtedly for the future Air Force Dental Service, the most important dental officer to serve in that conflict was 1st Lt. George R. Kennebeck, who would go on to become the Air Force’s first assistant surgeon general for Dental Services and be

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U.S. Army photo by Sgt. Adrian C. Duff

“Aspiring to the highest ideals of quality care, Air Force dentistry integrates modern treatment modalities, teaching, and research along with administrative acumen in its goal of providing the finest possible oral health for Air Force personnel world-wide.” – Maj. Gen. Arthur J. Sachsel, Assistant Surgeon General for Dental Services 1982–1987

The Year in Veterans affairs & military medicine

air force medical service photos

acclaimed as the “Father of the Air Force Dental Corps” before his retirement in 1952 with the rank of major general.

Kennebeck, a 1916 graduate from the University of Iowa Dental School, was conscripted into the Army in 1917 and commissioned a first lieutenant. Though stationed in the States during the war, he was ordered to Vladivostok in 1918, where he participated in the ill-fated U.S. military intervention in Siberia to assist the White Russians fight the Bolsheviks who had seized power in 1917. Kennebeck was ordered to Manila in 1920, and after serving a year there, he returned to the United States and slowly rose through the ranks during the interwar years.

Following the outbreak of World War II, in January 1942 Lt. Col. Kennebeck was appointed to the new command of chief of the Dental Service in the Office of the Air Surgeon, Army Air Corps, and promoted to colonel.

As Dental Service chief, he led and oversaw research and treatment of a chronic problem that was beginning to affect pilots and aircrews: aerodontalgia (now barodontalgia) – toothaches that result from atmospheric decompression during high-altitude flying. In an alarming number of situations, the tooth pain was so bad pilots had to abort their missions. Kennebeck and his staff, which included Capt.

Kermit F. Knudtzon and later Capt. David F. Mitchell, became pioneers in this field. Working with civilian universities, research institutes, and other governmental agencies, they compiled data, identified the causes of the problem (the majority of cases were the result of pre-existing sinus conditions, untreated dental pathology, or faulty existing dental treatment), and developed treatment.

At the beginning of World War II, the Army Air Corps had 400 dentists. By war’s end that number had increased to 4,000. They found themselves working in every theater and under every imaginable condition, from steaming tropical jungles to frigid arctic tundra.

Capt. Warren Hester’s field experience, described in 50th Commemorative Anniversary of the United States Air Force Dental Service, 1949-1999 by Col. D. Keith Savage, was typical.

Deployed to Guadalcanal in the spring of 1942, he worked under extremely primitive conditions using World War I-era instruments, often within range of machine guns and mortars.

■■ Opposite: Members of the Medical Corps remove the wounded from Vaux, France, July 22, 1918. Dental Corps personnel often acted as surgical assistants during the war, and 22 were killed in action. ABOVE: Medical generals gathered in August 1949, when the newly minted Air Force Medical Service was but six weeks old. Pictured from left to right are Lt. Gen. Malcolm Grow (surgeon general), Maj. Gen. George R. Kennebeck (first Dental Corps chief 1949-1952), Gen. Harry Armstrong (surgeon general 1949-1954), Brig. Gen. Dan Ogle (surgeon general 1954-1958), Brig. Gen. Albert Schwichtenberg, and Brig. Gen. William Henry Powell (served as deputy surgeon general 1953-1957).

“We had to improvise everything,” he recalled. “Extractions and setting of fractured jaws had to be done by feel as we had no X-rays. The old-fashioned pump pedal may have been a blessing since we didn’t have electricity. I even did some metal crowns by rigging up a manual sling casting machine inside a large potato can.” After the war, he went into research and developed new dental field equipment. He was among the first dentists who transferred to the Air Force in 1949. He served in the military 33 years, retiring with the rank of colonel.

Forensic dentistry is sometimes the only way a severely mutilated body can be identified. During the war, Army Air Force dentists from the 8th Air Force expanded on existing Army medical forms by creating a more detailed Flying Personnel Dental Identification Form that all pilots and aircrews had to complete. As a result, many aircrew bodies that otherwise would have gone unnamed were positively identified.

The Korean War saw a major administrative shift in how dentists performed their duties. Prior to the conflict, dental teams were organically attached to units under the unit support program. During the Korean War, the concept of area dental support was implemented. Among other things, it removed dentists from operating in temporary facilities near the front lines to higher-quality fixed facilities farther back.

Though Air Force dentists were stationed in Southeast Asia in the early 1960s, their numbers were few, and it was not until ■■ Personnel of the Far East Air Forces were required to “see their dentist” regularly, whether they liked it or not. In this February 1951 photo, Capt. Paul E. Gallen, dental officer of the Far East Air Forces 452nd Light Bomb Wing, works on one of the members of the unit, while dental technician Staff Sgt. Robert K. Dunrkoop assists. The 452nd was the first all-Reserve unit to be called to active duty in the Korean War.

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1966 that the Dental Service received authorization to increase staffing levels that enabled it to fulfill its mission of providing dental support on a par with that provided in the United States.

Like other medical personnel in the Air Force and other branches, Air Force dentists and technicians in Southeast Asia volunteered for such humanitarian projects as People-to-People, Dental Med-Cap, and Civic Action. Dental teams would travel throughout the countryside instructing countless civilians in oral hygiene and performing dental work (usually extractions).

The Air Force Dental Service’s next major combat dentistry action occurred in Operation Desert Shield/Desert Storm.

About 97 officers and 259 technicians were deployed in support, and theirs proved to be the busiest of the health care components. The reason was the higher-than-average volume of reservist call-ups. It was discovered that about 10 percent of the reservists were dentally unqualified for overseas duty.

This problem was significantly reduced when Congress passed ■■ U.S. military personnel and volunteers offload the remains legislation creating a dental insurance program for reservists. of Jonestown, Guyana, victims from a 55th Aerospace Rescue Pioneering Air Force forensic dentists developing mass and Recovery Squadron HH-53 “Jolly Green Giant” helicopter. disaster identification protocols for use in aviation disas- The bodies were placed in coffins for transport to Dover Air ters had their work put to the test in four mass disasters (two Force Base, Delaware, where Air Force forensic dentists helped aviation) that occurred in the 1970s and 1980s: Tenerife, to identify them.

Spain; Jonestown, in Guyana; Beirut, Lebanon; and Gander, Newfoundland. Col. Kenton Hartman was an Air Force oral worked. Eventually, people became conditioned … and just litpathologist and a member of teams who worked on identi- erally gutted it out. ...” Hartman added, “What happened that’s fying bodies in them. of historical significance in the Jonestown disaster was that On March 27, 1977, at Tenerife airport in the Canary this was the first time that an automated, computer-assisted Islands, a KLM Boeing 747, attempting to take off, collided dental identification system was put into effect.” Developed by with a Pan Am 747 still on the runway, killing 583 people. forensic dentist Air Force Col. Bill Morlang and an Air Force Because the accident occurred on Spanish territory, Hartman computer specialist, the sorting and matching software proand the rest of the team encountered unexpected bureaucratic gram has been refined and updated over the years. delays that ultimately required State Department intervention Hartman, together with oral pathologist Col. Bob Brannon to allow the bodies of the Pan Am flight to be flown to Dover and their wives, was on vacation in Yugoslavia when, on Oct. Air Force Base mortuary in Delaware for identification.

23, 1983, a suicide truck bomber exploded his vehicle in the On Nov. 18, 1979, American evangelical cult leader Jim international military compound near the Beirut airport, Jones led his followers in a mass suicide ritual at Jonestown, killing 241 American servicemen. They had stopped at Aviano an American colony in northwestern Guyana, in which 918 Air Base, Italy, looking to spend the night before proceeding on. people died. In this case, Hartman recalled their main problem Instead, Hartman recalled, he and Brannon “were immediately was not a foreign bureaucracy; it was nature – tropical heat. kind of put under house arrest and told to get [our] fannies Within a week, Hartman said in an Armed Forces Institute of back to Frankfurt” where the bodies were being transported.

Pathology oral history, the victims’ Hartman was chairman of the flesh “had turned into a paste-like Department of Oral Pathology compound; it looked like mud. The when, on Dec. 12, 1985, an overodor was just horrendous.” loaded charter flight carrying ■■ Over the decades, the The bodies were transferred to soldiers from the 101st Airborne Air Force Dental Service the mortuary at Dover AFB for Division crashed shortly after an examination and identification takeoff at Gander, Newfoundland. has developed one of the process that eventually took 12 Hartman noted that because finest dental care programs weeks. Hartman remembered that, “almost all the victims were just in the world. Its influence because of the huge volume and totally burned,” Morlang’s dental advanced state of decay, “maggots identification software, used to a and impact extend well became a huge problem.” Various limited extent on the Jonestown beyond the service. efforts were tried to control the victims, was used “a lot with the population but, he said, “Nothing Gander incident.”

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air force medical service photos

■■ ABOVE: On Nov. 20, 1953, Maj. Gen. Harry G. Armstrong, Surgeon General, USAF (right), pins lieutenant bars on 1st Lt. Raya Rachlin, USAFR (center), following the ceremony commissioning her as the first female dentist to be sworn into the U.S. Air Force. Witnessing the ceremony is Col. Walter H. Bird, USAF. RIGHT: NASA astronaut Charles “Pete” Conrad, commander of the Skylab 2 mission, undergoes a dental exam by medical officer Joseph Kerwin in the Skylab Medical Facility.

Though full integration of the military would have to wait until President Harry Truman’s executive order in January 1948, African-American dentists were commissioned into the Dental Service’s ranks as early as World War I. In World War II, 132 African-American dentists were in uniform. Hampton Green, Jr., who entered the Air Force as a dentist in 1954, served 30 years and was one of the first African-American Air Force dentists to rise to the rank of colonel in 1971. In 2014, Maj. Gen. (Dr.) Roosevelt Allen became the first African-American assistant surgeon general for Dental Services.

In 1953, Raya Rachlin became the first woman to be commissioned an Air Force dentist, and would be the service’s only female dentist until well into the 1960s. By the 1980s, about 10 percent of the service’s dentists were women. In 1998, Col. Susan J. Smythe was the first woman appointed to a command dental surgeon position, at Space Command, Peterson Air Force Base (AFB), Colorado. At the start of the 21st century, the number of female Air Force dentists had risen to just under 15 percent.

It’s no surprise that the Air Force Dental Service was tasked to provide “optimum dental care to the space pilots, as well as finding a way to provide emergency dental care during prolonged space flight.” Guidelines for aerospace dentistry were first issued by the Surgeon General’s Office in 1957. When NASA began operations in Houston during the 1960s, dental care for the astronauts was primarily conducted by nearby Ellington AFB, Texas, with additional support from dentists at Lackland AFB in San Antonio, Texas. In 1962, shortly before his historic orbital space flight, dentists at Lackland were called upon to fix a tooth Lt. Col. John Glenn had chipped.

Because the single-man Mercury missions were so short, in-flight dental provisions were unnecessary. Astronauts for the longer two-man Gemini missions were supplied with a toothbrush. With the three-man Apollo program and its goal of landing men on the moon, aerospace dentistry

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became fully developed. Dental researchers at the Air Force’s School of Aviation Medicine faced challenges presented by long-term weightless flight in a cramped space that were, in a word, unique. They ranged from basic care such as the brushing and flossing of teeth, to mission-threatening issues such as barodontalgia.

The detergents in regular toothpastes foam excessively in zero gravity conditions. And astronauts had no place to dispose of saliva and dentifrice in the cramped Apollo cabin. To overcome this, Maj. Ira Shannon created “Nasadent,” a foamless ingestible dentifrice.

Researchers created a compact emergency dental kit that contained everything an astronaut needed to provide dental care, from fixing a chipped tooth to performing a simple extraction. Air Force dental officers then taught the astronauts the necessary dental procedures. Though created for the Apollo program, the kits were not included in space missions until Skylab became operational in the early 1970s.

It’s a historical footnote that, thanks to the extensive preventative protocols and care conducted by all the branches of America’s dental military services, the emergency dental kits never had to be used. Unfortunately, Soviet Cosmonauts were not as fortunate. During his Salyut 6 space flight in 1978, Yuri Romanenko experienced an excruciating toothache. But the Soviet space program had made no provisions for in-flight dental care. As a result, during the entire two-week mission, Romanenko was in constant agony.

Over the decades, the Air Force Dental Service has developed one of the finest dental care programs in the world.

Its influence and impact extend well beyond the service. Air Force dentists are on the faculties of many American dental schools, often holding chair positions. They have conducted research and written articles that have become classics in the field, and are in leadership positions in many professional organizations. The result is a rich history of contribution to the field of dentistry that continues to this day. n 71

The Year in Veterans affairs & military medicine

Pay, Benefits, Budgets, and Reform n For the Department of Veterans Affairs (VA) and the 9 million former warfighters enrolled in the VA Health Care System (out of more than 22 million living veterans), 2014 will go down as one of the most controversial and – for veterans – confusing years in VA history, certainly since it achieved Cabinet-level status in 1989.

Flooded with the rapid growth of the veterans’ community as a result of the wars in Southwest Asia – and especially the increasing number dealing with post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) – the VA was accused of leaving tens of thousands of veterans waiting months to be seen, rather than the 14 days – down from the previous standard of 30 – former Secretary Eric K. Shinseki had implemented.

When he was confirmed by the Senate as the new VA secretary in July 2014, about two months after Shinseki’s 72

resignation, West Point graduate and Procter & Gamble CEO Robert McDonald pledged to do whatever was necessary to get the VA back on track as quickly as possible. After meetings with his new staff, McDonald set out on a whirlwind tour of VA facilities – both those with high ratings, such as Reno, Nevada, and those with serious problems, such as Phoenix, Arizona – and speeches to major Veterans Service Organizations (VSOs).

Since May – and including changes ordered by Congress in the Veterans Access, Choice and Accountability Act of 2014 (VACAA) – the VA has announced a wide range of efforts to resolve the department’s problems and improve the delivery of benefits and services to veterans, including: • contacting nearly a quarter million veterans to get them off wait lists and into clinics sooner;

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U.S. Marine Corps photo by Pfc. Joshua W. Grant

By J.R. Wilson

The Year in Veterans affairs & military medicine

VA Photo / Reynaldo Leal

• referring more than 838,000 veterans to private-sector doctors and facilities for care (up more than 166,000 from the same time last year); • improving monitoring of non-VA care “to ensure veterans receive the best that they deserve;” • ordering “the antiquated appointment scheduling system” updated in the short term; • beginning acquisition of a comprehensive, state-of-the-art commercial-off-the-shelf scheduling system; • continuing to expand digital technology to free more people to care for veterans; • ordering VA facilities to add more clinic hours; and • deploying mobile medical units and using temporary staffing resources to provide care to more veterans as quickly as possible in all health care facilities.

“We’re going to improve forecasting for resources, then we can develop an effective strategy for meeting increased demands,” McDonald told the AMVETS National Conference on Aug. 13. “We’re determining which processes need to be streamlined and where we need to reorganize – that is, to more efficiently and effectively use resources to serve veterans. To help with that process, I’m establishing a board of physicians to advise me on best practices for delivering timely and quality health care.

“We’re building a more robust, continuous system for measuring patient experiences, to provide real-time, site-specific information on patient satisfaction. And we’re going to learn what other leading health care systems are doing to track patient access experiences. Finally, we’re improving communications between the field and the central office, between employees and leadership and between VA and AMVETS and other VSOs and stakeholders. … We are going to create a more open, less hierarchical culture so that employees can more easily and confidently contribute their ideas and help us improve.”

292,675 new veterans began receiving compensation benefits in FY 13, along with 14,763 survivors who began receiving service-connected death benefits. Total compensation recipients as of FY 13 were 3,743,259 and 376,979, respectively. In terms of estimated annual benefits paid, veterans received an average of $13,131 each – for an overall total of $49.15 billion – while service-connected death benefits to survivors averaged $15,303 each, an overall total of $5.77 billion.

Nearly 75 percent of recipients are from the Vietnam (196175) and Gulf wars (1990-present) eras, as both World War II and Korea-era recipients have declined to only 4 percent each, and the 25 total years of “peace” represent 18 percent.

Compensation to males is 10 times the totals for females, although the growing number of women veterans – especially those with VA-covered disabilities or illnesses – have slowly raised their overall share of total benefits paid. For FY 13, for example, new compensation benefits to men outnumbered those to women by only 8-to-1.

Just how much the wars in Southwest Asia (listed by the VA as a continuum from Desert Storm in 1991 through enforcement of a “no-fly” zone over Iraq for a decade, then Operation Iraqi Freedom and Operation Enduring Freedom since 9/11) have affected the VA is evident from the total number of beneficiaries from the “Gulf wars era” – 1,508,682 – at 40 percent the highest from any conflict

■■ OPPOSITE: Patrick E. Libby, a retired master sergeant, receives a flu shot during the quarterly retiree town hall meeting held at the Naval Hospital aboard Marine Corps Base Camp Lejeune. RIGHT: U.S. Navy Veteran Rick Henderson stops VA Secretary Robert McDonald to talk about the care he’s received at the Las Vegas VAMC.

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73

The Year in Veterans affairs & military medicine

currently receiving payments. The total amount of those providing veterans with housing assistance, education, vocabenefits – $17,735,811,810 – is only slightly less than those tional training, etc. About 3.5 million veterans received VBA from Vietnam, which represent 43 percent compared to 36 disability compensation benefits in 2013.

Those figures represent a significant change since the start percent (Gulf wars) of the VA’s annual compensation payof Operation Enduring Freedom in 2001. The number of vetments of $49,151,877,576. erans receiving disability payments rose According to a Congressional Budget by almost 55 percent, from 2.3 million to Office (CBO) analysis, VA disability 3.5 million, during that period, despite a compensation to veterans amounted to 17 percent decline in the total population $54 billion in 2013, or about 70 percent ■■ “I don’t of living veterans, from nearly 27 million of the annual mandatory spending for deny that the to 22 million. While only 9 percent of all the Veterans Benefits Administration veterans received disability benefits in (VBA), which handles payments to vetchallenges ahead 2000, some 16 percent were by 2013. In erans for medical conditions or injuries are significant. addition, the inflation-adjusted average incurred or aggravated during active There’s a lot to do. annual disability payment per veteran duty that are separate from the health rose nearly 60 percent, from $8,100 in benefits provided through the Veterans And there’s a lot Health Administration (VHA). The 2000 to $12,900 in 2013, reflecting both at stake.” balance of the VBA’s mandatory the average number and severity of comspending that year went to programs pensable disabilities per veteran.

74

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Photo by Sgt. Anthony Housey

■■ A pre-retirement seminar held at Camp Ripley, Indiana, Oct. 20, 2012, brought National Guard and Army Reserve soldiers in to learn about retiree benefits and the physical and mental stressors that come with the change in lifestyle while retired.

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■ Not made with natural rubber latex Important Safety Information AFLURIA®, influenza vaccine, is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. Administration of AFLURIA with a needle and syringe is approved for use in persons 5 years of age and older. Administration of AFLURIA with the PharmaJet® Stratis® Needle‐Free Injection System is approved for use in persons 18 through 64 years of age only.

AFLURIA is contraindicated in individuals with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies.

Febrile events were also observed in children 5 to less than 9 years of age.

If Guillain‐Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.

Antibody responses in persons 65 years of age and older were lower after administration of AFLURIA as compared to younger adult subjects.

In children 5 through 17 years of age, most common injection‐site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were pain, redness, and swelling. The most common systemic adverse events were headache, myalgia, irritability, malaise, and fever.

In adults 18 through 64 years of age, the most common injection‐site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were tenderness, pain, swelling, and redness, itching. The most common systemic adverse reactions observed were muscle aches, headache and malaise.

In adults 18 through 64 years of age, the most common injection‐site adverse reactions observed in clinical studies with AFLURIA when administered by the PharmaJet Stratis Needle‐Free Injection System up to 7 days post‐vaccination were tenderness, swelling, pain, redness, itching and bruising. The most common systemic adverse events within this period were myalgia, malaise, and headache.

If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

In adults 65 years of age and older, the most common injection‐site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were tenderness and pain.

AFLURIA should be given to a pregnant woman only if clearly needed.

Vaccination with AFLURIA may not protect all individuals.

AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman.

Please see brief summary of full prescribing information on next page.

*Contains thimerosal.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

For a list of authorized distributors, call 1-888-4FLU-OFF (1-888-435-8633).

To learn more about Afluria, visit www.afluria.com.

AFLURIA is a registered trademark of CSL Limited used under license. bioCSL Pty Ltd. and bioCSL Inc. are subsidiaries of CSL Limited. © 2014 bioCSL Inc. All rights reserved. bioCSL is a trademark of CSL Limited.

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AFLURIA, Influenza Vaccine Suspension for Intramuscular Injection 2014-2015 Formula Initial U.S. Approval: 2007

• •

BRIEF SUMMARY OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AFLURIA safely and effectively. See full prescribing information for AFLURIA. -------------------------------RECENT MAJOR CHANGES------------------------------------Dosage and Administration (2) 08/2014 -------------------------------INDICATIONS AND USAGE------------------------------------• AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. (1) • AFLURIA is approved for use in persons 5 years of age and older. (1) ------------------------------DOSAGE AND ADMINISTRATION----------------------------For intramuscular (IM) injection only, by needle and syringe (5 years of age and older) or by PharmaJet® Stratis® Needle-Free Injection System (18 through 64 years of age). A single dose is 0.5 mL. (2) Age

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5 years through 8 years

One dose or two doses at least 1 month aparta

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a

----------------------------DOSAGE FORMS AND STRENGTHS----------------------------AFLURIA is a suspension for injection supplied in two presentations: • 0.5 mL pre-filled syringe (single dose) (3, 11) • 5 mL multi-dose vial (ten 0.5 mL doses) (3, 11) • -------------------------------------CONTRAINDICATIONS-----------------------------------• Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine. (4, 11) ------------------------------WARNINGS AND PRECAUTIONS-----------------------------• Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years.

Febrile events were also observed in children 5 through 8 years of age.

(5.1)

•

If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks. (5.2) Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. (5.3) Immunocompromised persons may have a diminished immune response to AFLURIA. (5.4)

----------------------------------ADVERSE REACTIONS---------------------------------------• In children 5 through 17 years of age, the most common injection-site adverse reactions when administered by needle and syringe were pain (≥60%), redness (≥20%) and swelling (≥10%). The most common systemic adverse events were headache, myalgia (≥20%), irritability, malaise and fever (≥10%). (6.1) • In adults 18 through 64 years of age, the most common injection-site adverse reactions when administered by needle and syringe were tenderness (≥60%), pain (≥40%), swelling (≥20%), and redness, itching (≥10%). The most common systemic adverse events were muscle aches (≥30%) and headache, malaise (≥20%). (6.1) • In adults 18 through 64 years of age, the most common injectionsite adverse reactions when administered by the PharmaJet Stratis NeedleFree Injection System up to 7 days post-vaccination were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events within this period were myalgia, malaise (≥30%), and headache (≥20%). (6.1) • In adults 65 years of age and older, when administered by needle and syringe the most common injection-site adverse reactions were tenderness (≥30%) and pain (≥10%). No systemic adverse events occurred in ≥10% of subjects in this age group (6.1) To report SUSPECTED ADVERSE REACTIONS, contact bioCSL Inc. at 1-844-2752461 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

---------------------------------USE IN SPECIFIC POPULATIONS----------------------------• Safety and effectiveness of AFLURIA have not been established in pregnant women or nursing mothers. (8.1, 8.3) • Antibody responses were lower in geriatric subjects than in younger subjects. (8.5) • AFLURIA is not approved for use in children less than 5 years of age because of increased rates of fever and febrile seizures. One comparatorcontrolled trial demonstrated higher rates of fever in recipients of AFLURIA as compared to a trivalent inactivated influenza vaccine control.

(8.4) Based on August 2014 Version

The Year in Veterans affairs & military medicine

Photo by MC1 James Stenberg

■■ Hospitalman Henry Molina, a corpsman with Naval Hospital Pensacola, Florida, checks the blood pressure of Karen Kearney during her appointment with Family Medicine. Making appointments is just one of the options TRICARE Online provides to TRICARE beneficiaries to make receiving medical services even easier.

Overall, according to the VA, inflation-adjusted disability benefits have almost tripled since FY 2000, from $20 billion to $54 billion in 2013. The department projects that total to reach $60 billion by the end of 2014 and jump to $64 billion in 2015 – a 19 percent increase in only two years. Given anticipated continued growth as the military downsizes through the rest of this decade, putting more veterans into the system, and an increasingly strained federal budget, Congress and the VA continue to look for ways to contain overall spending through 2014 while still meeting the government’s obligations to veterans, concluded the CBO report “Veterans’ Disability Compensation: Trends and Policy Options,” released in August 2014.

Among possible options reviewed by the CBO report were modifying VA processes for identifying service-connected disabilities, changing payment rates, coordinating with other federal benefits or changing the tax treatment of benefits.

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“The option with the largest estimated budgetary effect would eliminate the program known as concurrent receipt.

For decades before 2003, a veteran’s retirement pay from the Department of Defense (DOD) was reduced by the amount of any VA disability benefits that person received. Since then, under concurrent receipt, the retirement pay some veterans receive either is not reduced or is reduced by a smaller amount,” the report stated.

“CBO estimates that eliminating concurrent receipt [and thereby returning to the previously longstanding policy] would save the federal government $119 billion from 2015 through 2024. By contrast, extending concurrent receipt to all veterans who would be eligible both for disability benefits and for military retirement pay would cost $30 billion over the same period. The estimated budgetary effects of the other options range from savings of $64 billion through 2024 to additional outlays of $9 billion for the same period.”

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The Year in Veterans affairs & military medicine

Meanwhile, an interim report from the Military going up only slightly in FY 2015, by about $4 per individual Compensation and Retirement Modernization Commission and $8 per family. in July, while detailing significant growth in spending on Retired military personnel are covered under TRICARE, retirement and health benefits since 9/11, offered no concrete while, under CHAMPVA, the beneficiary cannot be retired solutions. Total compensation programs for active service military nor can their dependents, who also must apply for members, retirees, Reserve components, veterans, and fami- benefits under TRICARE. To be eligible for CHAMPVA, the lies, delivered through several federal departments, totaled beneficiary must fall into one of four categories: $340 billion in FY 2014. The components of that within 1. The spouse or child of a veteran who has been rated perthe DOD budget represent about one-third of the Defense manently and totally disabled for a service-connected disDepartment’s overall spending. ability by a VA regional office; The report – a final version of which is to go to President 2. The surviving spouse or child of a veteran who died from a Barack Obama in February 2015 – also noted that Tricare VA-rated service-connected disability; Prime premiums rose by only 17 percent from 1999 to 2013, 3. The surviving spouse or child of a veteran who was at the while insurance premiums in the pritime of death rated permanently and vate sector jumped some 196 percent. totally disabled; or “Although the commission found 4. The surviving spouse or child of a that compensation funding has military member who died in the line ■■ “The truth increased substantially over the last of duty, not due to misconduct (in most of the matter is two decades, as has been repeatedly of these cases, these family members are reported in the national press, these eligible for TRICARE, not CHAMPVA). that we’ve failed simple trends need to be examined in In addition to the changes contained in a number of greater detail before any conclusion in VACAA, McDonald is striving to ways. We need to can be drawn regarding fiscal sustaindeal with the VA’s loss of trust among ability,” the blue ribbon panel wrote. veterans, members of Congress, and do better. Much Funding those benefits has not the American people. better. Right been the only problem, however. The “I don’t want VA to be known for now, it’s up to VA also found itself severely short just ‘standard’ care – I want it known of doctors, nurses, and other peras ‘THE Standard’ in health care,” he the department sonnel required to handle the massive told the Blinded Veterans Association to reaffirm its increase in patients. That was a major National Convention Aug. 19, 2014. “To worth and regain help do that, I’m establishing a board of part of VACAA, passed by Congress in July and signed into law by the presiphysicians – comprised of the foremost veterans’ trust.” dent in August, allocating an addimedical minds in the nation – to advise tional $15 billion to the VA. me on industry best practices. I know That includes $5 billion to hire phyI’ve just laid down an ambitious agenda. sicians and other medical staff and However, all this, and more, can be done. to improve VA infrastructure, and $10 billion to fund addi“The words of the West Point Cadet Prayer still guide me: tional purchased care until internal capability can be built ‘Choose the harder right instead of the easier wrong.’ I’m here to meet demand. VACAA also authorizes the VA to lease 27 to promise you VA will get beyond its present difficulties and additional major medical facilities to provide more patient be the stronger for it. The truth of the matter is that we’ve failed treatment space. in a number of ways. We need to do better. Much better. Right Oddly, two words the new VA leadership have rarely now, it’s up to the department to reaffirm its worth and regain mentioned in a series of public speeches and meetings veterans’ trust. Over the past months, we’ve been forced to take are CHAMPVA (Civilian Health and Medical Program a hard look at ourselves through their eyes and through their of the Department of Veterans Affairs) and TRICARE, experiences – good, bad, and indifferent.” a major part of the Military Health System, managed by Even with the changes ordered by Congress, including the the Defense Health Agency under the assistant secretary additional $15 billion in funding, the former Airborne Ranger of defense for health affairs, to provide health care to uni- acknowledged the entire department faces more tough times. formed service members (active, Guard/Reserve, retired) “I don’t deny that the challenges ahead are significant.

There’s a lot to do. And there’s a lot at stake,” McDonald said. and their families worldwide.

Changes to TRICARE coverage and fees – suggested, “But in tough times, I’ve always turned to a favorite saying of planned, or put into effect – have drawn sharp criticism from mine: ‘A pessimist sees the difficulty in every opportunity; VSOs and others. Some of those already have been canceled an optimist sees opportunity in every difficulty.’ Well, I’m an or curtailed; TRICARE annual fees, for example, will be optimist. And a realist. And a pragmatist.” n

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79

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Use in patients who are opioid dependent may precipitate acute abstinence syndrome.

Patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects should be monitored in an appropriate healthcare setting.

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.

The following adverse reactions have been identified during use of naloxone hydrochloride in the postoperative setting: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in postoperative patients have resulted in significant reversal of analgesia and have caused agitation.

Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated signs and symptoms of opioid withdrawal including: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see brief summary of full Prescribing Information on next page.

Reference: 1. Data on file. kaleo, Inc.

©2014 kaleo, Inc. All rights reserved. PP-EVZ-US-0214

September 2014

BRIEF SUMMARY OF PRESCRIBING INFORMATION (see full Prescribing Information for complete product information) EVZIO (naloxone hydrochloride injection) Auto-Injector for intramuscular or subcutaneous use Initial U.S. Approval: 1971 TM

INDICATIONS AND USAGE EVZIO is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. EVZIO is intended for immediate administration as emergency therapy in settings where opioids may be present. EVZIO is not a substitute for emergency medical care.

Important Administration Instructions • EVZIO is for intramuscular and subcutaneous use only.

• Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of EVZIO and the Instructions for Use. • Seek emergency medical care immediately after use. Since the duration of action of most opioids exceeds that of naloxone hydrochloride, and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance, and administer repeated doses of EVZIO as necessary. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of EVZIO. • Additional doses of EVZIO may be required until emergency medical assistance becomes available.

• Do not attempt to reuse EVZIO. Each EVZIO contains a single dose of naloxone.

• Visually inspect EVZIO through the viewing window for particulate matter and discoloration prior to administration.

Do not administer unless the solution is clear and the glass container is undamaged.

The Instructions for Use should be read by the patient or caregiver at the time they receive a prescription for EVZIO. Provide the following instructions to the patient or caregiver: • EVZIO must be administered according to the printed instructions on the device label or the electronic voice instructions (EVZIO contains a speaker that provides voice instructions to guide the user through each step of the injection). If the EVZIO electronic voice instruction system does not operate properly, EVZIO will still deliver the intended dose of naloxone hydrochloride when used according to the printed instructions on its label.

• Once the red safety guard is removed, EVZIO must be used immediately or disposed of properly. Do not attempt to replace the red safety guard once it is removed.

Upon actuation, EVZIO automatically inserts the needle intramuscularly or subcutaneously, delivers 0.4 mg naloxone hydrochloride injection, and retracts the needle fully into its housing. Post-injection, the black base locks in place, a red indicator appears in the viewing window, and electronic visual and audible instructions signal that EVZIO has delivered the intended dose of naloxone hydrochloride and instructs the user to seek emergency medical attention.

Dosing Information Administer the initial dose of EVZIO to adult or pediatric patients intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary, and seek emergency medical assistance. Administer EVZIO as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death. The requirement for repeat doses of EVZIO depends upon the amount, type, and route of administration of the opioid being antagonized.

If the desired response is not obtained after 2 or 3 minutes, another dose of EVZIO may be administered. If there is still no response and additional doses are available, additional doses of EVZIO may be administered every 2 to 3 minutes until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone.

Dosing in Adults and Pediatric Patients over Age One Instruct patients or their caregivers to administer EVZIO according to the Instructions for Use, intramuscularly or subcutaneously.

Dosing in Pediatric Patients under Age One In pediatric patients under the age of one, the caregiver should pinch the thigh muscle while administering EVZIO. CONTRAINDICATIONS EVZIO is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.

WARNINGS AND PRECAUTIONS Duration of Effect The duration of action of most opioids is likely to exceed that of EVZIO resulting in a return of respiratory and/or central nervous system depression after an initial improvement in symptoms. Therefore, it is necessary to seek immediate emergency medical assistance after delivering the first dose of EVZIO, keep the patient under continued surveillance, and repeat doses of EVZIO as necessary. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete. Large doses of naloxone hydrochloride are required to antagonize buprenorphine because the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression.

Precipitation of Severe Opioid Withdrawal The use of EVZIO in patients who are opioid dependent may precipitate an acute abstinence syndrome characterized by the following signs and symptoms: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes.

Abrupt postoperative reversal of opioid depression after using naloxone hydrochloride may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events.

These events have occurred in patients most of whom had pre-existing cardiovascular disorders or received other drugs which may have similar adverse cardiovascular effects. Although a direct cause and effect relationship has not been established, after use of naloxone hydrochloride, patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects should be monitored for hypotension, ventricular tachycardia or fibrillation, and pulmonary edema in an appropriate healthcare setting. It has been suggested that the pathogenesis of pulmonary edema associated with the use of naloxone hydrochloride is similar to neurogenic pulmonary edema, ie, a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.

ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Duration of Effect • Precipitation of Severe Opioid Withdrawal The following adverse reactions have been identified during postapproval use of naloxone hydrochloride in the postoperative setting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in postoperative patients have resulted in significant reversal of analgesia and have caused agitation.

Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated an acute withdrawal syndrome. Signs and symptoms have included: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B Risk Summary There are no adequate and well-controlled studies with EVZIO in pregnant women. Animal studies were conducted with naloxone hydrochloride given during organogenesis in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg/day. These studies demonstrated no embryotoxic or teratogenic effects due to naloxone hydrochloride. Because animal reproduction studies are not always predictive of human response, EVZIO should be used during pregnancy only if clearly needed.

Clinical Considerations Naloxone hydrochloride crosses the placenta, and may precipitate withdrawal in the fetus as well as in the opioiddependent mother. The fetus should be evaluated for signs of distress after EVZIO is used. Careful monitoring is needed until the fetus and mother are stabilized.

Data Animal Data Naloxone hydrochloride was administered during organogenesis to mice and rats at doses 4-times and 8-times, respectively, the dose of 10 mg/day given to a 50 kg human (when based on body surface area or mg/m2). These studies demonstrated no embryotoxic or teratogenic effects due to naloxone hydrochloride.

Nursing Mothers It is not known whether naloxone hydrochloride is present in human milk. Because many drugs are present in human milk, exercise caution when EVZIO is administered to a nursing woman.

Pediatric Use The safety and effectiveness of EVZIO (for intramuscular and subcutaneous use) have been established in pediatric patients for known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Use of naloxone hydrochloride in pediatric patients is supported by evidence from adequate and well-controlled studies of naloxone hydrochloride in adults with additional data from 15 clinical studies (controlled and uncontrolled) in which neonates and pediatric patients received parenteral naloxone in doses ranging from 0.005 mg/kg to 0.01 mg/kg. Safety and effectiveness are also supported by use of other naloxone hydrochloride products in the postmarketing setting as well as data available in the medical literature and clinical practice guidelines.

Absorption of naloxone hydrochloride following subcutaneous or intramuscular administration in pediatric patients may be erratic or delayed. Even when the opiate-intoxicated pediatric patient responds dramatically to naloxone hydrochloride injection, he/she must be carefully monitored for at least 24 hours as a relapse may occur as naloxone is metabolized.

In opioid-dependent pediatric patients, (including neonates), administration of naloxone may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening and should be treated according to protocols developed by neonatology experts.

In neonates and pediatric patients less than 1 year of age, careful observation of the administration site for evidence of residual needle parts and/or signs of infection is warranted.

Geriatric Use Geriatric patients have a greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Therefore, the systemic exposure of naloxone can be higher in these patients. Clinical studies of naloxone hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies to evaluate the carcinogenic potential of naloxone have not been completed.

Mutagenesis Naloxone was weakly positive in the Ames mutagenicity and in the in vitro human lymphocyte chromosome aberration test, but was negative in the in vitro Chinese hamster V79 cell HGPRT mutagenicity assay and in the in vivo rat bone marrow chromosome aberration study.

Impairment of Fertility Reproduction studies conducted in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg/day (when based on surface area or mg/m2), demonstrated no adverse effect of naloxone hydrochloride on fertility.

PATIENT COUNSELING INFORMATION Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Instructions for Use).

Instruct patients and their family members or caregivers to: • Become familiar with the following information contained in the carton as soon as they receive EVZIO: — EVZIO Instructions for Use — Trainer for EVZIO Instructions for Use — Trainer for EVZIO • Practice using the Trainer before EVZIO is needed.

— Each EVZIO (which is purple and yellow) can only be used one time; however, the Trainer (which is black and white) can be re-used for training purposes and its red safety guard can be removed and replaced.

— Both EVZIO and the Trainer for EVZIO incorporate the electronic voice instruction system.

• Make sure EVZIO is present whenever persons may be intentionally or accidentally exposed to an opioid to treat serious opioid overdose (ie, opioid emergencies).

Instruct patients and their family members or caregivers how to recognize the signs and symptoms of an opioid overdose requiring the use of EVZIO such as the following: • Extreme sleepiness – inability to awaken a patient verbally or upon a firm sternal rub.

• Breathing problems – this can range from slow or shallow breathing to no breathing in a patient who cannot be awakened.

• Other signs and symptoms that may accompany sleepiness and breathing problems include the following: — Extremely small pupils (the black circle in the center of the colored part of the eye) sometimes called “pinpoint pupils.”

— Slow heartbeat and/or low blood pressure.

Instruct them that when in doubt, if a patient is unresponsive, and an opioid overdose is suspected, administer EVZIO as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death. Instruct them to seek emergency medical assistance after administering the first dose of EVZIO. Duration of Effect Instruct patients and their family members or caregivers that since the duration of action of most opioids may exceed that of naloxone, seek immediate emergency medical assistance, keep the patient under continued surveillance, and administer repeated doses of EVZIO as necessary.

Limited Efficacy for/with Partial Agonists or Mixed Agonist/Antagonists Instruct patients and their family members or caregivers that the reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete.

Precipitation of Severe Opioid Withdrawal Instruct patients and their family members or caregivers that the use of EVZIO in patients who are opioid dependent may precipitate an acute abstinence syndrome characterized by the following signs and symptoms: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated, and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes.

Administration Instructions Instruct patients and their family members or caregivers about the following important information: • EVZIO is user actuated and may be administered through clothing (eg, pants, jeans) if necessary.

• Inject EVZIO while pressing into the anterolateral aspect of the thigh. In pediatric patients less than 1 year of age, pinch the thigh muscle while administering EVZIO. • Upon actuation, EVZIO automatically inserts the needle intramuscularly or subcutaneously, delivers the naloxone, and retracts the needle fully into its housing. The needle is not visible before, during, or after injection.

• Each EVZIO can only be used one time.

• If the electronic voice instruction system of EVZIO does not work properly, EVZIO will still deliver the intended dose of naloxone hydrochloride when used according to the printed instructions on its label.

• The electronic voice instructions are independent of activating EVZIO and are not required to wait for the voice instructions to be completed prior to moving to the next step in the injection process.

• Post-injection, the black base locks in place, a red indicator appears in the viewing window and electronic visual and audible instructions signal that EVZIO has delivered the intended dose of naloxone hydrochloride.

• EVZIO’s red safety guard should not be replaced under any circumstances. However, the Trainer is designed for re-use and its red safety guard can be removed and replaced.

• It is recommended that patients and caregivers become familiar with the training device provided and read the Instructions for Use ; however, untrained caregivers or family members should still attempt to use EVZIO during a suspected opioid overdose while awaiting definitive emergency medical care.

• Periodically visually inspect the naloxone solution through the viewing window. If the solution is discolored, cloudy, or contains solid particles, replace it with a new EVZIO. • Replace EVZIO before its expiration date.

Manufactured for: kaleo, Inc. Richmond, VA 23219 *For California Only: This product uses batteries containing Perchlorate Material – special handling may apply.

See www.dtsc.ca.gov/hazardouswaste/perchlorate

©2014 kaleo, Inc. All rights reserved. PP-EVZ-US-0214 September 2014

The Year in Veterans affairs & military medicine

Face and Hand Transplant Advances

By Gail Gourley n When the first face transplantation surgery “To date, we have had no active-duty military members was performed in Paris, France, in 2005 on a female victim of who have received a [face] transplant, although several have a dog mauling, it marked a medical milestone. The scope of been evaluated by the civilian centers that are currently doing transplantation surgery expanded, and nearly a decade later, face transplantation,” said Martin.

28 face transplantation procedures have been done worldThe number of candidates for face transplantation in the wide, seven of which have occurred in the United States. military from wartime trauma can’t be accurately deterIn recent years, the Department of Defense (DOD) has mined, Martin said, “because it hasn’t been established yet provided funds to civilian centers for face and hand trans- who really is that ideal candidate.” He explained that conplantation surgeries and research in an effort to benefit war- ventional techniques of reconstructing a face, like grafts or injured soldiers who have suffered catastrophic injuries to flap surgery, bringing in tissue from other places in the body the face or limbs for which tradito rebuild or re-create the missing tional reconstructive procedures or part, is “fairly effective in most cases. prosthetics are insufficient.

Sometimes when there’s composite But these initiatives also translate tissue loss, meaning bone, muscle, ■■ “That’s kind of to improving lives across society in skin, and fat of the face, in the centhe holy grail. That the civilian population. tral portion of the face, it’s a very dif“Currently in the United States, ficult area to rebuild through current science is what could it’s considered still experimental conventional reconstructive procetake this from an surgery, so funding is certainly dures, so those are the patients we experimental, rarely an issue,” said Army Col. Barry tend to believe may be a good candiMartin, chief of plastic surgery date for a face transplant.” performed operation at Walter Reed National Military In an effort to assist health care to something that is Medical Center (WRNMMC), who providers and potential transplant much more routine recently discussed the state of these patients in obtaining correct inforintensely complicated transplanmation and referrals, Martin said and matter of fact.” tation procedures and some of the they’re establishing a tri-service current and future challenges. transplant advisory board at the “The military and the Defense Uniformed Services University of Department [have] put in quite a bit of money and effort the Health Sciences in Bethesda, Maryland. It’s designed to into advancing that science because of the potential possi- be a one-call center staffed by surgeons and coordinators. bility for some of our wounded warriors, and then conse“If a practitioner, provider, patient – anybody, anywhere quently through translational initiatives, [to be] available that has access to care in the military system – if they have a for civilians,” he said. question, potential referral, or if a patient just wants to know Supported by funding from DOD agencies including the if they may be a candidate or wants more information, they Armed Forces Institute of Regenerative Medicine and the just have to call one place, and we’ll get that person or that Office of Naval Research, face or hand transplantation sur- provider to the resources and potential practitioners that may geries have been performed at the Cleveland Clinic, Brigham be able to help them,” he said. and Women’s Hospital, the University of Maryland Medical Aside from face and hand transplantation, Martin said, Center, and John Hopkins Hospital. “regenerative medicine initiatives have contributed probably The face transplantation surgeries have all been performed most greatly over the last decade of wartime surgical care as on civilian trauma victims. far as the reconstructive aspect goes. Most of what we do as 82

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The Year in Veterans affairs & military medicine

photo by David Kamm

■■ Face transplant recipient Jim Maki and Cheryl DeLuca, chief of the Natick Contracting Division, speak after a presentation at Natick Soldier Systems Center in Natick, Massachusetts.

reconstructive plastic surgeons really is building on fundamentals that have been around in civilian and trauma surgery in the last couple decades. Nothing we’re doing around wartime is necessarily revolutionary, but it’s using those same principles to repair the damages brought on by war …

But some of the advances in the molecular basis of healing and inflammation and wound care that is occurring through research and molecular initiatives, that’s what’s getting into the real science of controlling a wound.”

Martin explained that one of the major challenges, particularly in devastating war injuries, is that the surrounding tissue environment that they’re operating in is so inflamed and damaged that normal healing is very difficult.

“Controlling those wounds through advanced wound care products and techniques is what allowed for some of our conventional type of reconstruction to have a better outcome,” he said.

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If conventional reconstructive techniques are insufficient and transplantation is considered, Martin explained that transplant recipients must take lifelong medications that suppress their immune systems in order to prevent tissue rejection, and the ramifications of these lifetime immunosuppressants include significant health risks for patients that must be taken seriously.

“That’s kind of the holy grail,” said Martin of the immunosuppression issue. “That science is what could take this from an experimental, rarely performed operation to something that is much more routine and matter of fact.”

Unless the donor is an identical twin, the immune system must be suppressed to allow the body to accept the transplanted organ or tissue. And it’s even more difficult to do that in a face or hand transplant than with a solid organ transplant due to the complexity of the different types of tissue.

“When you’re talking about doing a composite tissue, like a face or a hand, it’s bone, fat, skin, muscle; those things 83

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Teleflex and Pilling are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. Š 2014 Teleflex Incorporated. All rights reserved. MC-000377

The Year in Veterans affairs & military medicine

U.S. Marine Corps photo by Sgt. Mallory S. VanderSchans HQMC Combat Camera

■■ The 35th commandant of the Marine Corps, Gen. James F. Amos, right, and 17th sergeant major of the Marine Corps, Sgt. Maj. Micheal P. Barrett, left, visit with Army Sgt. Brendan Marrocco at Johns Hopkins Medical Center in Baltimore, Maryland, May 8, 2013. Marrocco received a double-arm transplant with a new anti-rejection technique after losing all his limbs to a roadside bomb while serving in Iraq in 2009.

involved are a pretty intricate mix of immunosuppression.

It’s very difficult to allow the body to tolerate those kind of complex tissues, so it’s even more important for these composite tissues, face and hand, even more so than solid organ, to get that immunosuppression mix correct,” he said.

The upside of immunosuppression medications, Martin explained, is that the body tolerates the new tissue or organ, but the downside is that you’re blunting the body’s ability to reject infection or tumor. Additionally, the medications themselves can cause other complications, such as kidney and liver issues.

“For most of these transplants that are happening, both for face and hand, they’re on standard triple immunosuppression therapy,” he said. “There are a couple centers that are going into single-agent immunosuppression, which conceptually is a much better idea if you’re talking about longterm effects on the body. There isn’t, at this point, established ‘the’ one way to do it, so all centers are involved in transplantation research … Some are doing bone marrow

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transplants at the time of the organ transplantation to help the recipient’s body tolerate some of the new transplant tissue. We don’t have the answer yet, but probably most of the money and effort and research for both of these initiatives involve trying to find that way to make the body immunotolerant. That has not been achieved yet.”

Martin said the clinical results for patients who have received face transplantation are very good, citing return of their ability to animate the face, smile, speak, eat, and interact with society. “If you speak to those patients and see how they interact, they’re all exceedingly happy with their outcome,” he said.

“Pretty much all of them, just because of the nature of the complex tissue, have episodes of rejection where you have to increase their meds, at least for a temporary basis, to allow that to be tolerated. That’s one of the things that we always have to keep mindful of. Just getting the operation completed, getting that patient out a couple years, where they have a functioning face, where they can re-engage with society 85

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The Year in Veterans affairs & military medicine

and have that more meaningful existence, I think that’s one that matter, who have a defect that can’t be fixed readily by thing. That’s the feel-good piece,” Martin said. conventional means.”

The second piece, he pointed out, is the long-term followWhen asked about the biggest future challenges regarding up. “You have to make sure that that patient always has a these innovative procedures, Martin said, “I think funding place that they’re going to be evaluated such that if they have will be, as we’re ending wars and drawing down the budget these episodes of acute rejection, they’re seen promptly [and] of the military. Paying for weapons systems and machines, can be treated. Just doing the operation and the initial round troop levels, those are one thing. But when you look at how of medicines is one thing, but we can’t forget that this is a the funding pie is going to be divided, I think the easy, lowlifetime of vigilance. You can imagine the military patient hanging fruit are some of these research initiatives.” He who has one of these operations done, and then they exit the emphasized the need to “really state our case well and show military, then they’re in the VA system, so we all have to work the positive benefit of the DOD and government funding for together to make sure this isn’t just an active military compo- this research and these initiatives.” nent; to make sure that that patient can be taken care of for a “Through financial support is how a lot of breakthroughs lifetime, either through the VA or through civilian centers.” 1 happen,” he continued. “I think if we reduce funding, my fear Although research is ongoing, Martin sees a solution to is we’re going to lose some of the gains we’ve gotten, certainly the immunosuppression issue realistically as a long-term not push it down the road any further, so I’m hoping that that prospect. “I don’t think in the will not be curtailed to a significant next three to five years we’ll have degree. I think the science is there. I solved the puzzle,” he said. “The think we have to keep it in front of body’s immune system is a fanus to make sure we don’t ignore the ■■ “Just doing the tastic, complicated system for a gains we’ve already made.” operation and the very good reason, because it’s so Martin said it’s impossible to initial round of vital for us being able to live in a foresee when the first wounded warhostile world. To be able to solve a rior will receive a face transplant. “I medicines is one complex puzzle like that through can’t imagine predicting if it’s going to thing, but we can’t a single breakthrough, I don’t be six months from now or one year forget that this is a anticipate that is going to happen. from now or two years from now,” he But I think with continued said. “Certainly it’s going to happen.” lifetime of vigilance.” focused research, scientists will Martin expressed that one of get better about trying to unlock the most extraordinary aspects of some of the mysteries and make working with wounded warriors that a more acceptable answer.” who are two-, three-, and fourMartin also said the establishment of regional registries for limb amputees is to witness their spirit and what they will patients and donors, so that traveling great distances to an iso- go through every day to heal and recover. One of the initial lated center isn’t their only option, combined with increased questions was, “Will that injured soldier or Marine continue public awareness of the need for face and hand transplantation with his active rehab, which is very painful and very arduous, donors, are significant factors to advance these innovations. knowing that he could have a near-magical hand transplanMartin again emphasized that these government-funded tation one day? Will he try to work with his prosthetics; will initiatives will help both military and civilian populations. he do his therapy?”

“Nothing really happens in a vacuum,” he said. “One of the “The surprising answer is absolutely yes,” he continued. misconceptions that a lot of folks have is looking at military “Even though they have these potentially miraculous things, medicine as some isolated branch of science and civilian to watch those guys go through their physical and occupamedicine being something entirely different. [Because] all tional therapy and to go through the arduous journey of plastic surgeons in the military train in civilian [centers], using these prosthetics that are difficult to master but are we have that kind of cross-pollination and exchange of very effective, there’s no give up in these guys … You can’t ideas and cultures. And especially in this scenario where imagine a more deserving population to work for.” n a lot of the funding for face and hand transplantation is coming from government, DOD, and military dollars, the 1. There is an HA (Health Affairs) policy regarding participation of ADSMs (Active military and the government are very interested in this Duty Service Members) in non-cancer clinical trials such as those for face transbecause it could be a way to repair some of the war trauma. plants. The NDAA (National Defense Authorization Act) provision that allowed Secondarily, we’re creating some potential candidates for retirees to have access to this benefit has “sunset,” so they are no longer eligible.

A supplemental health care program waiver would need to be submitted and enthis technology. If we can make it happen for some of these dorsed by the member’s service and approved by Assistant Secretary of Defense horrific injuries that happen around wartime, that’s all the for Health Affairs Dr. Jonathan Woodson. Face transplants are not a TRICAREbetter for civilian trauma patients, or cancer patients for covered benefit so would not be available to non-active duty beneficiaries.

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The Year in Veterans affairs & military medicine

â– â– Based on photomicrographic data, this illustration depicts the ultrastructural morphology exhibited by a single Gram-positive Clostridium difficile bacillus. Clostridium difficile is a spore-forming, anaerobic bacillus that produces two exotoxins: toxin A and toxin B. It is a common cause of antibiotic-associated diarrhea (AAD).

It accounts for 15 to 25 percent of all episodes of AAD. Over the past several years nationwide, states have reported increased rates of C. difficile infection, noting more severe disease and an associated increase in mortality.

C. difficile infection remains a disease mostly associated with health care (at least 80 percent). Patients most at risk remain the elderly, especially those using antibiotics.

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The Year in Veterans affairs & military medicine

Health Care-acquired Infections: A New Threat Emergent Clostridium difficile is now public enemy No. 1 in the fight against HAIs

CDC image by Jennifer Hulsey

By Craig Collins n In January 2014, the transmission and Neither the military nor veteran health care systems have infection rates for health care-acquired methicillin-resis- been shielded from these increases; studies have shown that tant Staphylococcus aureus (MRSA) – a difficult-to-treat bac- C. diff has surged among both active duty and veteran popterial infection that had become a significant cause of ill- ulations. The dramatic rate of increase can be explained by ness, and occasionally death, in health care settings – were several factors that make it unique among HAIs. First, its continuing to decrease throughout U.S. medical facilities, onset coincides with the emergence of a particularly viruincluding those of the Department of Veterans Affairs (VA) lent and antibiotic-resistant strain (known among epideand military health care systems. miologists as the NAP1/ BI/027 Among VA medical centers, strain) around 2001. the decline was due largely to the “C. diff is now the the most freorganization’s MRSA Prevention quently diagnosed health care■■ About 25 to 30 percent Initiative, launched in 2007, a proassociated infection,” said Dr. of patients who are gram that placed a MRSA prevenDale Gerding, a research physician infected with C. diff tion coordinator at each medical at Chicago’s Hines VA Medical center, screened every VA patient Center (VAMC) and a professor will become infected at for MRSA, imposed strict protecin the Department of Medicine of least once more. Nearly tive and hygienic protocols for Loyola University Chicago Stritch all surface sanitation health care workers, and promoted School of Medicine. “Certainly individual responsibility for infecthis new epidemic strain, and methods used in the tion control. the much more severe, and more health care setting, But just as MRSA was declining, readily transmitted, disease in except for diluted bleach, infection rates for another drughospitals is probably behind that. resistant health care-acquired Plus, there have been a lot of are ineffective in killing infection (HAI) were on the rise efforts to target MRSA in hospithe organism’s spores. throughout the United States: tals with processes to screen for Clostridium difficile, a cytocarriage and isolate patients. So toxic bacterium of the gut and a it may be that we’ve made some major cause of diarrhea and colitis among infected patients. progress on MRSA but we’re struggling with C. diff.”

According to the U.S. Centers for Disease Control and The epidemic strain of C. diff is both more difficult to control Prevention (CDC), hospitalizations for the organism com- than many other pathogenic microrganisms, and more likely monly referred to as C. diff have tripled over the last decade, to recur in a patient, because of how it reproduces. As Deputy and the diarrhea caused by its toxins (enterotoxins A and B) Assistant Secretary of Defense for Health Services Policy now kills about 14,000 Americans annually. and Oversight Dr. Warren Lockette pointed out: “Clostridia

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89

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■■ The first line of defense in the fight against C. difficile and other HAIs is strict adherence to patient safety and quality control protocols.

are spore-producing bacteria like anthrax is. They have very interesting physiology. These spores can live in the environment for a long period of time. And that may be how people get repetitively colonized with them.” About 25 to 30 percent of patients who are infected with C. diff, said Gerding, will become infected at least once more. Nearly all surface sanitation methods used in the health care setting, except for diluted bleach, are ineffective in killing the organism’s spores.

Another singular characteristic of C. diff is that it appears to be present, at least part of the time, in a healthy human gut.

For reasons that are not fully understood – but which are the subject of numerous investigations – the presence of other bacteria in what’s knows as the “microbiome” of the intestine keeps C. diff in check; it’s only when it proliferates more rapidly than its neighbors that C. diff becomes pathogenic. For this reason, most C. diff infections are connected with medical care – in particular, treatment with broad-spectrum antibiotics that kill off other enteric bacteria – and infection risk generally increases with age. More than 90 percent of U.S. C. diff deaths happen to people 65 or older.

It is this last characteristic, said Gerding, that makes C. diff – while not more prevalent among military or veteran hospitals – a riskier disease overall for the veteran population.

“The immune system probably does wane as you get older,” he said, “And this potentially could be a factor that makes older people more susceptible to C. diff, because part of the

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protection against the disease is antibodies that circulate in the blood against the toxins that C. diff makes.”

The Battle Plan

The fight against C. diff is no different, essentially, than the fight against other HAIs; the most obvious requirement is strict adherence to existing patient safety and quality control protocols, to keep C. diff spores away from patients and reduce the likelihood of infection.

In addition, said Lockette, the idiosyncrasies of the C. diff organism make it even more crucial for physicians to be careful with antibiotics. “We need to focus on making sure we reduce the non-judicious or indiscriminate use of antibiotics,” he said, “because I think there is general consensus that indiscreet use of antibiotics, or overuse of antibiotics, has led to C. difficile bacteria becoming resistant to the agents we normally use to treat them.”

The risks for C. diff are generally greater among the patient subgroups more likely to be treated with antibiotics – those with spinal cord injuries, for example, who often undergo invasive procedures or treatments that increase the risk of infection. At the Hines VAMC, where Dr. Charlesnika Evans co-directs the VA’s Spinal Cord Injury Quality Enhancement Research Initiative (SCI-QUERI), studies have shown that 91

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■■ The idiosyncrasies of C. diff make antimicrobial stewardship crucial.

antibiotic use is the leading risk factor for the recurrence of a C. diff infection for veteran patients with an SCI. “So we’re really trying to develop research projects that focus on improving antimicrobial stewardship,” said Evans, “and stewardship can mean several things: It can mean decreasing the use of antibiotics overall. It could be managing patients in a different way, going from more broad-spectrum antibiotics that kill everything – but also promote antibiotic resistance – to moving to more narrow-spectrum antibiotics, which are really focused on a particular type of microorganism.”

In the longer term, the developing knowledge of the human microbiome may offer a significant option for treatment, and perhaps even a cure. A Dutch study of C. diff patients, reported in the New England Journal of Medicine in January 2013, compared two treatments among patients with C. diff-associated diarrhea: One group was treated with both vancomycin and the transplant of donated feces into their bowels; the other groups were treated either with vancomycin alone or with vancomycin and bowel lavage. Among the 16 patients receiving fecal transplants, 15 had resolution of C. diff-associated diarrhea. “They stopped the study early,” said Lockette, “because they felt it was unethical to proceed, given how much more effective the fecal transplants were at relieving C. difficile infection … When you give someone a fecal transplant, you’re giving them a microbiome that presumably has more of the healthy microbes in it and it allows the healthy microbes that are being transplanted to overtake the C. difficile microbes in the ill patient.”

Despite such startling promise, approval of fecal transplants by the Food and Drug Administration (FDA) as a treatment for C. diff isn’t about to happen; investigators can show

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that it works, but they still have no idea why. “The problem,” Lockette said, “is that you don’t know which bacteria you’re transplanting is the good bacteria, the one that suppresses the C. difficile. When you take a probiotic, you’re taking a specific good bacteria, also, but you don’t know if it’s the right good bacteria that will suppress the C. difficile.”

Equally promising – and closer to FDA approval for clinical use – is Gerding’s research at the Hines VAMC, which has focused on preventing relapse in C. diff patients by displacing the toxigenic organism with a non-toxigenic strain of C. diff that already exists in nature. “They’re out there circulating around, just like the toxin-producing strains are,” he said.

“We’ve been able to show in both animal and human models that when patients have these strains in the gut, they don’t get sick with the toxigenic strains.” In a phase 2 clinical trial, Gerding’s team showed that patients who received oral doses of non-toxigenic C. diff – about 10 million spores a day, for a week – were colonized with the harmless strain, blocking a recurrence of the disease in more than 90 percent of the subjects.

Gerding’s procedure is one of the most exciting developments to emerge from the VA’s research program in recent years, and at the beginning of 2014, he was awarded the William S. Middleton Award for outstanding achievement in biomedical research, the highest achievement awarded by the VA’s Biomedical Laboratory Research and Development Service. The procedure has one more hurdle to clear – a phase 3 clinical trial, for final confirmation of safety and efficacy – before it’s eligible for FDA approval, but it’s a treatment that could make toxigenic C. difficile far less threatening to patients receiving medical care. n 93

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Post-traumatic Stress Disorder and Traumatic Brain Injury n Post-traumatic stress disorder (PTSD) has days, and structural brain imaging yielding normal or become the most prevalent medical diagnosis of this century abnormal results. and among veterans of past wars, some of whom were origi- • Penetrating TBI is one in which the dura mater – the outer nally classified as suffering from shell shock, war neurosis, layer of the system of membranes enveloping the central soldier’s heart, effort syndrome, battle exhaustion, combat nervous system – is penetrated; penetrating injuries can fatigue, acute stress disorder – and, unofficially, in the first be caused by high-velocity projectiles or objects of lower half of the 20th century, cowardice. As such, it sometimes led velocity, such as knives or bone fragments from a skull to execution during World War I and dishonorable discharge fracture that are driven into the brain. and loss of veteran’s benefits during World War II. PTSD and TBI often are linked with each other and with Serious research and the designation of PTSD as a combat other combat injuries; as such, they are referred to as “polyinjury really began when it was first listed in the Diagnostic trauma” – two or more injuries to organs or parts of the and Statistical Manual of Mental Disorders, 3rd Edition body that create potentially life-threatening injuries and/ (DMS-III) (1980), but it has become the subject of a wide or disruption to physical, mental, and psychological funcrange of proposed causes, interactions with other neural tioning. According to a 2013 report published by the National functions, and treatments – some conInstitutes of Health (NIH): tradictory, many controversial.

“Prior studies have identified TBI, ■■ “Anyone who Traumatic brain injury (TBI) is conPTSD and pain to be the major comorbid sidered one of the “signature” inju[one or more disorders or diseases cohas witnessed the ries of the past 13 years of combat in occurring with a primary disease or diseffects of memory Southwest Asia, but veterans from preorder] elements most frequently seen in loss in another vious eras also are now being reviewed those previously deployed to Iraq and for possible TBI as knowledge about it Afghanistan who return with polytrauma. person knows its continues to grow. Basically, TBI can This constellation of comorbidities has toll and how few be caused by anything from a bump been referred to as the ‘polytrauma triad.’ options are available on the head to the severe concussive Investigators have noted that among [serforce of a nearby explosion. According vice members] treated at an in-patient to treat it.” to a Congressional Research Service polytrauma rehabilitation unit within report on military casualties from the the VA [Department of Veterans Affairs], Gulf War, the Department of Defense (DOD) categorizes TBI 80-to-93 percent were diagnosed with TBI, 81-to-96 percent cases as mild, moderate, severe, or penetrating: with pain, and 44-to-52.6 percent with a mental health disorder.

• Mild TBI is characterized by a confused or disoriented “Those with deployment-related difficulties from Operation state lasting less than 24 hours, loss of consciousness for up Enduring Freedom (OEF), Operation Iraqi Freedom (OIF) to 30 minutes, memory loss lasting less than 24 hours, and and Operation New Dawn (OND – U.S. military operations structural brain imaging that yields normal results. in Iraq after September 2010) receiving care in VA outpatient • Moderate TBI is characterized by a confused or disori- polytrauma programs were diagnosed with three or more postented state that lasts more than 24 hours, loss of conscious- concussive (TBI) symptoms 67-to-97 percent of the time, comness for more than 30 minutes – but less than 24 hours – plained of persistent pain issues 82-to-97 percent of the time memory loss lasting greater than 24 hours but less than and were diagnosed with PTSD 68-to-71 percent of the time.” seven days, and structural brain imaging yielding normal While the number of OEF/OIF/OND veterans diagnosed or abnormal results. with TBI, PTSD, or both has been substantial, from fiscal • Severe TBI is characterized by a confused or disoriented year 2009 through FY 11 only 9.6 percent (58,885) of veterans state that lasts more than 24 hours, loss of consciousness treated by the VA were diagnosed with TBI in at least one for more than 24 hours, memory loss for more than seven of those years. A higher number – 29.3 percent or 179,723 94

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Department of Defense photo by U.S. Air Force Tech. Sgt. Michael R. Holzworth

By J.R. Wilson

The Year in Veterans affairs & military medicine

■■ Marines with 3rd Battalion, 2nd Marine Regiment, 2nd Marine Division, complete a Post-Deployment Health Reassessment (PDHRA) survey in a mobile screening unit from the Deployment Health Center aboard Camp Lejeune, North Carolina. The infantry battalion was the battalion landing team for 22nd Marine Expeditionary Unit and recently returned from a humanitarian assistance operation in Haiti. Marines and sailors of 3/2 were completing their PDHRA after returning from an operational deployment.

– was diagnosed with PTSD during that same period, while the full polytrauma triad (including head, neck, or back pain) was diagnosed in 6 percent (36,800). However, DOD reports more than 80 percent of the 300,000-plus service members who have sustained a traumatic brain injury since 2000 were in a non-deployed environment at the time.

Despite those numbers, the NIH report adds it is impossible to accurately quantify the incidence of TBI – or, to a lesser extent, PTSD – in the veteran population because some of the numbers were based on self-reported cases, which “may overestimate the rate of TBI compared with clinical assessment, just as they have been found to overestimate the rate of PTSD relative to gold standard interviews. On the other hand, clinical assessment is also subject to error and, in fact, these medical diagnoses may be under-reported in VA records.”

“In sum, while our findings describe the proportion of OIF/ OEF/OND veteran VA users with TBI diagnosis in the VA FY2009–11 administrative data, they may not describe the actual incidence of TBI or the impairment or disability related to TBI in the population of all OIF/OEF/OND veterans,” the report concluded. It added, however, that the three-year investigation did demonstrate the wide extent of such cases among new Gulf War veterans, with the number turning to the Veterans Health Administration (VHA) for health care growing substantially.

“This investigation represents the first multiyear, systemwide analysis of TBI, mental health and pain-related

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comorbidities and triad diagnostic trends from the VHA …

Among those with a TBI diagnosis, the majority had a clinician-diagnosed mental health disorder and approximately half of those with TBI had both PTSD and pain. Overall, while the absolute number of OIF/OEF/OND veterans increased by over 40 percent between FY2009 and FY2011, the relative proportion of veterans diagnosed with TBI and the high rate of comorbid PTSD and pain in this population remained relatively stable.”

Part of the data used came from a mandatory screening for TBI implemented by the VA in April 2007 for all OEF/OIF veterans during their first visit to the VA. While exact numbers – even exact diagnoses – remain elusive, the confirmed high incidence of both TBI and PTSD, especially among ground forces, has been a driving factor in efforts to better understand, diagnose, treat, and even prevent brain injuries and related health problems in combat.

The DOD and VA efforts in this regard are working closely with civilian researchers who have been focused on concussive injuries among athletes, especially football and soccer players, boxers, and martial artists who experience repeated blows to the head. It also has application to injuries sustained by children at play – or resulting from abuse – and those injured in automobile or other accidents.

This emphasis, however, also has resulted in a plethora of claims and counterclaims, from legitimate researchers and 95

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GeneSight testing is available for patients with neuropsychiatric conditions including PTSD, depression, anxiety, bipolar disorder, schizophrenia, and other behavioral health conditions. It was developed in the Assurex Health clinical laboratory and is based on patented technology licensed from Mayo Clinic and Cincinnati Children’s Hospital Medical Center, who continue to be research collaborators.

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1. Trivedi MH, Rush AJ, Wisniewski SR, et al; for the STAR*D Study Team. Evaluation of the outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006;163:28-40. 2. Hall-Flavin DK, Winner JG, Allen JD, Carhart JM, Proctor B, Snyder KA, Drews MS, Eisterhold LL, Geske J, Mrazek DA. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenetics and Genomics. 2013;23(10):535-548.

The VA did not select or approve this advertiser and does not endorse and is not responsible for the views or statements contained in this advertisement. ©2014 AssureRx Health, Inc. All Rights Reserved. All registered trademarks are the property of their respective owners. Assurex Health is a DBA of AssureRx Health, Inc.

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images courtesy of Lawrence Livermore National Laboratory

■■ LEFT: Lawrence Livermore engineer Vanessa Tolosa holds up a silicon wafer containing micromachined implantable neural devices.

The implantable neural interface will record from and stimulate neurons within the brain for treating neuropsychiatric disorders. RIGHT: This rendering shows the next-generation neural device capable of recording and stimulating the human central nervous system being developed at Lawrence Livermore National Laboratory. The research is funded by DARPA’s Restoring Active Memory (RAM) program.

physicians to scam artists hoping to make a quick profit from those desperate for help and confused by the state of treatment. Even legitimate health care givers are struggling to find the best answers among all the claims – good, bad, and criminal – coming out almost every day.

For example, a listing of articles about brain injury by the Centre for Neuro Skills had links to more than 200 articles, from scientific journals to the popular media, for the first eight months of 2014 alone – excluding those specifically related to sports or children. The topics listed ranged from “Blueberries Could Help Heal Brain Injuries” to “Cortisol and Progesterone Levels and Outcomes Prediction after Traumatic Brain Injury.”

In January 2014, the Defense and Veterans Brain Injury Center (DVBIC), the TBI operational component of the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, released a first-of-its-kind set of guidelines – “Progressive Return to Activity Following mTBI Clinical Recommendations” – tailored for primary care managers and rehabilitation providers.

“These recommendations will further improve and standardize the care provided to patients with mild TBI [mTBI] and offer them useful information to become more actively involved in their recovery,” Director, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury Capt. Richard F. Stoltz (USN) said.

In July 2014, the Defense Advanced Research Projects Agency’s (DARPA) Biological Technologies Office announced a new TBI program called Restoring Active Memory (RAM), with the University of California, Los Angeles (UCLA), and the University of Pennsylvania each leading a multidisciplinary

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team to develop and test wireless, implantable “neuroprosthetics” to help service members, veterans, and others overcome memory deficits resulting from TBI or disease. DARPA also is working with Lawrence Livermore National Laboratory to develop an implantable neural device for the UCLA-led effort.

Despite the scale of the problem, no effective therapies currently exist to mitigate the long-term consequences of TBI on memory, according to DARPA, and their goal is to use RAM to accelerate development of technologies to address the problem by developing new neuroprosthetics to bridge gaps in the injured brain.

“We owe it to our service members to accelerate research that can minimize the long-term impacts of their injuries,” DARPA Program Manager Justin Sanchez, Ph.D., said.

“Despite increasingly aggressive prevention efforts, traumatic brain injury remains a serious problem in military and civilian sectors. Through the RAM program, DARPA aims to better understand the underlying neurological basis of memory loss and speed the development of innovative therapies.”

RAM is one of many efforts underway – within the military and VA, as well as civilian medical research and academia – to deal with TBI and PTSD by aggressively pushing the envelope of understanding about one of the most challenging of human mysteries – the brain. DARPA’s plan calls for developing multiscale computational models with high spatial and temporal resolution that describe how neurons code declarative memories – “welldefined parcels of knowledge that can be consciously recalled and described in words, such as events, times and places.”

The program also includes foundational efforts to analyze and decode neural signals to determine how targeted stimulation 97

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U.S. Army Photo by Lisa Ferdinando, army news service

■■ Army Surgeon General Lt. Gen. Patricia D. Horoho speaks at the beginning of a two-day Brain Health Consortium at the Defense Health Headquarters in Falls Church, Virginia, April 10, 2014.

might help an injured brain re-establish the ability to encode or process new memories. The resulting computational models then will be integrated into new, implantable, closed-loop systems able to deliver targeted neural stimulation, with an aim toward ultimately helping restore memory function.

The UCLA team’s effort includes a unique focus on the brain’s entorhinal area, which university researchers previously found could be stimulated to facilitate learning and turning daily experiences into lasting memories. The goal is to develop an advanced, new wireless neuromodulation device, one-tenth the size of existing test items, but with far greater spatial resolution, that ultimately can be implanted into the entorhinal area and hippocampus of TBI patients.

The Pennsylvania team, meanwhile, is focusing on the relationship between memory and complex interactions among widespread regions of the brain. Neurosurgical patients who have had electrodes implanted in multiple areas of their brains as treatment for various neurological conditions, will play computer-based memory games while researchers measure biomarkers of activity patterns stemming from successfully forming new memories and retrieving old ones. The goal is to use the results as models in creating a novel neural stimulation and monitoring system, in partnership with Medtronic, to restore brain memory function.

“The start of the Restoring Active Memory program marks an exciting opportunity to reveal many new aspects of human memory and learn about the brain in ways that were never before possible,” Sanchez said. “Anyone who has witnessed the effects of memory loss in another person knows its toll and how few options are available to treat it. We’re going to apply the knowledge and understanding gained in RAM to develop new options for treatment through technology.”

In her opening remarks to the Brain Health Consortium at Defense Health Headquarters in April 2014, Army Surgeon General Lt. Gen. Patricia D. Horoho called brain health both the “new frontier” in science and a central focus of military health and medicine, for the benefit of warfighters’ military and civilian lives, their families, and the nation as a whole.

“Ultimately, the decisions made by the brain impact our overall health and also our well-being,” Horoho said. “The brain, through our daily decisions, becomes the gatekeeper of the health and fitness of our bodies.”

Implanting computer chips or devices inside the human brain is one of the most controversial ideas for treatment – even beyond those doctors and veterans advocating the use

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of marijuana to reduce symptoms related to PTSD. But while DARPA’s approach is revolutionary, more than 100,000 individuals already have deep brain stimulating implants to help them with Parkinson’s disease and dystonia. RAM is unique in its focus on specific brain interfaces to restore memory function.

Even so, Dr. William Casebeer, a program manager in DARPA’s Defense Sciences Office, said the agency has developed a process called the “Three Cs Framework” – character, consent, consequence – that examines ethical and moral issues arising from neurotechnology developments.

“The idea of evaluating character-oriented dimensions of technology really is an ancient one that stems from Aristotle and Plato and their examination and articulation of virtue theory,” he said. “If we examine those three Cs I think, along all three of them, we see a lot of support for exactly the kind of technology development that Dr. Sanchez will be pursuing in the RAM program.”

Veterans diagnosed with TBI are not the only ones for whom help is being sought by DOD and the VA; new programs also are being developed for their families.

DVBIC’s 15-year longitudinal studies are integrating a collection of research examining the effects of TBI on the families of service members and veterans who suffered traumatic brain injuries in Iraq and Afghanistan. Within that program, which studies the long-term effects of TBI for up to 15 years after the injury, the “Caregiver Study” observes the overall health and well-being of family members caring for a service member or veteran with TBI to identify factors that can improve caregivers’ quality of life.

“For caregivers, deployment places a strain on the family,” said Dr. Louis French, the Longitudinal Study’s principal investigator. “The Caregiver Study portion of the 15-year study will allow us to gain a better understanding of how much additional burden is placed on the family dynamic with an injured loved one. For example, does the family need more medical care themselves or are they in emotional distress? This study will provide valuable input about the need for additional resources, inefficient allocation of resources, or other key information from this under-examined group.”

Throughout history, war has led to major improvements in technology and knowledge. Since the start of the 20th century, those advances often have taken medicine and science to new levels previously found only in science fiction. So far, the 21st century has set a new standard for such developments, from prosthetics to computers to robotics – and, now, the human brain.

“This is a truly remarkable period of time,” Sanchez said.

“To think about how we are going to learn about memory in the human brain, to think about the potential for developing those next-generation medical neuroprosthetic devices that can provide new options for our injured military personnel, is truly remarkable.” n 99

The Year in Veterans affairs & military medicine

Better Treatments, Better Outcomes for Veterans with Hepatitis C VA is on the leading edge of Hepatitis C care.

By Craig Collins n In 1989, when hepatitis C virus (HCV) was of nonveterans who don’t know they’re infected is significantly confirmed as a distinct genus of disease-causing virus, it was higher than in the VA system. Many people are just not tested. already known that thousands of American veterans had been The VA has really been a leader in testing for hepatitis C – it’s infected with the disease. The discovery marked the onset of been our testing program, for example, that has shown us that the VA’s hepatitis C program, perhaps the nation’s most com- Vietnam-era veterans have a much higher rate of HCV infecprehensive integrated system of HCV care and research. tion compared to non-Vietnam-era veterans.”

A communicable disease passed almost entirely through Guidelines developed by the CDC and the independent blood-to-blood contact, hepatitis C is fought off success- U.S. Preventive Services Task Force indicate HCV testing for fully in the “acute” phase – the first anyone with a risk factor for the dissix months after infection – by about ease (i.e., intravenous drug use or a 15 to 40 percent of those infected. history of blood transfusion prior to ■■ The U.S. Centers The remainder of those with HCV 1992); anyone who specifically asks to enter the “chronic” phase of the disbe tested; and “baby boomers” born for Disease Control ease, a persistent state in which the between 1945 and 1965. and Prevention virus occupies the liver, inflaming “At this point, the VA has tested (CDC) estimates that and scarring it over a period of about two-thirds of people in that baby years. Twenty-five percent of chronic boomer cohort,” said Dr. David Ross, there are 20,000 hepatitis patients will develop the director of the VA’s HIV, Hepatitis, new HCV infections advanced liver disease known as cirand Public Health Programs. “That’s every year. rhosis, which in turn can develop into compared to probably less than 50 life-threatening conditions such as percent for the country as a whole. liver failure and liver cancer.

So we’ve identified and diagnosed a Because these conditions often take substantial proportion of the patients years, even decades to manifest – and because most of those in the VA who have hepatitis C. But we want to try and test with chronic hepatitis C develop liver disease slowly enough everybody, or at least offer testing to everybody, who is in that that it never becomes a major issue – many Americans with baby boomer cohort.”

HCV are unaware they’re infected. The U.S. Centers for Ross estimates that there may be 30,000 to 40,000 more Disease Control and Prevention (CDC) estimates that there patients in the VA system who have hepatitis C but don’t are 20,000 new HCV infections every year. know it yet – and identifying these patients will help the VA According to Dr. Jack Stapleton, a physician with Iowa City achieve better “secondary” prevention: keeping infected vetVA Health Care System and professor of internal medicine at erans from developing complications, or from transmitting the University of Iowa College of Medicine, “The proportion the disease to others.

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The Year in Veterans affairs & military medicine

123RF Stock image by Sebastian Kaulitzki

■■ Chronic hepatitis C virus (HCV) attacks the liver over years or decades. Of the chronic-phase HCV patients VA had monitored as of 2012, 25 percent had developed cirrhosis.

Improving Treatment Outcomes

With no HCV vaccine, nor any promising candidate undergoing trials, Ross said the primary prevention efforts of the VA and other public health agencies have focused on educating patients about the most common means of exposure to infected blood, such as injection drug use. These exposure routes are now widely known, he said: “Hepatitis C is much more a treatment problem now than a prevention

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problem for the VA.” In 2012, the most recent year from which data is available, 173,000 VA patients tested positive for chronic hepatitis C; about a quarter of them, Ross said, have developed cirrhosis. Overall, the VA provides care and treatment for the greatest number of HCV-infected people in the nation.

For years, the standard therapy for hepatitis C has been a cocktail of antiviral medications, typically anchored by pegylated interferon and the drug ribavirin.

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The Year in Veterans affairs & military medicine

va photo

■■ A veteran having blood drawn for testing.

The VA has been a leader in testing for hepatitis C, and is working to test all veterans born between 1945 and 1965.

The standard “peg/riba” therapy, said Ross, is a grueling ordeal for many: “Patients will feel awful,” he said. “They feel like they’ve got a bad flu. And given that the treatment lasts for up to a year, a lot of patients can’t tolerate it. There are also other side effects. People get depressed and sometimes suicidal. I have a number of patients who just refuse treatment because they’ve said, ‘It’s not worth it to me.’”

Patients with mental health issues are among those for whom the peg/riba treatment is often contraindicated, but they’re not the only ones to whom it poses risks.

“People who have anemia at baseline can have severe anemia when ribavirin is administered and have to be monitored closely,” said Dr. Donald Anthony, a physician with the Cleveland VAMC and associate professor of medicine at Case Western Reserve University. “Some individuals have renal insufficiency or kidney dysfunction, and that makes things even more difficult, because the ribavirin is hard to dose in those individuals. So we do have a long track record of difficult situations where we’re unable to treat patients with interferon or ribavirin as we would like.”

Among those who are able to endure peg/riba and a direct acting antiviral agent combination therapy, about 50 to 80 percent are cured – the virus cleared from their bodies. The number whose infections persist, in addition to those for whom peg/riba is contraindicated, continue to comprise a significant fraction of people who continue to struggle with hepatitis C. VA’s physicians and research scientists have led the way in searching for better hepatitis C treatments, in improving veterans’ access to these therapies, and in improving outcomes for patients who seek treatment. VA research ranges from basic molecular and biomedical studies of the hepatitis C virus to the overall effectiveness of VA’s systems of care.

In Cleveland, for example, researchers are conducting biomedical studies aimed at understanding the role of natural killer cells in fighting HCV infection, as well as clinical studies designed to explore why certain populations, such as the elderly, have worse clinical outcomes. In Iowa City, Stapleton and associates are engaged in vaccine-related research, exploring ways to modify HCV proteins that block or weaken the human immune response. Throughout the VA health system, health services researchers are conducting investigations designed to hone and customize therapies to individual circumstances, such as viral genotype (there are

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seven HCV genotypes), behavioral issues (such as chronic alcohol use, which reduces treatment effectiveness), or medical or mental health variables such as anemia or depression.

VA research has shown, for example, that anemic patients can still benefit from treatment.

“The VA has been a leader,” said Stapleton, “in the research showing that the integrated care system, with an infectious disease or hepatology provider having nursing support and social and psychological support, improves outcomes.”

Since 2001, guidance and outreach – for both providers and patients – has been provided through the VA’s four Hepatitis C Resource Centers, located in West Haven, Connecticut; Minneapolis; San Francisco; and Seattle. “Their job,” said Ross, “has been to provide educational resources for clinicians, standards, and treatment guidelines. They are also tasked with developing new models of care, ways of trying to make care more effective.” The VA is in the process of combining these centers into a single virtual center, whose expertise will be accessible from anywhere in the country.

“We want to have people at different locations contribute to things,” said Ross, “because there is a lot of variation in practice patterns across the system.”

A New Era in Hepatitis C Treatment

VA researchers are also exploring the potential of a new class of drugs, polymerase inhibitors, which block a specific protein required to grow the hepatitis C virus. Polymerase inhibitors, which do not involve the kind of debilitating side effects associated with interferon, were approved for clinical use by the FDA in 2013.

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The Year in Veterans affairs & military medicine

One of these polymerase inhibitors in particular, sofosbuvir, is a once-daily pill used as part of an antiviral combination treatment targeting HCV genotypes 1 (which accounts for 70 percent of HCV cases), 2, 3, and 4. Sofosbuvir will allow some patients to avoid the need for weekly interferon injections. While patients with genotype 1 will still be treated with interferon, the course of treatment will be a considerably shorter 12 weeks.

The results from the first clinical trials of regimens involving sofosbuvir and other polymerase inhibitors mark the beginning of the end of the standard interferon-based therapy. “The preliminary data from small – but in aggregate, pretty significant – studies show that if you can combine two classes, and even three, much like we do with HIV therapy, you have very high cure rates,” said Stapleton. “Over 90 percent, even in people that we used to call the hard-totreat. As we move toward this interferon-free treatment as the standard, it will improve our cure rates – doubling them, for almost everyone who is able to take the therapy.”

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As of August 2014, the VA had begun about 4,300 hepatitis C patients on a regimen involving sofosbuvir, manufactured under the trade name Sovaldi by Gilead Sciences and another new drug, the protease inhibitor simeprevir.

Both drugs are incredibly expensive, at $1,000 a day. Ross estimates that by the end of fiscal year 2014, the VA will have spent nearly $300 million on the regimen. “The VA policy on both these drugs,” he said, “is that decisions should be made on clinical indication, not on cost.”

Being on the cusp of an interferon-free era in hepatitis C treatment, said Ross, is one of the most exciting times in his career. “I’ve been an infectious disease physician for over 20 years,” he said, “and I never thought I’d see the day when we’d have a cure for this disease. We really have a window of opportunity to do something about it, and I think my goal and the program’s goal is to try and get access to treatment for as many veterans as quickly as possible.” n

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Courtesy of Gilead Sciences

■■ While protease inhibitors and polymerase inhibitors like sofosbuvir are very expensive, the VA’s policy is that decisions should be based on clinical indication, and it had begun 4,300 hepatitis C patients on the drugs as of August 2014.