2011 - NIH Clinical Center - National Institutes of Health

PROFILE 2011There’s NoOther HospitalLike ItN I H C L I N I C A L C E N T E R • D I R E C T O R ’ S A N N U A L R E P O R TU. S. Department of Health and Human Services • National Institutes of Health

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PROFILE 2011There’s NoOther HospitalLike ItCONTENTS 20113 Message from the Director4 Mission/Vision6 Patient Activity and Support16 Advancing Clinical Research39 Training the Next Generation48 Organizational Improvement/Teamwork54 Noteworthy58 Organization and Governance

MESSAGE FROM THE DIRECTORHISTORIC OPPORTUNITIESThe Clinical Center underwent unprecedented scrutiny in 2010 as part of a thoroughreview of NIH’s intramural program by the Scientific Management Review Board.The Board was authorized by the NIH Reform Act of 2006 to advise the NIHDirector, HHS officials, and Congress. Recommendations made by the Board atthe end of 2010 included expanding the Clinical Center’s role as a resource for theexternal clinical research communities; streamlining its governance structure; anddefining a more stable mechanism for funding that is responsive to evolving priorities.These recommendations still face further discussion across NIH and HHS prior to afinal decision, which will be reported to Congress.The Clinical Center has made strides in opening its doors to extramural researchersin recent years.The Bench-to-Bedside program has included research collaborationsinvolving extramural investigators since 2006.A pilot partnership with the DamonRunyon Cancer Research Foundation, announced late in 2010, is a promising newavenue for external collaborations with early-career investigators.Training in clinicalresearch and its management has long been an important cornerstone of the ClinicalCenter’s mission. Since 1995, more than 21,000 students world-wide have participatedin the NIH Curriculum in Clinical Research. In 2010, the innovative sabbatical inclinical research management attracted its first participants.The sabbatical provides alearning environment that is totally flexible and responsive to student needs.The Clinical Center provides an unparalleled environment for all aspects of clinicalresearch.The coming months and years offer remarkable opportunities for the ClinicalCenter to contribute to medical discovery in important new ways.John I. Gallin, MDDirector, NIH Clinical CenterANNUAL REPORT 2011• 3

OUR VISION As America’s research hospital, we will lead the global effort intraining today’s investigators and discovering tomorrow’s cures.MISSION To provide a versatile clinical research environment enabling the NIH mission toimprove human health by:• investigating the pathogenesis of disease;• conducting first-in-human clinical trials with an emphasis on rare diseasesand diseases of high public health impact;• developing state-of-the-art diagnostic, preventive, andtherapeutic interventions;• training the current and next generations of clinical researchers; and,• ensuring that clinical research is ethical, efficient, and of highscientific quality.There’s No Other Hospital Like It4 • ANNUAL REPORT 2011

R E C E N TCLINICAL CENTER ACHIEVEMENTSI N 2010 WE:• Expanded the international reach of clinical research training programs.• Initiated a sabbatical in clinical research management.• Began a pilot partnership with the National Cancer Institute’s Center forCancer Research and the Damon Runyon Cancer Research Foundation,offering some of the Clinical Center’s capabilities and expertise to anexternal group of clinical investigators in cancer research.• Defined the nursing subspecialty in clinical research nursing.• Opened a new pharmaceutical development facility to formulate candidatedrugs and a Special Clinical Studies Unit offering state-of-the-artisolation and extended-stay capabilities.• Partnered with Project SEARCH to launch an internship program foryoung adults with disabilities. • Underwent review as part of the Scientific Management Review Board’sfocus on NIH intramural research. The Board, established by the NIHReform Act of 2006, advises the NIH Director and HHS officials on certainorganizational authorities.• Celebrated the fifth anniversary of the Edmond J. Safra Family Lodge.• Continued collaborations in the Undiagnosed Disease Program. Nearly400 patients have been accepted since the program began in 2008. • Improved communications with referring physicians.• Enhanced patient safety through expanded bar-coding capabilities.ANNUAL REPORT 2011• 5

Patient Activity and SupportHOME STATES OF ALL ACTIVE CLINICAL CENTER PATIENTS0-9991,000-7,9993,000 +NDWA MT 27363 85MN360MASDWI122OR24352228 ID MI113 WY 602 NY43 VT 63IA 1692NE 150NH 100140 PA MA 499IL IN OH 1943 RI 71NVUT CO 752 460 738CT 35097280 367 KS NJ 1016MOWV183348 KY 417DE 283VACA272 8933DC 46451306 MD 20,749OK TN NC220 AR 325AZNM110599315 119 SCMS AL GA 379146 198 598TXLA928254 Patients come to NIH fromevery corner of Americaseeking answers to theirAKFL scientific and medical quest ions.421362 Finding these answers throughleading-edge clinical researchis the sole mission of theHINIH Clinical Center, guiding80all of its activity.WORKFORCE DISTRIBUTIONNursing & patient care/supportservices 41%Administrative & operations 18%Clinical departments & imaging sciences departments 41%FY 2010 BUDGET BY MAJOR CATEGORY377.4 MILLIONSalaries and benefits 57%NIH assessments 7%Drugs 10% Contracts (labor) 8%Contracts (non-labor) 7%Equipment 3%Supplies 6%All other 2%The Clinical Center has a staff of approximately 2,000.6 • ANNUAL REPORT 2011

PAT IENT ACT IVITY 2008–2010Admissions 08 6,105 4.8% increase09 6,426 5.3% increase10 6,000 6.6% decreaseNew patients 08 9,460 0.3% increase09 10,315 9% increase10 P A 10,086 T I E N T A C T I V I T Y P A P A T- 2.2% decreaseInpatient days 08 51,311 0.2% increase09 55,664 8.5% increase10 56,502 1.5% increaseAverage length 08 8.5 1.5% decreaseof stay (days) 09 8.7 2.6% increase10 9.4 7.6% increaseOutpatient 08 90,254 0.7% decreasevisits 09 96,372 6.8% increase10 96,664 0.3% increaseONSITECLINICALACTIVITY FOR2006–2010Active 06 1,372Protocols 07 1,39008 1,44909 1,45110 1,443New 06 205Protocols 07 16608 15509 16210 158Principal 06 505Investigators 07 48408 47809 48110 474ANNUAL REPORT 2011• 7

PATIENT ART ON DISPLAYthe “Hope Flows from One to Another” displayon the Hatfield Building’s seventh floor. Next tothe wall of NIH Nobel Prize laureates, the patientartwork completes a representation of translationalresearch.A new display in the NIHVisitor Center andNobel Laureate Exhibit Hall in the NatcherBuilding spotlights Clinical Center partnersin research—the patients.Tiles from “The Artof Healing” art therapy project out of the CCRehabilitation Medicine Department RecreationTherapy Section and the CC Art Program wereinstalled in late February.The project was conductedin the summer of 2008 and invited patients andtheir family members to decorate tiles to expresstheir experiences through illness and treatmentusing mixed media like copper cut-out shapes,game pieces with letters, paint, and a texturizedmodeling paste. Many of the tiles are presented in“We so appreciate the addition of this patientfocusedexhibit. It adds a wonderful dimensionand balance to the other displays in the exhibithall that focus on the importance of researchers asmentors,” saidVisitor Center and Nobel LaureateExhibit Hall director Jennifer Gorman (at right inphoto with coworker Tara Mowery).“The patienttiles bring the human story of research to the audience.Theyliterally jump off the wall and say to theviewer that research and discovery is about life.”The art selection and arrangement of the work,with identifiable themes at eye-level, particularlyappeals to middle-school age groups who participatein programs at the NIH, Gorman said, thoughany kid at heart should be drawn to the tiles.TheVisitor Center plans to continue enhancingthe Nobel Laureate Hall’s aesthetic with interactiveconsoles where visitors can hear stories of discoveriesfrom the researchers who made them andexperience virtual tours and science that highlightthe NIH.FORMER PATIENT CELEBRATES LIFE AFTER BEATING CANCER AT THE NIHRobert Longo celebrated an anniversary in June 2010. Given a 20percent chance of living two years, Longo has survived 35 years aftera bone cancer diagnosis at age 15.He was diagnosed on June 10, 1975. Living in Rockville at the time,Longo learned of an NIH protocol for the cancer that would takehis left leg above the knee. Others in the study were also teenagersand together they did two legged races down the hall and played inwheelchair basketball games organized by the nurses.His experience as a research volunteer inspired his project to earn“life rank” in the Boy Scouts of America: a blood drive at the NIHBlood Bank. More than 100 people donated 92 pints of blood.Longo continues to organize NIH blood drives.8 • ANNUAL REPORT 2011

VOLUNTEER INTERPRETERS HELP STAFF AND PATIENTS BRIDGE LANGUAGE BARRIERSEileen DeSantillana (right) is one of more than70 language interpreter volunteers who helppatients like Jaime Sanchez of Oaxaca, Mexico,navigate the sometimes complicated journey ofclinical research. To assure that all patients have afull understanding of their involvement in clinicalresearch, and, conversely, to assure that staff havea full understanding of what the patient is experiencing,the CC relies on a dedicated staff oflanguage interpreters.The program also comprises three staff membersto handle the average of 25 (though as high as40) interpreter requests that come in a day. FromAmharic (spoken in Ethiopia) toYiddish, the programoffers interpreters in more than 40 languages.Volunteers come in the form of former and currentNIH staff, local retirees of such internationalentities as the World Bank and the Pan AmericanHealth Organization, and medical students orthose who wish to soon be such.“Our volunteersare selfless people who serve with devotionand humanity,” said coordinator Brenda Robles.“They value their experience and show respectto the patients.We admire them and highlyvalue them.”All volunteers are vetted and tested to assure thattheir capabilities match the CC needs, particularlyknowledge of medical and legal jargon, Roblessaid. No matter their background, applicants take awritten and an oral test then, if they pass, shadowan interpreter to learn the CC process.Nurse Eleftheria (Libby) Koklanaris of the NationalHeart, Lung, and Blood Institute uses the theservice almost daily to interpret for proceduresand consents and to communicate and correspondwith patients and their doctors in their countryof origin.“Without the Language Interpreter Program andtheir services, it would be challenging to advocatefor the patient’s needs, which does not do justicefor the patients,” Koklanaris said.“They offer manyservices and their endless efforts of advocacy andprofessionalism are what make them desired bymany.”ARTIST’S EYESChevy Chase artist Jean Meisel made agenerous donation to the Clinical Center in2010—13 large works, half of which hang inthe Magnuson’s Building new main corridor.Her artist’s statement explains her work:“Everyday of our lives we are astounded by the gloriousand mysterious objects and events in thenatural world. In my paintings I isolate shapesand colors and simplify what I see—rocks,leaves, skies, shells—in the hope that the viewer,like the painter, can apprehend these miracleswith new eyes.”ANNUAL REPORT 2011• 9

EDMOND J. SAFRA FAMILY LODGE MARKS FIFTH ANNIVERSARYThe Edmond J. Safra FamilyLodge has housed close to74,000 caregivers of ClinicalCenter patients since itopened on June 1, 2005. Itoffers convenience and communityto the loved ones ofour partners in research.A haven for caregivers of Clinical Centerpatients—the Edmond J. Safra Family Lodge—welcomed its first guests on June 1, 2005.Since then, about 74,000 family caregiversfrom around the world have stayed at theFamily Lodge.“The lodge was first conceivedby Clinical Center nurses, and having aresource like the Family Lodge was a goal ofmine for many years,” said Dr. John I. Gallin,CC director.“Patient volunteers make clinicalresearch and medical discovery possible.Thelodge makes it possible for their loved ones to stayclose and be comfortable during what canbe a very stressful time.”Just steps away from the CC, the 34-room guesthouse is an extension of the patient experience,said Denise Ford, chief of CC Hospitality Services.“We know how much our patients need the supportof their loved ones while they are inpatients.It gives them peace of mind to know that family isclose by and well cared for by our wonderful staffat the lodge,” Ford said.Getting hereThe CC initiated the NIH Guest Houseprogram in 1996 in Building 20, the former staffApartment House. Building 20 was torn down in1998 to make way for the Hatfield Building.The six-unit Guest House moved to a nearbyapartment building on Battery Lane in Bethesdathen to six rooms in a local hotel.These pilot programsdemonstrated the need for housing.The CCapproached the Foundation for the NIH, askingthat the foundation’s board spearhead a campaignto solicit support from private sector partners tobuild the Family Lodge.As the project closelyreflects its mission—supporting NIH’s efforts toimprove health through scientific discovery—the foundation board made fundraising for themuch-needed lodge its highest priority.On April 17, 2002, a ceremony marking thenaming of the facility as the Edmond J. SafraFamily Lodge was held at the Russell SenateOffice Building in Washington, DC.Massachusetts Sen.Ted Kennedy was a keynotespeaker in support of the lodge. Contributors ofthe $9 million raised to build the lodge, besidesthe main benefactor, the Edmond J. SafraPhilanthropic Foundation, included the MerckCompany Foundation; the Bristol-Myers SquibbFoundation; GlaxoSmithKline; the Harry andJeanette Weinberg Foundation; and many othercorporations, foundations, and individuals.Considered by many to have been the twentiethcentury’s greatest private banker, Safra quietlycarried out many philanthropic activities.TheEdmond J. Safra Philanthropic Foundation carriesforth Safra’s lifetime commitment to medical10 • ANNUAL REPORT 2011

esearch and humanitarian causes. His namesakeorganization gave millions to the Foundationfor the NIH. Safra’s wife, Lily, serves on thefoundation’s board of directors.A groundbreaking ceremony on October 29,2002, marked the beginning of construction of theFamily Lodge. It was designed by Amy Weinsteinof Weinstein Studio in conjunction with thearchitectural firm Louviere, Stratton andYokel.Designed in the unique style of an early 1900sEnglish Manor House, the lodge offers a retreatto the families and caregivers who make it theirtemporary home.Lily Safra, on making her gift for the building ofthe Family Lodge, said,“We know that whenillness afflicts one person, an entire family cansuffer.The mission of the Edmond J. Safra FamilyLodge is to give those families a place to remainresilient together.”On May 26, 2005, the six-year planning andconstruction project officially came to an endas the Family Lodge was formally dedicatedand opened.When Lily Safra saw the completedbuilding for the first time, she smiled and simplystated,“Beautiful.”How it worksGuests are offered a room at the Family Lodgebased on a priority system. Caregivers of patientsin the intensive care unit are given first priority,followed by those with loved ones in palliative orend-of-life care. Close to 70 percent of guests arefrom the third priority group: those accompanyinga patient having inpatient surgery or admittedfor more than one week.The remaining priorities are fordischarged inpatients (and theirguests) transitioning home andoutpatients (and their guests).The Family Lodge is located atthe corner of Convent and CenterDrives, across the street from the CC.“The proximity of the lodge to theClinical Center offers ease of access,”Ford said.“It gives them one lessthing to worry about and lets themfocus on caring for their loved one.”“Staff are customer service-oriented,but respect the guests’ privacy,” saidEdmond J. Safra Family LodgeExecutive Director LawrenceEldridge. Many want to reflect orrelax alone, while some guests maycare to engage with others, frequentlyin the lodge’s shared kitchen.Special garden settingThrough an additional specialgift to the Foundation forthe NIH made by Lily Safra,landscaping around the FamilyLodge offers visitors a myriadof garden experiences, includingthe more private Claudioand Evelyne Cohen Garden.A peaceful, tranquil venueprovides guests with a place ofrest and refuge from their dayto-dayconcerns in an Englishpark-like setting reminiscent ofthe lodge’s architecture. A pathmeanders along the perimeterof the lodge’s property, and anumber of smaller pathwayslead to more intimate seatingareas. Each is distinctivelytreated with plantings and awater feature. Benches offerguests multiple areas forconversation and reflection.The gardens were designed byMadison Cox Design Inc.National Symphony Orchestraconductor Marvin Hamlischand violinist Marissa Regnipresented a holiday concertat the Edmond J. Safra FamilyLodge in December. It was thethe renown musican’s fifthholiday concert here.ANNUAL REPORT 2011 • 11

SURGERY SPACES RENOVATED TO IMPROVE PROCESS FOR PATIENTS AND VISITORSA new space for theDepartment of PerioperativeMedicine’s family waiting andoutpatient arrival area offersseparate enclaves for privacyand comfort.CRACKING A SMILESurgery is a multi-step process for patients andfor their loved ones, too. Recognition of the stakeholdersand the several stages involved in preparingfor an invasive procedure led to a recentlycompleted renovation of some areas of the ClinicalCenter Department of Perioperative Medicine.The pre-anesthesia clinic now includes three interviewand exam areas, along with a separate waitingarea, which allows for more privacy and a morerelaxed setting.At the clinic, patients scheduledfor surgery review the planned procedure and therisks of anesthesia with staff and have the opportunityto bring up any questions or discuss concerns.On the day of their surgery, outpatients reportto the new waiting area, where loved ones of allsurgical patients can wait to hear from the medicalteam. Closer to the procedure areas and recoveryroom than its predecessor, the new waitingarea features isolated areas where family membersand friends can gather separate from otherpatients’ visitors.An appreciated addition to the new space isa private room for sensitive conversations.A volunteer services representative is presentto answer questions and assist the arriving outpatientsand the waiting family and friends.A bright, new holding area lets the surgicalteam take proper preparation steps—suchas documentation and site marking—efficientlyand privately.Clowns from the Ringling Br os.and Barnum & Bailey Circusvisited Clinical Centerpatients—includingVienna Mariela MartinezFuentes—in March.12 • ANNU AL REPORT 2011

FRESHER, MORESEASONALCELEBRATING PATIENT SIBLINGSThe new “elegant”Clinical Center patientmenu features fresheringredients and newofferings from theNutrition Department.More fresh foods, more variety,redesigned layout.The ClinicalCenter Nutrition Departmentrolled out its revised patientmenu in mid-2010.The new menu replacessome frozen foods with freshversions. For example, freshspinach replaces frozen spinachon the dinner sides menu.TheFall/Winter seasonal menu also offers more variety,adding shrimp, pork chops, beef stew, baked sweetpotatoes, and a variety of new soups, includinga soup of the day.The menu is without addedtrans fat.“The Clinical Center strives to be ahead ofthe curve when it comes to our room serviceprogram,” said Jennifer Widger, Food ServiceSection chief, comparing the new menu to theoptions offered at other hospitals.“We provide a‘build-your-own’ concept for many of our items,such as a salad bar and pasta bar, so patients cancombine whichever ingredients they would like.”The recipes are developed by the department’scertified executive chef, Robert Hedetniemi.Every new menu item is then thoroughlyreviewed by clinical dietitians who determine ifthe item complies with more than 150 diets.Nutrition Department food preparation staff andphone operators receive training on new recipesand participate in a taste test, so they can answerquestions about items. Lee Unangst, dietitianinformaticist and manager of the department’scomplex computer system, ensures ingredients andnutrition information is accurate and correct.With a diverse patient population, the CC mustwork to feed a variety of diets.“Because we serve patients from all over the world,there are, of course, different food preferences,”explained Widger, describing how her groupfound a source of halal-certified meat for aMuslim patient who came to the CC for a lengthystay.“When we get a patient request, we honor it.”Brothers and sisters of Clinical Center patientswere honored during the Third Annual SiblingDay at the Clinical Center on July 13, 2010.“It is truly important that there is a time . . .they can be a proud, contributing memberof their family,” said Dr. Lori Wiener, eventorganizer and coordinator of NCI’s PediatricPsychosocial Support Program.The programis conducted in conjunction with the ClinicalCenter Rehabilitation Medicine DepartmentRecreation Therapy Section and The Children’sInn. Participants visited the Department ofLaboratory Medicine, the Department ofPerioperative Medicine, and a mock scanner in theNational Institute of Mental Health BehavioralHealth Clinic. Chief of the Recreation TherapySection Donna Gregory facilitated therapeuticactivities encouraging the siblings to talk abouttheir experiences with a sick brother or sister andstarting a conversation on what they face and howthey cope with it.In an operating room, siblingslearned how staff sterilize theenvironment and got a chanceto practice surgery in a mockbelly. Nurse Shayna Herbertshowed patient siblings KatalinaKhoury (left) and Kassidy Kochsome of the tools surgeons use.A N N U A L R E P O RT 2 0 1 1 • 1 3

HOSPITAL RECOGNIZES COMMUNITY OF CAREGIVERSWITH DAY OF ACTIVITYDr. Richard Schulz, anationally recognizedexpert in the field ofcaregiver research,was guest speaker.In recognition of the support provided by familyand loved ones to patients participating in clinicalresearch, the Clinical Center celebrated NationalFamily Caregiver Month with Family CaregiverDay on November 1, 2010.Research shows that family caregivers are atincreased risk for health, emotional, financial,and work-related problems. In addition, familycaregivers often find themselves in positions thatmake it difficult to maintain their own health.“Caregivers report a lot of disruption in theirsleep, high levels of physical and emotional fatigue,and high levels of distress that might even suggestthat they need clinical intervention,” said Dr.Margaret Bevans, clinical nurse scientist in Nursingand Patient Care Services.According to Bevans,research in the chronic care setting shows thatindividuals who provide informal care to lovedones exhibit not only an increase in morbidity, butmay also have an increased risk of mortality.The agenda for Family Caregiver Day includeda presentation from guest speaker Dr. RichardSchulz, a nationally recognized expert in the fieldof caregiver research. Schulz is the director of theUniversity Center for Social and Urban Researchat the University of Pittsburgh. His talk—”Reflections on Three Decades of Research onCaregiving”—described some of the psychosocialand general health issues encountered by familycaregivers, along with intervention research andimplications for policy.As a caregiver for her husband, Nancy Bradfield ofHarrisonburg,Va., understands how hard it can be.“For people who are just coming into a situationwhere their loved one has been diagnosed with aserious illness, it can be quite a challenge,” she said.“I think that if you can tell yourself that you needto stay as optimistic as possible, it helps a lot.Andtry to communicate as well as you can with thepatient.”Events included an information fair and expo; aninteractive art project; sessions with mental healthand social work workers; and fitness, yoga, andmassage demonstrations.“We are already caring for a unique population,so we need to think of our caregivers as having todeal with unique challenges.They are managingnot just the clinical needs of their loved ones, butthey also need to understand and interpret theneeds associated with the clinical trial their lovedone is enrolled in.This is an added complexity,”said Bevans.She is currently investigating the effectivenessof problem-solving education in caregiversand patients who are receiving stem celltransplantation.“We are trying to determineif caregivers who are supporting individualsundergoing a stem cell transplant also reportlevels of emotional distress or symptoms thatwill put them at risk for health issues in thefuture,” she said.Ideally, Bevans would like to see caregiversmaximize the resources and education available tothem while at the CC, giving them the knowledgeand resources necessary to stay healthy when theyreturn home.“If you think about the role of the caregiver—thecommitment to their family, their employer, theirown health—one can easily recognize the scope ofthe caregiving experience. It’s much broader thanwhat we see when they are with us,” she said.14 • ANNUAL REPORT 2011

Asyky Maris works a papercutout of a hand to add to the“Collage of Helping Hands”interactive art project offeredby the Rehabilitation MedicineDepartment Recreation TherapySection.TEEN RETREATMembers of The Children’s Inn band—including staff members Alex Florez(left) and Joe Hage—serenadedparticipants in the Fourth Annual TeenRetreat in June 2010. The ClinicalCenter Rehabilitation Medicine Department’sRecreation Therapy Section—in collaboration with The Children’sInn—coordinates the event, whichoffered two days of programs aimedat balancing therapeutic activities withteam-building exercises.ANNUAL REPORT 2011• 15

Advancing Clinical Research PROTOCOLS BY RESEARCH TYPE(ONSITE INTRAMURAL PROTOCOLS, FISCAL YEAR 2010)Total active protocols: 1,443Clinical trials: 638 (44%)Training: 21 (2%)Sample/data analysis: 120 (8%)Screening: 67 (5%)Natural history: 580 (40%)Pharmaco-dynamics/kinetics studies: 17 (1%)Clinical studies are medical research studies (or protocols)in which human volunteers participate. Clinical trialsare studies developing or investigating new treatmentsand medications for diseases and conditions. Naturalhistory studies investigate normal human biology andthe development of a particular disease. Screening studiesdetermine if individuals may be suitable candidates forinclusion in a particular study. Training studies providean opportunity for staff physicians and other health-careprofessionals to follow particular types of patients.Breakdown of clinical trialsTotal clinical trials: 638Phase 0: 9 (1%)Phase I: 198 (31%)Phase I-2: 70 (11%)Phase 2: 307 (49%)Phase 3: 39 (6%)Phase 4 15 (2%)Clinical trials phasesPhase 0: An initial first-in-human study (20-30participants) under an exploratory IND(investigational new drug) for earlyidentification of biologic and molecularmarkers in new clinical agents.There is verylittle agent exposure with no therapeutic ordiagnostic intent.Phase I:Researchers test a new drug or treatmentfor the first time in a small group of people(20–80) to evaluate its safety, determine a safedosage range, and identify side effects.Phase II: The study drug or treatment is given to alarger group of people (100–300) to see if it iseffective and to further evaluate its safety.Phase III: The study drug or treatment is given tolarge groups of people (3,000 or more) toconfirm its effectiveness, monitor side effects,compare it with commonly used treatments,and collect information that will ensuresafe usage.Phase IV: These studies are done after the drugor treatment has been marketed. Researcherscontinue to collect information about theeffect of the drug or treatment in variouspopulations and to determine any side effectsfrom long-term use.16 • ANNUAL REPORT 2011

THE ROAD AHEAD FOR CLINICAL RESEARCH NURSINGClinical research nurses from more than 20 statesand four countries discussed the “Road Ahead”during the Second Annual InternationalAssociation of Clinical Research Nurses (IACRN)Conference co-hosted by Clinical Center Nursingand Patient Care in November 2010.Dr. Christine Grady, acting chief of the CCBioethics Department, delivered the conference’skeynote,“Clinical Research Nursing: EthicalFoundations and Challenges on the Road Ahead.”Grady described some of the central ethical tensionsexperienced by nurses in a clinical researchsetting and encouraged nurses to be active, vocalmembers of the research team.“Each of the diverse nursing roles has its ownabsolute critical function in the conduct of clinicalresearch, and all of us are committed to qualityresearch practices, high ethical standards, regulatorycompliance, and human subjects protection,” shesaid.“In order to accomplish those goals, we needto be familiar with the ethical challenges that weface—the principles, regulations, and other guidancefor the ethical conduct of clinical research.”According to Grady, clinical research nurses orresearch nurse coordinators often find themselvesin a position where they are advocates for threecompeting components of research: the individualas patient, the individual as study participant, andthe research.“All of us, I think, can recognize times when thereis a tension between a data point that needs to betaken care of and a patient who might be upset orasleep,” she said.“We wake them up, we calm themdown, but the tension that we feel in that process isreal.There are struggles between what we believeis important for the comfort and interest of thepatient, and the need to collect and reportaccurate data.”DEFINING CLINICAL RESEARCHNURSINGDiscover a better nursing career for a better world.So said a video played at the beginning of theClinical Research Nursing 2010: Nursing Practiceat America’s Research Hospital pre-conferenceNovember 17, 2010.Clinical Center Nursing and Patient Care Serviceshosted the event, which was held the day beforethe International Association of Clinical ResearchNurses conference.The pre-conference reviewedthe department’s four-year initiative to define thespecialty.“Clinical research nursing encompassesthe care that is required because of the conditionthe patient has and any work that is necessary forthe clinical research study,” said Dr. Clare Hastings,chief nurse officer.“If the person has diabetes, aclinical research nurse takes care of the diabetes.There is also serial sampling, blood draws, andother procedures that are part of the protocol.”The CRN2010 initiative was launched in 2007following a review that encouraged nursing toshare the specialized nature of its practice.A team of nurses worked to define the domain ofpractice through interviews, review ofCC Chief Nursing OfficerDr. Clare Hastings (left)accepted the IACRNDistinguished ClinicalResearch Nurse Awardfrom the association’s pastpresidentMargaret McCabe(center) and current presidentNicole Mullen (right).Acting chief of the CCBioethics DepartmentDr. Christine Grady deliveredthe IACRN conference keynoteon ethical foundations andchallenges of clinical researchnursing.ANNUAL REPORT 2011• 17

A panel of representativesof different clinical researchnursing positions gave theirperspectives on their roles inresearch. Participating were(from left) Leslie Wehrlen,nurse specialist in research;Dirk Darnell, clinical researchnurse; and Carol Levinson,senior clinical researchnurse.clinical research nurse job descriptions, and reviewof relevant of literature.They narrowed their findingsto five dimensions that represent the specialty.“CRN2010 was the basis for our strategic plan,and we feel very good that we accomplished whatwe set out to do,” Hastings said.Clinical Research Nursing 2010 took this definitionto the level of detail and consensus requiredto create a certification process for nurses practicingin clinical research.This nursing specialtyfocuses on the care of research participants. Inaddition to providing and coordinating clinicalcare, clinical research nurses have a central rolein assuring participant safety, ongoing maintenanceof informed consent, integrity of protocolimplementation, accuracy of data collection, datarecording, and follow up.Hastings also explained the role of nurses at theCC and demonstrated the value of the professionin the research process.“If you want precision datacollection and patient care as specified in the protocol,you can’t be understaffed,” she said.Pre-conference attendees, who came from academicinstitutions across the country, heard fromLCDR Dr. Margaret Bevans on the results of arole delineation study—differences between aresearch nurse coordinator and a clinical researchnurse—and the need for further analysis.Representatives from different roles gave theirperspectives on nursing roles in research, andnurses attended round table discussions on innovativeapproaches to a particular challenge inclinical research nursing.The afternoon also heldan opportunity for tours of the Clinical Centerand discussion of research in particular patient caresettings.Bertha Robbins, clinical research nurse coordinator,is one of a small research staff at MiddlesexHospital Cancer Center in Middletown, Conn.She traveled to the Clinical Research Nursing2010 pre-conference to learn from and share withothers in her field.“I think the initiative is a greatidea,” Robbins said.“This is the only way to movethe profession forward.”18 • ANNUAL REPORT 2011

DECKER LECTURE COMBATS MYTHS AROUND HOSPITAL-ACQUIRED INFECTIONSThe seventh in a series honoring NIH leaders inclinical teaching, the 2010 John Laws Decker MemorialLecture in June, highlighted the work of Dr.Tara Palmore, deputy hospital epidemiologist at theClinical Center and staff clinician at the NationalInstitute of Allergy and Infectious Diseases. Palmoreis the recipient of the NIH Fellows Committee’s2009 Distinguished Clinical Teacher Award.Palmore’s lecture,“Hospital Infections: Rumors andReality,” addressed common misconceptions abouthospital-acquired infections, an area of interest ofthe NIH community evidenced by the crowd atLipsett Amphitheater.Hospital-acquired infections—which affect nearly2 million people a year and kill an estimated99,000—come at a serious cost, economically,and socially, Palmore said.“An intangible but extremely important consequenceof hospital infections is a loss of publicconfidence in the health-care system, which allowsthese infections to occur in a place where peoplego to get well,” she said.Palmore refuted the misconception that “hospitalinfections are bound to happen” and explainedways health-care professionals can prevent and treatinfections. Palmore discussed the CC policy ofmandatory flu vaccination for patient-care staff.“The reality is that flu vaccination of health-careworkers saves patient lives,” she said.Palmore discussed strategies to prevent or terminatethe transmission of infection and encouraged lectureattendees to always consider the possibility ofan outbreak until proven otherwise and to avoidviewing single infections as isolated incidentsor coincidences.“Hospital infections should not be accepted as anormal part of patient care,” she said.“We aren’tgoing to get certificates for having clean hands,but preventing infections is really its own reward.”Palmore came to the NIH in 2001 as an infectiousdisease fellow after completing her medical degreeat the University ofVirginia School of Medicineand residency at NewYork-Presbyterian/WeillCornell Medical Center. She joined the NIH staffin 2005 and became deputy hospital epidemiologistin 2007. Palmore directs development, organization,and implementation of the CC infection controlprogram.The annual lecture is presented in memory offormer CC Director Dr. John Laws Decker, whodied in 2000. He served as director of the CCand as NIH associate director for clinical carefrom 1983 until 1990, after which he was namedscientist emeritus.Dr. Tara Palmore presentedthe 2010 John Laws DeckerMemorial Lecture.Doppman imaging lecture presents “The Evolution of PET”Radiology and Imaging Sciences hosted the 10th annual John DoppmanMemorial Lecture for Imaging Sciences on October 27, 2010.Dr. Carolyn Cidis Meltzer,William P.Timmie Professor and Chair ofRadiology, as well as associate dean for research at Emory University School ofMedicine, was the speaker. She is also director of the Emory Center for SystemsImaging.Meltzer spoke on “The Evolution of PET: Images of Progress.”The Doppman lecture is held in honor of the late chief of the CC’sformer Diagnostic Radiology Department.Dr. David Bluemke, directorof CC Radiology and ImagingSciences, with CarolynCidis Meltzer, who presentedthe 10th John DoppmanMemorial Lecture for ImagingSciences.ANNUAL REPORT 2011 • 19

Recovery Act funds go to Clinical Center projectsFunding from the American Recovery and Reinvestment Act is enabling major purchases in support ofinitiatives that will help stimulate advances in science and technology. The projects are:• Instrument to provide automated assessment of the white blood cell differential, identifying thefraction of white cells that are neutrophils, monocytes, lymphocytes, eosinophils, and basophils.• Hardware and software upgrades for the Clinical Research Information System (CRIS), theelectronic patient record application.• Upgrade to existing information technology system to integrate the new perioperative informationsystem and extend the infectious diseases and health-care epidemiology surveillance platform tooutpatients.• New capability for centralized patient scheduling that integrates into the Clinical ResearchInformation System.• Hi-resolution display monitors so clinicians have greater access for review of images from theElectronic Picture Archiving Communications Systems that enable filmless radiology operations.• Portable computers to enhance quality care and patient safety by facilitating documentation at thepoint of care.• Expansion of the perioperative information system, which enables procedures scheduling andnursing/physician/anesthesia documentation. Information will be integrated to the ClinicalResearch Information System.• System to automate the process of nucleic acid extraction from samples, which increases theefficiency of molecular diagnostic services.• Freezers to replace old and outdated equipment for use with clinical blood products, reagents, andclinical specimens.• Freezers to replace equipment used to store cellular therapy products, rare red blood cells, andhuman leukocyte antigen (HLA) specimens for clinical use.• Equipment used during surgeries when excessive blood loss occurs. Such pumps can be life-savingby rapidly infusing large volumes of blood and blood products.• Replacement endoscopes that are used during surgical procedures to visualize the respiratory andgastrointestinal tracts.• Equipment to support ultrasounds, oxygen-dependent patients, and patients in impendingrespiratory failure.• New server that will allow storage of complex data for electronic data-capture projects involvingmovement analysis studies in rehabilitation medicine.• Hardware and software to provide authentication to all clinical and administrative informationsystems following Homeland Security Presidential Directive 12 regulations using the GovernmentSmart Card.• Equipment to automate the process of isolating specific cell types, based on surface antigens usingmonoclonal antibodies.• Equipment to enhance support for the hospital standard for intravenous medication safety infusion.• Software that enables extracting data from the CRIS and ancillary systems to the DataTransformation Initiative System used for financial and activity reporting by protocol.• Hardware and software to enable patient and health-care provider access to patient records andfacilitate communications with the NIH care and research teams.• New PET/CT (positron emission tomography) scanner to strengthen and expand support forclinical research, patient care.• Equipment to improve the quality of peripheral blood and bone marrow smears used inlaboratory tests.• Patient lifts to ensure staff safety and patient-care efficiency.• Support to accelerate efforts to transition to and maintain electronic medical records for patients.• Upgrades for processing servers and Tesla acceleration systems to facilitate more rapid generation ofhigher-quality patient images.20 • ANNUAL REPORT 2011

ASTUTE CLINICIAN EXAMINES GENES’ ROLE IN LIVER AND HEART DISEASEThe 13th annual Astute Clinician Lecture broughta crowd to Masur Auditorium on November 17,2010, with a popular topic—“GenesVersus FastFoods: Eat, Drink & BeWary.”Dr. Helen H. Hobbs delivered the lecture establishedthrough a gift from the late Dr. RobertW. Millerand his wife Haruko.The Astute Clinician Lectureshiphonors a US scientist who has observed an unusualoccurrence and, by investigating it, has openedan important new avenue of research.Hobbs is a Howard Hughes Medical Institute investigator,director of the Eugene McDermott Centerfor Human Growth and Development, and professorof internal medicine and molecular genetics at theUniversity ofTexas Southwestern Medical Center.For the past 10 years she has spearheaded the DallasHeart Study, a large population-based study of DallasCounty.In her lecture—part of the NIH Director’sWednesdayAfternoon Lecture Series—Hobbs presentedthe case study of Morgan Spurlock, the star of thedocumentary “Supersize Me” that chronicled hisexperience with a McDonald’s-only diet. Spurlock’selevated liver function tests and cholesterol levelsafter only 12 days of his experiment is indicativeof the effect such diet has on many Americans,albeit at a slower rate, Hobbs said.The elevated liver function tests are most likely dueto the development of fatty liver disease, which isassociated with both obesity and insulin resistance.However, some diabetics and obese people do nothave fatty liver disease, Hobbs said.“The question that we wanted to address was‘Are there genetic factors that are responsible forindividuals contributing to the propensity to deposittriglyceride in the liver?’” she said.Hobbs’ team also used genetics to examine therelationship between plasma levels of cholesterol andheart disease. Researchers know that high plasmalevels of cholesterol promote atherosclerosis (plaquebuildup in the arteries), Hobbs said. She presentedevidence that low plasma levels of cholesterol, ifmaintained over a lifetime, provide protection fromheart disease.Dr. Helen Hobbs of Universityitof Texas Southwestern MedicalCenter presented the 13thannual Astute Clinician Lecuture.With her is Dr. William Gahl,NHGRI clinical director.MEETING SUPPORTS ADVANCEMENT IN CRITICAL CARE TRIALSClinical Center staff joined other NIH representativesand researchers from around the nation toencourage the best science and exchange ideas onclinical trials in critical care medicine in November2010.Approximately 100 researchers attended the thirdmeeting of the US Critical Illness and InjuryTrialsGroup, which vets study ideas, offers networkingopportunities, and facilitates large, multi-center trials.This year’s meeting at Natcher Conference Centerfocused on neurologic emergencies.Attendees discussedthe key role played by emergency room andICU staff in treating strokes and other neurologicemergencies, when quick response matters most.“Meetings like this improve the efficiency of studies,”said Dr.Anthony Suffredini, associate chief of the CCCritical Care Medicine Department and member ofthe meeting organizing committee.“There was a lotof synergy between different groups in the multidisciplinarycritical care community who might nototherwise have the opportunity to communicate orcollaborate.”A N N U A L R E P O RT 2 0 1 1 • 2 1

SYMPOSIUM PRESENTS CHALLENGES AND TRIUMPHS OFTRANSFUSION MEDICINECC Department of TransfusionMedicine Chief Dr. Harvey Klein(left) presented the 2010 RichardJ. Davey Award to Dr. WalterDzik of Massachusetts GeneralHospital for his dedication toresearch and education in transfusionmedicine.The Clinical Center Department of TransfusionMedicine hosted the 29th annual Immunohematology& Blood Transfusion Symposium, cosponsoredby the American Red Cross, in MasurAuditorium on September 16, 2010.The programprovides practical information about recentdevelopments, current practices, controversies, andlaboratory management issues relative to transfusionmedicine.The Richard J. Davey Award—given annuallyto an individual whose contributions havesignificantly advanced the field of transfusionmedicine—was presented to Dr.Walter Dzik,co-director of the Blood Transfusion Service atMassachusetts General Hospital and associateprofessor of pathology at Harvard Medical School.He was a fellow in transfusion medicine herefrom 1981 to 1983.During the symposium, Dzik presented on cerebralmalaria and cytoadherence. Infected red bloodcells attach to blood vessels by binding proteinpfEMP-1 to the CD-36 antigen. CD-36 is foundon platelets, which bond to endothelium (layer ofcells in blood vessels), and endothelium itself.The clusters of red blood cells, platelets, andendothelium make blood delivery difficult andan be lethal.Complicating the connection, CD-36is also present on monocytes, which swallow redblood cells thereby protecting from dangerousadhesions to endothelium.After a few unsuccessful attempts, Dzik’s groupfound a way to code for CD-36 on monocytesversus platelets to examine expression in relationto cerebral malaria and outpatient malaria.Theyare doing so in a clinical study in Uganda.”Thereare a lot of obstacles in trying to get to the heartof that matter,” Dzik said.“You just have to acceptthat and keep working toward your intent.”Dr. Susan Stramer, executive scientific officer atthe American Red Cross, presented “Plagues inthe Blood Supply? Emerging Infectious DiseaseAgents du Jour” and listed causes of infectiousdisease risk, including failure of donor selection,insensitive tests, mutant/variant organisms, andemerging/reemerging agents. Other presentationsduring the day-long symposium focused on infectiousdiseases, blood and drug evaluation, bloodusage and monitoring, and application of redblood cell molecular testing.physician draws acrowd in LipsettReflecting on the lessons learned andchallenges faced in the field with internationalmedical humanitarian organization DoctorsWithout Borders/Médecins Sans Frontieres(MSF), Dr. Jean-Herve Bradol spoke to apacked Lipsett Auditorium on April 16, 2010.Director of research at the MSF Center forReflection on Humanitarian Action & Knowledge,Bradol has extensive field experiencewith MSF including in refugee camps in Thailandand in Rwanda during the early 1990s.He also served as president of MSF-France foreight years and is a former board member ofMSF-USA. Bradol discussed his experiencewith Burmese refugees in Thailand sufferingfrom advanced malaria. A patient told him thathe had resorted to smuggled drugs from Chinabecause the MSF drugs were not working. Bradol’steam obtained the other pharmaceuticalsand started investigating their safetyand efficacy.“But setting up trials in those environments isnot that easy,” Bradol said. The refugee communitywas not initially receptive to using aChinese drug not registered in their country,and ethical concerns were rampant in conductingresearch with such a patient population.“How can a refugee give consent when thequestion is asked by the very organization thatprovides their basic survival? The person isnot really in a position to say no,” Bradol said.He reported that with advance treatments andpreventive measures such as mosquito nets,malaria is no longer a major public health issuein that area.His lecture coincided with the release of theMSF collection Medical Innovation in HumanitarianSituations: The Work of Médecins SansFrontieres, which illustrates 10 examples of thecomplexities of introducing medical innovationsin the midst of difficult humanitarian crises.22 • ANNUAL REPORT 2011

PHARMACEUTICAL DEVELOPMENT SECTION UPGRADES TONEW, TAILOR-MADE SPACEThe unique and groundbreaking work of theClinical Center calls for clinical trial drugs notalways available from a study sponsor, so we makeour own.The CC Pharmacy Department PharmaceuticalDevelopment Section (PDS) was established in1956 and has operated in several areas over the lasthalf-century. Evolving good manufacturing practices,as mandated by the Food and Drug Administration,presented an opportunity to upgrade thePDS environment and equipment in a new spacecreated especially for the section.PDS formulates and analyzes vaccines and medicationsnot able to be purchased from manufacturers.These products account for one-third of the1,000 separate drugs (including placebos andvarying strengths) that the CC uses in its researchprotocols, said PDS Chief George Grimes, Jr.An example is a topical, sterile gel of resiniferatoxin,which PDS is developing for researchinto its utility as a pain treatment in an upcomingNational Institute of Dental and CraniofacialResearch protocol from Dr. Mike Iadarola, chiefof the NIDCR Integrative Neurobiology andNeuronal Gene Expression Unit, and Dr.AndrewMannes, staff clinician in the CC Department ofPerioperative Medicine.The section also registers and packages all drugsobtained from outside pharmaceutical companiesfor use in CC clinical trials.“We handle all investigationaldrugs,” Grimes said.“In the double-blindstudies in particular, all the drugs look alike, so wehave to be really good about record-keeping andprocedures.”In the new facility, there’s a different room forseemingly every step of their process, allowing forbetter air and overall quality control, Grimes said.Where staffers work with HIV-infected blood inthe Clinical Pharmacokinetic Research Laboratory,for example, negative air flow (pulling more air inthan is pumped out) and the use of a biologicalsafety cabinet decreases the risk of contaminationoutside the confines of the laboratory.Clinical Pharmacokinetic Research Laboratorystaff characterize how drugs are excreted andmetabolized, another function of the PDS.Pharmaceutical DevelopmentSection Chief GeorgeGrimes, Jr., does the honorsat a ribbon-cutting onJanuary 8, 2010. With himare CC Director Dr. John I.Gallin (left) and PharmacyChief Robert DeChristoforo.PDS staff (from left) KumiIshida, Scott Hotaling, andRam Agarwal adjust the newautomatic capsule machinein their section’s updatedarea.ANNUAL REPORT 2011• 23

2010 BENCH-TO-BEDSIDE AWARDSAIDS CATEGORY: PROJECTS FUNDED BY OFFICE OF AIDS RESEARCHThe Bench-to-Bedside (B2B) Program was launched in 1999, and 176 projects totaling about$40 million have been funded to date. The program expanded in 2006 to include extramuralcollaborators with 68 grants supplemented so far. Over the past five cycles, extramural interestin the program has greatly increased; in the current 2011 application cycle, investigators from114 extramural institutions were listed as collaborators or principal investigators on the143 Letters of Intent.PROJECTNew Bioinformatic Approach toDetermine HIV IncidenceRole of Gut-Associated LymphoidTissue in HIV-1 PersistenceMultiplex Microarray Chip-basedDiagnosis of Respiratory Infectionsin HIVINVESTIGATORS INSTITUTE(S)/INSTITUTIONNCI: F. Maldarelli; M. Kearney; W. Shao; NIAID: R. Dewar; Johns Hopkins University,Bloomberg School of Public Health: J. Margolick; Los Angeles Biomedical Research Instituteat Harbor-UCLA Medical Center; (LA BioMed): E. DaarNCI: F. Maldarelli; M. Kearney; University of Pittsburgh: D. McMahon; National Naval MedicalCenter: A. GanesanCC: J. Kovacs; A. Suffredini; P. Murray; NIAID: S. Holland; J. Cuellar-Rodriguez;NCI: J. Gea-Banacloche; R. Lempicki; Washington Hospital Center: M. SmithBEHAVIORAL & SOCIAL SCIENCES CATEGORY: PROJECT FUNDED BY OFFICE OF BEHAVIORAL & SOCIAL SCIENCES RESEARCHAntibody Identification and IVIGTreatment of PANDASNIMH: S. Swedo; Yale University: J. Leckman; Oklahoma University Health Sciences Center:M. CunninghamWOMEN’S HEALTH: PROJECTS FUNDED BY OFFICE OF RESEARCH ON WOMEN’S HEALTHAdrenal Hyperplasia AmongAdolescent Patients WithPolycystic Ovarian SyndromeNICHD: C. Stratakis; SUNY: S. TenMINORITY HEALTH CATEGORY: PROJECTS CO-FUNDED BY NATIONAL CENTER FOR MINORITY HEALTH & HEALTH DISPARITIES AND INSTITUTES/CENTERSControl of XMRV Replication inPBMCs and Prostate CarcinomasIn vitro Fucosylation to AugmentCord Blood Stem Cell EngraftmentBiochemical Mechanisms of theEtiology of Sickle Cell PainNCI: V. Pathak; A. Rein; W. S. Hu; F. Maldarelli; University of California, Davis: R. deVere White;H.J. KungNHLBI: R. Childs; J. Pantin; CC (Transfusion Medicine): D. StroncekNIDDK: A. Schechter; NINR: R. Dionne; CC (Transfusion Medicine): D. Stroncek; W. SmithBeth Israel Medical Center: R. Portenoy; R. CrucianiGENERAL CATEGORY: PROJECTS CO-FUNDED BY NATIONAL CENTER FOR RESEARCH RESOURCES AND INSTITUTES/CENTERSOptical Guidance for ImprovedProstate Cancer SurgeryImaging CXCR4-ExpressingCancer Using 64CuAMDCC (Radiology and Imaging Sciences): B. Wood; M. Dreher; A. Kapoor; NCI: P. Pinto;W. Linehan; Massachusetts General Hospital: U. MahmoodNIAID: J. Farber; I. Weiss; NIBIB: X. Chen; O. Jacobson; NCI: P. Choyke;Georgetown University: C. IsaacsPHARMACOGENOMICS CATEGORY: PROJECT FUNDED BY FOOD & DRUG ADMINISTRATION (FDA)Mechanism of Response toAnti-TNF Therapy in InflammatoryBowel DiseaseNIAID: M. Yao; W. Strober; I. Fuss; University of MD: R. Cross; M. Flasar24 • ANNUAL REPORT 2011

RARE DISEASES CATEGORY: PROJECTS CO-FUNDED BY OFFICE OF RARE DISEASES RESEARCH AND INSTITUTES/CENTERSPROJECTTargeting Antigen-Antibody Responsesin Systemic Capillary Leak SyndromeSympathetic Innervation & MyocardialInjury in Acute Stress CardiomyopathyPreclinical Testing of Targeted Agentsfor Clinical Development in NF1The DICER1-related PleuropulmonaryBlastoma Cancer PredispositionSyndromeBrain Development in Children withWilliams Syndrome and theLIMK1 GeneThe Role of EGFR inEndolymphatic Sac TumorsINVESTIGATORS INSTITUTE(S)/INSTITUTIONNIAID: K. Druey; T. Myers; S. Porcella; NCI: O. Landgren; NIBIB: A. Gorbach;University of Minnesota: A. Dudek; Mayo College of Medicine: P. GreippCC (Radiology and Imaging Sciences): C. Sibley; D. Bluemke; NINDS: D. Goldstein;NHLBI: D. Rosing; Johns Hopkins: I. Wittstein; F. Bengel; J. Mudd; J. LimaNCI: A. Kim; B. Widemann; E. Dombi; Children’s Hospital Medical Center: N. Ratner; J. WuNCI: C. Kratz; B. Alter; P. Rosenberg; National Children’s Medical Center: A. Hill;Children’s Hospital & Clinics of MN: Y. Messinger; K. SchulzNIMH: K. Berman; J. Kleinman; University of Louisville: C. MervisNCI: P. Dennis; Yale University: A. VortmeyerRARE DISEASES DRUG DEVELOPMENT: PROJECTS CO-FUNDED BY THERAPEUTICS FOR RARE AND NEGLECTED DISEASES PROGRAMAND INSTITUTES/CENTERSA Novel Therapy to Treat Acid Lipase-Deficiency by LCAT InhibitionDevelopment of Combination Therapyfor Niemann-Pick Disease, Type CGene Therapy Clinical Trial for LAD-1Using a Foamy Viral VectorBH3 Mimetics for the Treatment ofAutoimmune LymphoproliferativeSyndromePreventing Aortic Dilation in Womenwith Turner SyndromeImmunogenicity and LeishmaniaVaccine Potential of Sandfly Saliva inHumansNHLBI: A. Remaley; K. Vickers; R. Shamburek; Cincinnati Children’s Hospital MedicalCenter - Research Foundation: G. Grabowski; H. DuNICHD: F. Porter; A. Yergey; S. Bianconi; NHGRI: W. Pavan;Washington University: D. OryNCI: D. Hickstein; University of Washington Medical Center: D. Russell; CincinnatiChildren’s Hospital Medical Center: P. MalikCC (Laboratory Medicine): J. Oliveira Filho; T. Fleisher; NIAID: V. Rao; K. Dowdell;NIDDK: D. AppellaNICHD: C. Bondy; V. Bakalov; J. Zhou; NHLBI: A. Arai; D. Rosing; M. Boehm; V. Sachdev;Johns Hopkins University: J. Van Eyk; Q. FuNIAID: J. Valenzuela; S. Kamhawi; Uniformed Services University of the Health Sciences/Walter Reed Army Medical Center: N. Aronson; George Washington University:M. BottazziPROJECT FUNDED BY THE NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENTThe Role of BDNF in Autism SpectrumDisorder and Cognitive FunctionNICHD: J. Han; C. Pierpaoli; NIMH: K. Martinowich; D. Weinberger; C. Golden Williams;S. Swedo; A. Thurm; NCI: L. Tessarollo; Uniformed Services University of the HealthSciences/Walter Reed Army Medical Center: S. Sharp; GlaxoSmithKlinePharamceuticals: B. LuANNUAL REPORT 2011• 25

NEW UNIT PROVIDES UNIQUE SUPPORT FOR CLINICAL RESEARCHFauci said. Simonson applauded NIH staff for theability to “use their imagination, try to anticipateproblems, and create solutions before they happen.”Inpatient healthy volunteers and low-acuitypatients in clinical trials will typically spendextended periods of time on the unit.The facility,designed as a mini-apartment to make the timespent more comfortable, includes one singleroom (with an anteroom), three double inpatientrooms, a common area for dining, a kitchenette,an exercise area, and laundry space.(Above) Dr. H. Clifford Lane,NIAID clinical director, wasamong speakers at theunit’s opening.(Right) Doing the honors ata ribbon-cutting for the newSpecial Clinical Studies Unitwere (from left) Stewart Simonson,former HHS assistantsecretary for public healthemergency preparedness; Dr.(Col. US Army) Mark Kortepeter,deputy director of the InfectiousDiseases Clinical ResearchProgram at the UniformedServices University of theHealth Sciences; CC DirectorDr. John I. Gallin; and NIAIDDirector Dr. Anthony Fauci.A ribbon-cutting for NIAID’s new SpecialClinical Studies Unit at the Clinical Center washeld on April 14, 2010.The new seven-bedunit, which is in the 5NE-S corridor of theHatfield Building, affords state-of-the-artisolation capabilities.“This new unit is another example of theClinical Center’s ability to adapt to emergencysituations,” said CC Director Dr. John I. Gallinat the ceremony.During the event, NIAID Director Dr.AnthonyFauci presented a special award to Stewart Simonson,former HHS assistant secretary for publichealth emergency preparedness, who was instrumentalin the creation and development of theunit.“He promised it would happen, and here it is,”The entire unit is also capable of functioning as anisolation suite of rooms and can be used to housepatients with known or suspected infections withespecially virulent infectious agents. It will beavailable for use by investigators whose patients aresuspected of having a highly contagious condition.When patient isolation is needed, all four patientrooms and their connecting corridor will bekept under negative pressure at a high rate of airexchange and with HEPA-filtered exhaust.Whenisolation is mandated, access to the unit will berestricted to the unit staff with state-of-the-artinfection control procedures in place. Point-ofcarelaboratory testing and telemetry monitoringare additional capabilities of the unit.Staffing the access-protected Special ClinicalStudies Unit requires a new process, too, said AnnMarie Matlock, nurse manager.While new to theCC, all 10 nurses hired to staff the unit came withclinical experience and a professional interest ininfectious diseases. Specific training was developedand implemented to deal with infectious pathogensstaff could potentially encounter despite theexpected rarity of these types of occupationalexposures or exotic infections, Matlock said.26 • ANNUAL REPORT 2011

DC PARTNERSHIP FOR HIV/AIDS PROGRESS SEES ACCELERATEDACTION, OPENS FOURTH CLINICThe DC Partnership for HIV/AIDS Progress,announced in January 2010, has seen substantialacceleration in progress for the four original pillarsof the program, said Dr. Henry Masur, chief of theClinical Center Critical Care Medicine Department.In addition to directing the overall project in collaborationwith Dr. Carl Dieffenbach, director ofthe National Institute of Allergy and InfectiousDiseases (NIAID) Division of AIDS, Masur leadsone of the four pillars—enhanced care.Theothers—surveillance, prevention, and test andtreat—complete the base of the initiative.Theinitial investment in this long-term program, $26.4million over the first two years, supports clinicalresearch to help address the District’s HIV/AIDSepidemic, where roughly 3 percent of the populationis infected with HIV—among the highestHIV/AIDS rates in the nation.The project is acollaboration among several NIH institutes andcenters and the NIH Office of AIDS Research.One of the most exciting programs in the initiativeis the DC Cohort, which will link electronicrecords from the 12 largest HIV providers in DCto a database that can be used for research andfor quality improvement studies.These 12 clinicalpartner sites see 85 to 90 percent of the District’sHIV patients.The collected information will provideimportant data for epidemiologic and clinicalinvestigations.“We think we will have an unparalleledopportunity to look at an urban cohort,”said Masur.The four clinics where NIH specialists are embeddedto improve HIV subspecialty care for theunderinsured—directed by Dr. Dawn Fishbeinand within Masur’s pillar of enhanced care—haveseen approximately 200 patients with HIV andhepatitis C infections.Three initial clinics openedin June 2009 in connection with existing programsat Family & Medical Counseling Service, Inc., inSoutheast Washington; Unity Health Care’s WalkerJones Health Center in Northeast Washington; andWhitman-Walker Clinic in Northwest.The fourthclinic based at Unity’s D.C. General Health Centeropened in the fall of 2010.In each clinic, NIH staff work directly with patientsto provide care and treatment.As the clinics expand,NIH is adding more experts. Dr.Anu Osinusi,an HIV-hepatitis co-infection specialist from theUniversity of Maryland School of Medicine inBaltimore, joined the Clinical Center to workwith patients at the new Unity Health Care’s D.C.General site and at the Unity’s Walker Jones facility.Additionally, Dr. Suad Kapetanovic, a psychiatristwith extensive HIV clinical and research experienceat the University of Southern California, hasbeen recruited by the National Institute of MentalHealth to develop HIV-related mental healthresearch initiatives in connection with the DCPartnership.“This is a chance for NIH to do something goodfor the city and to expand our intramural researchagenda into more areas that will contribute toreducing the impact of HIV/AIDS in urbanAmerica,” said Masur.The clinics serve as study sites for a currently enrollingsafety and tolerability clinical research studyexamining an experimental, orally administereddrug in combination with injectable interferon andribavirin to treat hepatitis C in patients with HIV/AIDS.The oral drug has been proven safe and effectiveto treat parasitic infections, and is currentlybeing studied in research volunteers with hepatitisC mono-infection.The new study will involveas many as 35 research volunteers with HIV andhepatitis C who did not respond to prior standardtreatment regimens.New oral medicines potentially could replaceinjectable interferon-based regimens that areassociated with adverse effects. “The patients areexcited about the opportunities they will have tobe enrolled in clinical trials, especially for hepatitisC, which is so hard to treat,” added Osinusi.In addition to the new treatment study, the sitesare participating in a study that is retrospectivelyexamining progression of liver disease in African-American patients with HIV/AIDS and hepatitis Cto evaluate the theory that this population remainsin early stage liver disease longer than otherpopulations with the same co-infections.“We think wewill have anunparalleledopportunity tolook at anurban cohort.”ANNUAL REPORT 2011• 27

LEARNING ABOUT RESEARCHAND HEALTHY EATINGON THE NATIONAL MALLGet kids fired up about scientific research. Demonstratethat healthy food can be tasty and affordable.Toaccomplish these goals, Clinical Centerstaff joined thousands of children, teachers, parents,and scientists on the National Mall in Washingtonon October 23 and 24, 2010, for the inauguralUSA Science and Engineering Festival. More thanhalf a million people attended the event, wherehundreds of NIH employees staffed booths andanswered questions alongside business leaders andrepresentatives from other government agencies.Nearly 900 kids participated in an activity at theClinical Center’s booth, Pack a Lunch with Punchfor Kids in Research, that demonstrated the scientificresearch process.Selecting a favorite food from a menu of options,children learned to form a hypothesis, collect andanalyze data, and report results.A colorful takeaway—alunch box featuring the CC website—reinforced messages about healthy eating.“This was a unique opportunity to educate thecommunity about our research hospital,” said KelliCarrington of the Office of Communications,Patient Recruitment, and Public Liaison.“It wasexciting to see so many young faces eager to selecttheir favorite food for the demo study.” Results ofthe demonstration are posted on the CC website(clinicalcenter.nih.gov) for further use by teachersand parents educating children about the scientificmethod.Also representing at the USA Science Festival, CCExecutive Chef Robert Hedetniemi headlined acooking demonstration with Pete Thomas fromthe second season of NBC’s “The Biggest Loser.”“Learning how to eat is fundamental,” saidThomas, who lost 185 pounds over nine months.“And contrary to popular belief, healthy eatingcan be both very tasty and economical.”In front of the crowd, Hedetniemi prepared threehealthy meals as part of a daily menu: a pomegranateand fig breakfast parfait, an apple-encrustedautumn lunch salad, and a vegetable pasta dinnerdish.The USA Science and Engineering Festival aimsto invigorate the interest of the nation’s youth inscience, technology, engineering, and math.Britt Ehrhardt, Office of Communications,Patient Recruitmentand Public Liason, looks on as ascience festival attendee spinsthe prize wheel, completingthe Pack a Lunch with Punchscience demonstration.CC executive chef RobertHedetniemi prepared preparedthree healthy meals as part of adaily menu during his demonstrationat the USA Science andEngineering Festival while PeteThomas of “The Biggest Loser”discussed his weight loss withthe crowd.Omar Echegoyén, from the Office of Communications,Patient Recruitment, and Public Liaison,chats with young science enthusiasts at the ClinicalCenter booth at the USA Science and EngineeringFestival.28 • ANNUAL REPORT 2011

RESEARCH DAY EXPOSES DIETITIANS TO CLINICAL RESEARCHThe Clinical Center Nutrition Departmentwelcomed 85 attendees from around the countryto an NIH Research Day on March 18, 2010.National Cancer Institute/CC Nutrition andCancer Prevention Research Practicum participantsand local dietetic interns heard a morning ofpresentations from staff before touring the hospitaland the Metabolic Clinical Research Unit to get aglimpse of the work of clinical research dietitiansAttendees heard a welcome and introduction tothe CC from dietetic internship director LCDRMerel Kozlosky, before learning about the role ofdietitians in research from Nancy Sebring. In anacute care hospital, clinical dietitians spend about80 percent of their time on clinical patient care,with the rest devoted to hospital and departmentsupport. Clinical research dietitians, on the otherhand, Sebring said, split their time between thoseresponsibilities and research support, though thebreakdown varies by staff member.Sebring presented some types of nutrition-focusedresearch.“For example, in one of our studies lookingat obesity we’re interested in patients’ tastepreferences—do certain people taste sweet or sourdifferently than others?” Sebring said.In the “Parade of Protocols “presentations, CCclinical research dietitians spoke on their roles invarious NIH studies. Beth Moylan found it importantto evaluate the existing low iodine diet, whichis used in conjunction with the treatment forthyroid cancer patients, due to food manufacturingchanges and an international patient populationconsuming foods grown in different soil compositions.LCDR Jennifer Graf explained balancingtypes of protein for those with methylmalonicacidemia who need enough protein for normalanabolic function but not too much of particularamino acids they cannot properly break down.LT Rachel Drabot recounted helping a cancerresearch patient who experienced a multitude oftreatment side effects by providing her with liquidnutrition supplements, individualized nutritioncounseling, meal plans, and support.Dr.Amber Courville, metabolic research dietitian,presented the Metabolic Clinical Research Unit,where more than a dozen obesity-related studiesare being carried out, such as one examining howgenes and the environment interact to determinebody weight.The unit continues to grow andseveral more protocols with nutrition componentsare currently under development.Dr.Amy Subar, nutritionist from the NationalCancer Institute, spoke on new methods of dietaryassessment, including using cell phone photos totrack what someone eats. Marnie Dobbin, CCclinical research dietitian, presented an overviewof botanical and “other” dietary supplements andresources available to guide safe supplement use.BTRIS—the Biomedical TranslationalResearch Information System—waslaunched in 2009 and is is available to theNIH intramural community, bringing togetherclinical research data from the CC and otherinstitutes and centers.“BTRIS is designed to bring together clinicalresearch data from all the institutes andcenters to give investigators one place toget all their data and allow other users to asknew questions of the old data,” said Dr. JimCimino, chief of the Clinical Center Laboratoryfor Informatics Development.BTRIS provides clinical investigators withaccess to identifiable data for the subjects ontheir own active protocols, while providing allNIH investigators with access to de-identifieddata across all protocols. The advancedsearch, filtering, and aggregation methodsto create data sets support ongoing studiesand stimulate ideas for new research.Dr. Jim Cimino demonstratedthe sorting capabilities of BTRISto a group of NINDS intramuralresearchers in June 2010ANNUAL REPORT 2011• 29

NURSES PRESENT ON TRIBAL COMMUNITY’S ROLE INRESEARCH DEVELOPMENTPresenting at the 2010 NurseLeaders in Native CareConference in July on theirexperience with communitybasedparticipatory researchwere (from left) DesireeGoodman, director of nursing,Fort Belknap ServiceUnit; Teresa N. Brockie,Clinical Center researchnurse specialist; and KathleenAdams, manager ofpublic health nursing, FortBelknap Community Council.Clinical CenterNursing and PatientCare Servicesand nurse leadersfrom the IndianHealth Service(IHS) organizeda symposium andworkshop on theuse of the principlesof community-basedparticipatoryresearch onthe Fort BelknapIndian Reservationin 2009. In2010 NIH, IHS,and Fort Belknaprepresentatives presentedoutcomesfrom those events.At the 2010 Nurse Leaders in Native CareConference held in DC in July, Kathleen Adams,manager of public health nursing, Fort BelknapTribal Health, and Desiree Goodman, director ofnursing, Fort Belknap Service Unit, presented aposter and led a discussion on “Utilizing CommunityBased Participatory Research Principles as aMechanism for Delivery of EBP in TribalCommunities: Fort Belknap Research Symposiumand Evidence-Based Practice Workshop.”Community-based participatory research is a collaborativeapproach that involves tribal communitiesin knowledge generation, intervention research,and policy change. Evidence-based practiceis a problem-solving approach to the delivery ofhealth care that integrates the best evidence fromresearch with a clinician’s expertise and a patient’sor a community’s preferences and values.The research symposium informed practitionersof significant research findings related to community–identifiedhealth topics of concern (communityand family violence, methamphetamineabuse, mental health, and suicide).The interactiveworkshop facilitated and encouraged the implementationof evidence into practice.The presentation at the July conference providedthe process of collaboration—from initiation tothe culmination of the research symposium andworkshop—using a community-based participatoryresearch model for Native American communityengagement.Through continued collaboration with the CC,Fort Belknap nursing is using the process to developa project focused on adolescent alcohol use,with an implementation date of mid-2011.MOVEMENT ANALYSIS LAB STEPS INTO RENOVATED SPACEWITH LATEST EQUIPMENTMore tools make for better research in the ClinicalMovement Analysis Lab in the Clinical CenterRehabilitation Medicine Department Functional& Applied Biomechanics Section. Recentlyrenovated space brings the latest in motioncapture and analysis equipment to the studyof how patient populations move.The lab usesa combination of tools—cameras, electrodes,force plates, and a new body weight supportsystem—to give a comprehensive view of howpatients with debilitating disorders such as cerebralpalsy and osteogenesis imperfecta move.While thefocus is on walking, any type of movement in anypart of the body can be measured.“Combiningall those data gives a full quantitative analysis,” saidLindsey Bellini, a section engineer.The goal is todevelop new strategies to improve movement andto test those strategies already in place, said ChrisStanley, senior research engineer.30 • ANNUAL REPORT 2010

The primary piece of the puzzle involves ten newcameras that measure motion—replacing sevenolder cameras—by recording the changing positionsof reflective markers on specific locationsof the patient’s body.A bone model created fromthe reflective markers calculates joint angles, forexample how much the knee bends when walking.The new motion-capture system features real-timecapability, where the software processes the motionas it occurs, rather than after the motion is completed.Thisallows for more advanced studies andlets researchers check that the capture technologyis set correctly and adjust if necessary.Tiny, wirelesselectromyography electrodes are time-synchronizedwith the system and measure muscle activity, suchas when they fire to propel the person.“Plus it’s really cool to show people,‘this is whatyou’re doing right now,’” Bellini said of the technology,which is also used in sports performanceanalysis and motion picture technology.A color pattern on the floor camouflages platesthat measure three dimensional forces and momentsin each patient’s step.With a lot of pediatricvisitors, the colors are also “just more fun for thekids,” Stanley said.A bigger, better treadmill also holds force plates.The treadmill is split, right and left, to measure andcompare forces on each side.The treadmill willbe used with a new virtual reality system that willbe tested first in patients with Parkinson’s diseaseor traumatic brain injury, the engineers said.Thistype of system can ‘trick’ the person to step overobstacles or navigate through a narrow hallwayor busy store, to more realistically assess how theyfunction in everyday life.The last piece to be installed was a body weightsupport system with a track extended over theforce plates and treadmill.The patient wears a harnessthat is connected to the system, allowing theteam to provide support to enable weak or heavypatients to practice walking when they would notbe able to on their own.Additionally, the supportsystem can help patients safely practice more difficulttasks, such as running or deep squats, withouta fear of falling.The support is dynamic, that isthe same tension isheld through theentire exercise, bothwhen pulling awayand when movingcloser through thenatural gait pattern.“This allows usto start rehabilitationsooner andaccelerate peoplemore quickly.Whenthey’re not supportingtheir entirebody weight, theycan challenge themselves,”said Bellini.Data from all thelab’s tools arecombined to forma more completepicture for bothpatients with motordisabilities andhealthy volunteers.The lab measuresthe effects of interventions—everything fromsurgery to medications, a brace to an exerciseregime—to see if the patient makes and retainsprogress. For example, the movement of a youngchild with a brain injury would be captured andanalyzed before, during, and after completing anexercise program on the elliptical machine to seeif greater practice of making reciprocal arm andleg movements would translate to faster and betterwalking.The renovations were funded by the phenotypingcore of the Center for Neuroscience and RegenerativeMedicine. Ongoing research involves thecategorization and study of pathogenesis in traumaticbrain injuries.The Clinical MovementAnalysis Lab captures thegaits of patients with markersand cameras and displaysthe movement in real-time ona screen in the room.A N N U A L R E P O RT 2 0 1 0 • 3 1

RESEARCH | SPOTL IGHTSFirst full genome sequencecompleted on NIH patientThe first NIH patient to have his whole genomesequenced calls the experience “fabulous” and“eye-opening.”Rick Del Sontro was first to have researcherscomplete a detailed description of the order of thechemical building blocks, or bases, in his DNA.As part of the National Human Genome ResearchInstitute’s ClinSeq study, this milestone is anadvance toward personalized medicine and a betterunderstanding of how patients may react to theirgenetic information.“Ultimately what personal genomics is all aboutis finding out what your risks are and modifyingyour behavior accordingly to maximize stayinghealthy,” NIH Director Dr. Francis S. Collins toldscience reporters in May 2010.The ClinSeq study is a trans-NIH effort tounderstand the genetic roots of disease susceptibilityand the challenges of using genome (the entireset of genetic instructions found in a cell) sequencingtools in a clinical research setting. It is also thefirst study to return individual genetic sequencingresults to research subjects from a large-scalesequencing effort. Coronary heart disease is a goodplace to start because of its high association withgenetic risk factors and the numerous interventionsavailable, reported the research team.While most ClinSeq participants were initiallysequenced for about 300 genes known or suspectedto be associated with heart disease, Del Sontrowas the first chosen for whole genome sequencing.In this process, a person’s three billion basepairs are sequenced to identify the million or sovariants that make everyone unique and hopefullylink some of those to risk of disease. Patients wantto know,“What’s wrong with me? What caused it?What can we do?” said ClinSeq principal investigatorDr. Leslie Biesecker, chief of the NHGRIGenetic Disease Research Branch.“We want touse these genomic technologies to answer thoseembarrassingly simple, but difficult, questions.”Del Sontro enrolled through a referral fromthe NIH Heart Center at Suburban Hospitalin Bethesda, Md.With a family history of heartproblems, he forced himself on a cardiologist,even though he appeared in good health with anIronman triathlon to his record. His doctors found“off-the-charts calcification,” of his coronaryarteries, Del Sontro said, and, after treatment,recommended him to the ClinSeq study forfurther investigation of an underlying cause.Launched in 2007, the research protocol invitesparticipants to the Clinical Center for a half-dayclinical work-up that includes visits to phlebotomyand the EKG heart station.A partner in the study,the National Heart, Lung, and Blood Institute,performs an echocardiogram and a computerizedaxial tomography, or CAT, scan of the heart oneach ClinSeq patient volunteer.“We get a snapshot of the current state of that person’sheart health,” Biesecker said.“We can use thatas the starting point, but only as the starting point,to begin to dissect their long-term risk of havingheart disease.”The blood participants donate is screened formarkers like cholesterol and glucose levels, andsome is sent to the NIH Intramural SequencingCenter where the 300 candidate genes or, inDel Sontro’s case, the whole genome is sequenced.He was selected for the more comprehensive sequencingbecause of the unusual presentationof plaque buildup in his arteries but no historyof high cholesterol, said genetic counselor andClinSeq researcher Flavia Facio. Del Sontroshares this unique health history with generationsof his family and his seven brothers and sisters.Many of them have joined the ClinSeq study.While the initial analysis of Del Sontro’s genomehas not yet revealed the genetic mutation thatcauses his hereditary heart disease, it did showthat he has inherited a condition called hereditaryneuropathy with liability to pressure palsies, whichcauses numbness in his extremities.Though there is no cure, he said he is glad to havean explanation for the trait. Such knowledge couldbe comforting after symptoms have arisen, but it32 • ANNUAL REPORT 2011

is still unclear if patients want to know about theirodds of future disease.Another goal of the Clin-Seq study is to assess how patients feel aboutgenome analysis, which might reveal risk for seriousconditions.“We want to know what patients want; whatpatients think; what they’ll do with the data,”Facio said.She discusses with study participants the possibleoutcomes and what results they would like to benotified of. Her anecdotal experience is that mostwant to know what their tests and gene analysisreports, but Facio is careful to note that her studypopulation is self-selected and not generalizable.She reports that another patient has been selectedfor whole genome sequencing and that others areundergoing exome sequencing (just the portionsof genes that code for proteins, thought to containmost mutations that have a major effect on thecause or predisposition to diseases).“We are intrigued about insights we are gainingfrom the study so far,” Biesecker said.“I think theresearch will be driven by collaboration and whatwe find in the sequencing.”Researchers link gene mutationsto stutteringA trans-NIH study has identified three genesresponsible for stuttering in its patient sample, adiscovery that opens the door to new potentialtreatments for the speech disorder.Led by the National Institute on Deafness andOther Communication Disorders with ClinicalCenter and National Human Genome ResearchInstitute contributors, the study found that stutteringmay be the result of a glitch in the process bywhich cellular components in key regions of thebrain are broken down and recycled.“For hundreds of years, the cause of stuttering hasremained a mystery for researchers and practitionersalike,” said Dr. James F. Battey, Jr., NIDCDdirector.“This is the first study to pinpoint specificgene mutations as the potential cause of stuttering,a disorder that affects three million Americans, andby doing so, could dramatically expand our optionsfor treatment.”Stuttering is a speech disorder in which a personrepeats or prolongs sounds, syllables, or words, disruptingthe normal flow of speech.The conditiontends to run in families, and researchers have longsuspected a genetic component.The NIDCD study grew from previous researchby Dr. Dennis Drayna, a geneticist with the institute,which indicated a place on chromosome 12that was likely to harbor a gene variant that causedstuttering in a group of families from Pakistan.Drayna and his team then refined the location ofinterest on chromosome 12 and identified mutationsin a gene known as GNPTAB, which helpsencode an enzyme that assists in breaking downand recycling cellular components, a process thattakes place inside a cell structure called the lysosome.GNPTAB encodes its enzyme with the help ofanother gene called GNPTG. In addition, a secondenzyme, called NAGPA, acts at the next step in thisprocess and together, these enzymes make up thesignaling mechanism that cells use to steer a varietyof enzymes to the lysosome to do their work.Because of the close relationship among the threegenes in this process, the GNPTG and NAGPAgenes were the next logical place for the researchersto look for possible mutations in people whostutter. Indeed, when they examined these twogenes, they found mutations in individuals whostutter, but not in control groups.The new study involved patients from Pakistan, theUnited States, and England. Dr. Penelope Friedmanof the CC Internal Medicine Consult Serviceand Dr. Donna Krasnewich, assistant clinicaldirector of the NHGRI, went through a medicalhistory and physical examination with each patientseen in the CC to investigate if stuttering occursin tandem with other abnormalities classicallyassociated with severe mutations in these genes.They did not find evidence of such symptoms inthe individuals who stutter.Their initial work is afundamental step in identifying where to look in a“We want to knowwhat patientswant; whatpatients think;what they’ll dowith the data.”ANNUAL REPORT 2011• 33

RESEARCH | SPOTL IGHTSpatient’s DNA and in maintaining the validity ofthe research, Friedman said.The findings open new doors into possible treatmentsfor stuttering.“Stuttering has been thoughtof as a behavioral problem,” Friedman said. Currenttherapies have focused reducing anxiety andregulating breathing and rate of speech. Draynais interested in bringing the study and treatmentof this condition into the world of medicine.An exciting future possibility may be offering enzymereplacement therapy as a potential treatment,as is used for some lysosomal storage disorders.The researchers estimate that roughly 9 percentof people who stutter possess mutations in one ofthe three genes—a lot for such a complex disorder,Friedman said.Among the next steps, Drayna andhis team are conducting a worldwide epidemiologicalstudy to better determine the percentage ofpeople who carry one or more of these mutations.They are also conducting biochemical studies todetermine specifically how the mutations affectthe enzymes.A long-term goal is to use thesefindings to determine how this metabolic defectaffects structures within the brain that are essentialfor fluent speech.In addition to the NIH partners, researchers atthe University of Punjab, Lahore, Pakistan andthe Hollins Communications Research Institute,Roanoke,Va., contributed to this work.Team tackles a debilitating bone disorderBig things come in small packages. Just ask ErinJones.The 14-year-old from the state of Washingtonhad a pea-sized tumor to thank for two brokenfemurs, among multiple other bone fractures.Jones suffered from tumor-induced osteomalacia,a disorder caused by a benign tumor that producesthe hormone FGF23, which affects the metabolismof phosphorus and vitamin D and ultimatelybone strength.A small tumor resting on her tibiawas removed by an NIH team in August 2010, andJones is on her way to a full recovery.Almost asimpressive as the condition is the fact that doctorswere able to find the tumor.“This was the most challenging and thereforemost satisfying case of this disorder we’ve seen,”said Dr. Michael T. Collins, head of the SkeletalClinical Studies Section of the National Instituteof Dental and Craniofacial Research.Jones first came to the Clinical Center in mid­2010. She had broken one leg at age 11 in a simplebike accident. Her physicians sensed there wassomething more complex going on, since heraccident wouldn’t usually cause such an injury.A few months later, her dog jumped into her lapand the chair she was sitting in collapsed. Jonesbroke her other leg.“I got out of one cast, got the flu, then got intoanother cast,” she said, remembering that difficultyear. In addition to the big breaks, Jones had adozen small fractures through her body, from herribs to her feet.Doctors suspected an underlying skeletal disorder,and when her blood phosphorus level came backlow, they thought of tumor-induced osteomalacia.The disorder is very rare—there are fewer than200 cases in the medical literature, Collins said—and even more uncommon in children. Complicatingthe search for a cure for Jones was thenature of the tumors.They are typically very smalland can appear anywhere from head to toe, in softtissue or bone.Her physicians in Seattle did a positron emissiontomography (PET) scan and an octreoscan, whichlooks for tumors, but couldn’t find anything.Thesetests are very sensitive, and in a patient like Joneswith multiple fractures they can “light up likea Christmas tree,” Collins said. Deciding whichmarks on the scan could be the culprit is the difficultpart.While these tumors are always hard to find, Jones’swas proving to be a particularly difficult one. Still,Collins agreed to try to help her. His team didmore scans when Jones came to the NIH, andthrough the process of elimination—ruling outsymmetrical marks and corroborating themarks with CT and MRI—narrowed the34 • ANNUAL REPORT 2011

possible trouble spots to only a few. Dr. ClaraChen, deputy chief of the nuclear medicinesection in Radiology and Imaging Sciences,was instrumental in deciphering which markshad potential and which were misleading,Collins said.With an idea of where the tumor may be, next toJones’ right tibia, Dr. Richard Chang, chief of theendocrine and venous services section, threadeda catheter down a vein in Jones’ leg and tookblood samples at different points to test presenceof FGF23.The numbers spiked around the tumor.Jones was at her grandmother’s house whenCollins called with the news.When she heardthey’d found the tumor, she gave her grandmothera thumbs up.“She started screaming, she was sohappy,” Jones remembered.Dr. Felasfa Wodajo, medical director of InovaHealth System’s Musculoskeletal Tumor Programand a consultant to the National Cancer Institute,removed the tumor in August. Recurrence is rare,especially when a large margin of surroundingtissue is removed, as was done with Jones.She is back in Washington, returning to life asa healthy teen.“I’m back on my swim team,which I really love,” she said.“I can walk in thehall without being worried about knocking intosomething.”The end result wasn’t due to fancy science, Collinssaid, just the meticulous, rigorous teamwork thatoccurs at the CC. “How often in medicine doyou get a chance to really cure someone? Thatwas fantastic.”Study could improve care forrare immune diseaseNIH investigators have observed that the survivalrate of people with a rare immunodeficiencydisease called chronic granulomatous disease(CGD) is greatly improved when even very lowlevels of microbe-killing molecules are present.Because production of these molecules, made by anenzyme called NADPH oxidase, can be predictedfrom genetic analysis, a patient’s risk for severeCGD could be assessed very early in life, allowingfor more personalized treatment, say the researchers.The study was conducted at the Clinical Centerand led by researchers from the National Instituteof Allergy and Infectious Diseases and their associatedlabs at SAIC-Frederick Inc.The study is availableonline in the New England Journal of Medicine.“Advances in treatment of CGD have made itpossible for people with this once-fatal disease ofearly childhood to survive into adulthood; however,the disease remains difficult to manage,” saidNIAID Director Dr.Anthony S. Fauci.“Having amarker to help predict disease prognosis will enablephysicians to recommend treatment optionsthat are more tailored to the needs of individualpatients.”People with CGD have increased susceptibilityto infections caused by certain bacteria and fungi.They can have abscesses in the lungs, liver, spleen,bones, or skin.Those with severe disease also canhave tissue masses, called granulomas, that can obstructthe bowel or urinary tract. CGD affects anestimated 1,200 people in the United States andapproximately 25,000 people worldwide.The disease is caused by inherited mutations inany one of five different genes required by immunecells to make the NADPH oxidase enzyme,which in turn makes superoxide, an oxygenderivedmolecule that immune cells use to destroyharmful bacteria and fungi.All CGD patients haveimpaired superoxide production, but some makea little superoxide, while others make none.Theresearch team found that the level of superoxideproduction was linked to the type of mutation inthe NADPH oxidase gene, and that the more superoxidea patient with CGD can make, the betterthe life expectancy.Until now, the severity of CGD has been linkedonly to how people inherit the NADPH oxidasegene mutation. If people inherit the mutation asan autosomal recessive trait, meaning that twocopies of the abnormal gene, one from each parent,are present, the disease has generally been lesssevere than in those who inherit the mutation asANNUAL REPORT 2011• 35

RESEARCH | SPOTL IGHTSan X-linked trait, meaning that the abnormal geneis located on the female sex chromosome.The majorityof people with CGD inherit the mutationas an X-linked trait.For their study, the NIH team tested the level ofsuperoxide production by immune cells isolatedfrom blood samples taken from 287 people withCGD, aged 1 to 64 years old, compared withsuperoxide production in healthy people.Some tests dated back to 1993, though patientsand families affected by CGD have come tothe CC for treatment since the 1970s.The NIH researchers used methods that coulddetect even trace amounts of superoxide, andgrouped people with CGD based on the amountof superoxide made by the immune cells.Thepatients who produced the highest levels of superoxidehad the highest survival rates, whereas thosewho produced the lowest levels of superoxide hadthe lowest survival rates.“By precisely measuring superoxide production,we observed that even tiny residual amounts, atlevels below what doctors paid attention to in thepast, had a significant impact on patient survival,”said CC Director Dr. John I Gallin, chief ofthe Pathophysiology Section of the NIAIDLaboratory of Host Defenses, and senior authoron the paper.Treatment of CGD consists of lifelong antibioticsand antifungal medications. Some people alsoreceive injections with interferon-gamma, aprotein that can stimulate the immune cells tofight infections. For people with the most severeforms of CGD, bone marrow transplantation isa treatment option, but it carries potentialcomplications that can make patients andtheir families reluctant to elect this therapy.Based on the research team’s observations, doctorsshould be able to use DNA gene-typing resultsto help identify those patients who are candidatesfor more aggressive treatments, including possiblebone marrow transplantation. In addition,therapies designed to promote NADPHoxidase function might reduce CGD severity.“This study is a great example of the specialstrengths of the Clinical Center,” commentedGallin.“We have worked for over three decadeswith patients with CGD, which at one time wasalmost entirely fatal, and have seen vast improvementsin care and treatment.This work now givesus another tool to help individuals fightthis disease.”Additional support for this research was providedby the National Institute of Diabetes andDigestive and Kidney Diseases and theNational Cancer Institute.Finding the new ‘normal’ after allogeneicstem cell transplantationAs any survivor knows, life doesn’t snap back tothe way it was as soon as one hears that coveted“r” word—remission. Nurse researchers at theClinical Center are leading a study to examinefunction, adjustment, quality of life, and symptoms(FAQS) in long-term survivors who have undergonean allogeneic (from a donor) hematopoietic(blood) stem cell transplant (HSCT).Dr. Margaret Bevans and Dr. Sandra Mitchellof Nursing and Patient Care Services and theirmulti-institute study team collect survey data oncea year from participants to characterize the patternof recovery after this intense treatment regimen.Understanding the factors that influence variationin these recovery patterns can help patients knowwhat to expect over the long term and helpclinicians improve services to aid in patients’recovery.“Together with other intramuralresearchers conducting survivorship studies hereon campus, we are contributing to the evidencebase to guide assessment and tailor interventionsin transplant survivors,” Mitchell said.Mitchell and Bevans began their work in 2005,noting gaps in the understanding of the recoveryexperience for several specific groups of transplantsurvivors.As the researchers noted in theirsummary of the study, most previous research hadbeen cross-sectional (giving a snapshot rather thana timline) and had sampled a small number of survivorswith limited diversity.” In the FAQS study,Bevans and Mitchell are examining the extent to36 • ANNUAL REPORT 2011

which a patient’s condition improves, remains thesame, or deteriorates with the passage of time afterHSCT in a large sample of transplant survivorswith clinical and demographic diversity.The NationalHeart, Lung, and Blood Institute performedits first allogeneic HSCT in 1993.Mitchell and Bevans’ FAQS study proceeds intandem with other intramural NIH researchexamining late effects of this intense, often curativetreatment for cancer or a serious bone marrowdisorder.These late effects may include chronicgraft-versus-host disease, osteoporosis, endocrinecomplications, and secondary cancers.“All typical problems seen in cancer survivorsare multiplied after allogeneic HSCT.Thereforethe treatment presents a unique opportunity forresearchers to develop strategies to address late effectsof cancer therapy,” said Dr. Steven Z. Pavletic,head of the Graft-Versus-Host and AutoimmunityUnit in the National Cancer Institute ExperimentalTransplantation and Immunology Branch.As nurse scientists, Bevans and Mitchell are particularlyinterested in the impact these late effectsmay have on how patients feel and function asthey resume usual activities and roles in their dailylives.In the early period of recovery after an allogeneicHSCT, patients and families are often focused onaspects of physical recovery from an aggressivetreatment regimen.As they proceed into the survivorshipphase, other dimensions of well-being includingmood, relationships, and symptoms such asfatigue and impaired sleep problems come to theforefront.The opportunity to complete the studyquestionnaires may help to validate the importanceof these issues, and “may empower survivors to betheir own advocates and raise such concerns withthe doctors, nurses, and social workers on theirtransplant team,” Bevans said.Study results to date suggest that a numberof these dimensions are affected in transplantsurvivors. For example, the team has found thatapproximately 45 percent of study participantshad insomnia, and that those with more physicaland psychological symptom distress reported moreproblems with sleep. Survivors experiencing difficultieswith psychosocial adjustment reported thegreatest concerns with immediate and extendedfamily issues, sexual relationships, and emotionaldistress. Ultimately, Bevans and Mitchell believethat a better understanding of the factors associatedwith variability in recovery can be applied todevelop ways to help patients return to a fulfillingand productive life.“The FAQS study is making major progress inthis direction, but it only addresses the first step—describing the scope of the problem.The bignext challenge is to decide what to do about theproblem,” Pavletic said.“Survivors face a numberof challenges affecting their health and well-being.Much work remains to be done in this arena, andthe NIH can be a major contributor.”Endometriosis survey data gives insight onco-occurring disease, incites researchA study in Fertility and Sterility co-authored byNIH clinician-scientists reported new findings onendometriosis.The paper,“Cancers, infections, andendocrine diseases in women with endometriosis,”has ramifications for care of this patient populationand the advancement of related research,said co-author Dr. Ninet Sinaii of the Biostatisticsand Clinical Epidemiology Service in theClinical Center Office of the Deputy Directorfor Clinical Care.Sinaii began analysis of an Endometriosis Associationsurvey during her doctorate work with theNational Institute of Child Health and HumanDevelopment and continued her series of paperswhen she transferred to the Clinical Center in2006.The 1998 survey covered an array of topicsto capture the broad scope of living with endometriosis,a condition where tissue that usuallygrows inside the uterus shows up elsewhere likethe surface of organs in the pelvis or abdomen.Scientists believe the number of women livingwith endometriosis—said to be between 10 to15 percent of reproductive-age females—may beunderestimated, Sinaii said.ANNUAL REPORT 2011• 37

In addition to the symptoms of long-lastingchronic pain and high rates of infertility directlyattributed to endometriosis, sufferers also have todeal with commonly co-occurring afflictions, theEndometriosis Association survey showed.“Overall, 2,859 (66.0%) women self-reportingsurgical diagnosis of endometriosis also reportedphysician diagnosis of at least one other condition,”the authors of the Fertility and Sterility paperwrote. Most common among responders wereinfectious diseases—recurrent upper respiratoryinfections and recurrent vaginal infections—butmelanoma and ovarian cancers were also noted as“more common in the study population than insimilarly aged women in the general population.”“It’s kind of like a chicken-and-the-eggsituation,” Sinaii said.“While we believe thatwomen with endometriosis may have analtered immune system, we don’t know ifa compromised immune system causesendometriosis or if endometriosis causes acompromised immune system.”The survey results will inform physicians andpatients of possible coexisting conditions afterdiagnosis of endometriosis, Sinaii said.Thefindings may also stimulate further studiesinto the experience of the disease.“This survey data related to other clinical observationsis what helps shape translational research,”said Dr. Pamela Stratton, chief of the GynecologyConsult Service in the NICHD Program inReproductive and Adult Endocrinology andsecond author on the Fertility and Sterility paper.While there is no cure for endometriosis, researchinto better treatments and strategies to preventreoccurrence of symptoms and disease is strong.Stratton is examining the after effects of endometriosis,such as chronic fatigue and heightenedsensitivity to pain, and exploring promising recentresearch involving endometrial stem cells for itspossible link to the central nervous system.38 • ANNUAL REPORT 2011

Training the Next GenerationTRAINING TODAY’S INVESTIGATORS TO FIND TOMORROW’S CURESThe Clinical Center continues to be a primaryresource for training in clinical research, and thedemand for such training has never been higher.The Office of Clinical Research Training andMedical Education develops, administers, andevaluates clinical research training initiatives fornearly every level of career development. Witha summer internship program for high school,college and graduate students, a year-long clinicaland translational research enrichment program formedical and dental students, and even a sabbaticalprogram for experienced researchers, the ClinicalCenter has something for everyone. The CCalso manages a curriculum of three courses inclinical research and graduate medical educationopportunities for clinical fellows.CURRICULUM IN CLINICAL RESEARCHThanks to the latest technology, the CC is ableto broadcast its popular courses, Introduction to thePrinciples and Practice of Clinical Research (IPPCR),Principles of Clinical Pharmacology (PCP), and Ethicaland Regulatory Aspects of Clinical Research, to remotesites domestically and around the world.Thirty-two remote sites with more than 1,100 studentsparticipated in the 2010-11 IPPCR course,including ten international locations such as theAsan Medical Center Clinical Research Centerin Seoul, Korea, and the Walter Sisulu Universityin Eastern Cape Province, South Africa. The CCmakes content available for students using livestream and archived content on the web for thesites without a live broadcast.A record number (1,563) of students enrolled inIPPCR in 2010-11, demonstrating the strong andsustained interest in the subject matter and thepositive reputation of the course. And the wordkeeps spreading. In May 2010, course facultyincluding CC Director Dr. John I. Gallin, conducteda five-day version of the IPPCR coursein-person at the University of Ibadan in Nigeria.Local faculty then continued to work withstudents on the full syllabus.Designed to meet the needs of researchers whohave an interest in the clinical pharmacologicaspects of contemporary drug development andutilization, the Principles of Pharmacology coursehas entered its twelfth year. The course has alsoreached students far away from NIH’s Bethesdacampus. Twenty-three remote sites, includingseven international, and a record 1,200 studentsparticipated in the 2010-11 course.Even the newest course, Ethical and RegulatoryAspects of Clinical Research, saw growth for the2010-11 year. More than 475 students enrolledat both NIH and at 12 remotes sites, includingsix international, which represents a 40% increasefrom 2009.Student participationfor 2010-11IPPCR and PCPANNU AL REPORT 2011 • 39

GRADUATE MEDICAL EDUCATION BROADENSThe Clinical Center, as the Accreditation Councilfor Graduate Medical Education (ACGME)accredited sponsor of graduate medical educationat NIH, made strides to expand the scopeof Graduate Medical Education (GME) trainingoffered to residents and clinical fellows at theNIH. In 2010, the NINDS-based NeurologicalSurgery program officially received accreditationfrom the ACGME, bringing the NIH’s total to 18accredited programs. The Neurological Surgeryprogram represents the first ACGME accreditedsurgical specialty program at the NIH andis the first collaborative training partnership tobe established between the NIH Clinical Centerand the University ofVirginia Medical Center.This seven-year training program, which providesclinical exposure to a large spectrum of patientswith diseases of the brain and spinal cord at bothinstitutions and in-depth exposure to translationalresearch at the NIH, allows trainees to developthe skills necessary to become highly competent,board-certified academic neurosurgeons.Expansion of GME programs furthers the ClinicalCenter’s mission to educate the next generationof clinician-scientists. With more GME programsavailable at the NIH in more specialty fields,researchers are better able to address the broaderneeds of patients.MEDICAL AND DENTAL STUDENTS SEEKOPPORTUNITIES IN RESEARCHThe Clinical Research Training Program (CRTP)has always been a popular program at the NIH.The level of enthusiasm has reached new heightsthis year. Established in 1997, the program offersunique opportunities for medical and dentalstudents to add one year of school to learnthe principles of and to perform clinical andtranslational research at the NIH. The numberof students who apply for the CRTP has grownsteadily over the last seven years, and the CCreceived a record number of applications for the2010-2011 class. The growth in applications tothe CRTP is depicted in the graph below.Expansion to 30 students a yearThis public-private partnershipis supported by the NIHand the Foundation for theNational Institutes of Healththrough a generous grantfrom Pfizer Inc.160140120100806040200Applications1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 201040 • ANNUAL REPORT 2011

FELLOWS PROGRAM ATTRACTS NEW TALENTNew clinical fellows from medical institutionsacross the country mingled at a reception inJuly 2010 with leaders from the different NIHinstitutes and centers. National Institute of MentalHealth Intramural Research Program ScientificDirector Dr. Richard Nakamura (left) and ClinicalDirector Dr. Maryland Pao (right) welcomed theirinstitute’s fellows: (from left) Patricia Bauza fromthe Mayo Clinic, Rishi Kakar from GeorgetownUniversity School of Medicine, and Jose Franco-Chavez from the University of Puerto RicoSchool of Medicine.CTSA VISITORS SEE LATEST FROM THE CLINICAL CENTERThe Clinical Movement Analysis Lab in theRehabilitation Medicine Department Functional& Applied Biomechanics Section was one stop fora group of visiting fellows from the Clinical andTranslational Science Award (CTSA) consortiumon April 7, 2010.The CTSA program—fundedby the NIH National Center for ResearchResources—creates academic homes for clinicaland translational science at research institutionsacross the country.In the Washington, DC, area for the 2010 Clinicaland Translational Research and EducationMeeting, sponsored by the Association for ClinicalResearch Training and the Society for Clinical andTranslational Science, about 75 CTSA representativesfrom academia around the country—suchas Morehouse School of Medicine,WashingtonUniversity in St. Louis, and Weill Cornell MedicalCollege—toured the CCafter an overview of thehospital from CC DeputyDirector for EducationalAffairs and StrategicPartnerships Dr.Frederick Ognibene.Engineers ChristopherStanley (in front) andLindsey Bellini demonstratedthe capabilities ofthe newly updated ClinicalMovement AnalysisLab. CTSA fellows alsovisited the new CC Pharmacy DepartmentPharmaceutical Development Section facilityand the National Heart, Lung, and Blood InstituteVascular Biology research area.Staying in touch with alumniBy connecting with alumni of our trainingprograms, the Clinical Center is ableto answer the questions,“Where are theynow, and what are they doing?” Thisreveals success stories of alumni, aswell as whether our training programsare setting students up for a career inclinical and translational research as theyaim to do.The CC’s OCRTME alreadyhas data collection mechanisms in placefor the Clinical Research TrainingProgram (CRTP) and Graduate MedicalEducation (GME) and is working onexpanding to all of our training programs.In addition, OCRTME uses Facebookand Twitter to stay in touch with alumni.For example, the CRTP alumni group onFacebook has 66 members who canconverse with each other, as well as readnews about the CRTP posted by OCRT-ME staff. And the alumni e-newsletterlaunched in December 2010, with plansto distribute quarterly, allows the CC toprovide detailed updates to alumni.ANNUAL REPORT 2011• 41

FACULTY BRING CLINICAL RESEARCH COURSE TO NIGERIAAfter hearing that the CC brought IPPCR toChina in 2008, Olopade asked,“Why notNigeria?” (her native country), recalled professorDr. Laura Lee Johnson, statistician in the Officeof Clinical and Regulatory Affairs at the NationalCenter for Complementary and AlternativeMedicine.About 90 people attended the course in Nigeria,ranging from heads of departments to fellows.Highlights of IPPCR—data safety monitoring,epidemiological design, ethical issues, communityengagement—brought a new perspective to thestudents.Nigerian investigators were interested in “all-overthe-mapresearch,” Johnson said. From nutritionalchoices to encourage fertility to eye disorders,pregnancy-related issues to parasitic diseases, thestudents asked about a variety of studies, Johnsonreported.Dr. Charles Natanson, headof the anesthesia section inthe CC Critical CareMedicine Department,lectured during theIPPCR course in Nigeriain May 2010.The course Introduction to the Principles and Practicesof Clinical Research (IPPCR) was presented atthe University of Ibadan, Nigeria, in May 2010.Co-sponsors were the Clinical Center, the NIHFogarty International Center, and the Universityof Chicago Global Health Initiative.“This was thefirst time an adaptation of this course, which wasdeveloped by the Clinical Center, has been taughtin sub-Saharan Africa,” noted Dr. John I. Gallin,CC director and lead of the NIH faculty.Faculty members traveled to the most populousnation in sub-Saharan Africa for four days of classesand conversations.They touched on highlightsof the course that is offered annually at the CCand videocast to locations around the world. Dr.Olufunmilayo (Funmi) Olopade,Walter L. PalmerDistinguished Service Professor in Medicine andHuman Genetics and director of the Center forClinical Cancer Genetics at The University ofChicago, learned of IPPCR while on the NIHAdvisory Board for Clinical Research.To continue the education of Nigerian researchers,the local coordination group helped assemble asustainability team of participants who were youngIbadan faculty.The team will keep the training goingfor other cohorts,“so it’s not just a single shot,and we walk away,” Johnson said.NIH and HHS faculty who went to Nigeria wereGallin; Johnson; Dr. Charles Natanson, CCCritical Care Medicine Department; and Dr. JerryA. Menikoff, director, Office for Human ResearchProtections, Office of Public Health and Science,Office of the Secretary, Department of Health andHuman Services.They were accompanied byDr. Letitia Robinson of the NIH FogartyInternational Center.Also teaching wereDr. Oladosu A. Ojengbede, University CollegeHospital, Ibadan, Nigeria; Dr. Christopher‘Sola’ Olopade, University of Chicago; andDr. Olufunmilayo (Funmi) I. Olopade.42 • ANNUAL REPORT 2011

COLLABORATION OFFERS CLINICAL CENTER RESOURCES TOEXTERNAL INVESTIGATORSA new pilot partnership between the ClinicalCenter, the National Cancer Institute’s Centerfor Cancer Research, and the Damon RunyonCancer Research Foundation will offer some ofthe capabilities and expertise of America’s researchhospital to an external group of clinical investigatorsin cancer research.The special talent andresources of the NIH will allow Damon Runyonfundedinvestigators to undertake studies and collaborationsthat will advance understanding of theprevention, diagnosis, and treatment of cancer.Damon Runyon Clinical Investigators (DRCIs)are early career physician-scientists whose focus ison the translation of basic science discoveries intopractical therapies. Since 1946, the Damon RunyonCancer Research Foundation has investedmore than $230 million in early career cancer researcherswho have the energy, drive, and creativityto become leading innovators in their fields.“Thanks to the new three-component partnership,these young investigators can apply to use certainequipment, facilities, and patient cohorts at theClinical Center in research collaborations withNIH clinician-scientists,” said Dr. John I. Gallin,Clinical Center director.An approved research proposal could also provideaccess to select research materials, services, orproducts that may not be available or possible attheir home institutions—such as products fromthe Pharmacy Department’s PharmaceuticalDevelopment Facility—through arrangementswith the Clinical Center but without a formalresearch collaboration with a specific institute.If the pilot proves successful, the NIH and theClinical Center may pursue similar partnershipswith other NIH institutes and centers and externalorganizations.“This is a first step toward opening the doors ofthe Clinical Center to a new group of clinicianscientists,further supporting the NIH mission toenhance health and reduce the burden of disease,”said Gallin.The partnership allows DRCIs to partnerwith an NIH-tenured or tenure-track investigatoron a research project. If the NIH researchpartner is not identified independently, the DRCIcan submit a research proposal to NCI and theNICHD endocrinologist named 2010Distinguished Clinical TeacherThe 2010 Distinguished Clinical Teacher Award went to an investigator with a“logical and thorough” teaching style, according to the fellows who work withhim. Dr. Jeffrey Baron, chief of the Section on Growth and Development at theNational Institute for Child Health and Human Development, received the awardin September 2010.The Distinguished Clinical Teacher Award has been presented each year since 1985to an NIH faculty member who demonstrates excellence in mentoring healthcareprofessionals and has made outstanding contributions to the advancement ofclinical research.The recipient is chosen by the Clinical Center Clinical Fellow’sCommittee and delivers the annual John Laws Decker Memorial Lecture thefollowing spring.Dr. Jeffrey Baron (left) received the 2010Distinguished Clinical Teacher Award. With him isDr. Joo Song, chair of the CC Clinical FellowsCommittee.Also nominated this year were Dr.Alan Decherney (NICHD), Dr.Theo Heller(NIDDK), Dr. Steven Warach (NINDS), Dr. Juan Gea-Banacloche (NCI), andDr. Susumu Sato (NINDS).ANNUAL REPORT 2011• 43

Clinical Center for assistance in identifying a suitablecollaborator. A scientist applying for a DamonRunyon Cancer Research Foundation ClinicalInvestigator Award could apply with a mentorfrom NCI or another NIH institute or center.The application would identify the research to bedone and the resources used at the Clinical Center.“We are thrilled to offer these opportunities andresources to the clinical investigators we fund,” saidLorraine Egan, executive director of the DamonRunyon Cancer Research Foundation.To facilitatethese partnerships, the Clinical Center andNCI’s Center for Cancer Research will create anannually updated portfolio of ongoing researchand of the research interests of NIH investigators.In addition to scientific collaborations, this pilotpartnership will provide interested DRCIsopportunities to participate in the ClinicalCenter’s clinical research training curriculum.Courses are Introduction to the Principles andPractice of Clinical Research, Principles of ClinicalPharmacology, and Ethical and Regulatory Aspectsof Clinical Research. Damon Runyon ClinicalInvestigators also are invited to apply to theClinical Center Sabbatical in Clinical ResearchManagement.Clinical Research Training Programgathers best from across theUnited StatesThe 2010-2011 Clinical Research TrainingProgram class of fellows represents universitiesfrom coast to coast, pulling medical studentsfrom Boston University School of Medicine;Louisiana State University School of Medicine;and the David Geffen School of Medicine at theUniversity of California, Los Angeles, to name afew.The program—directed by the Clinical CenterOffice of Clinical Research Training andMedical Education—brings medical and dentalstudents to the NIH campus for 12 months ofmentored clinical or translational research in anarea that matches the fellows’ personal researchinterests and career goals.44 • ANNUAL REPORT 2011

CLINICAL CENTER OFFERS SABBATICAL IN CLINICALRESEARCH MANAGEMENTThe Clinical Center’s Sabbatical in ClinicalResearch Management program provides wideaccess to the knowledge, expertise, and experienceof leaders at the NIH.The program started accepting applications in2009 from a limited number of those who areexperienced in the world of clinical research butwant to learn more about management of a clinicalresearch enterprise.The four participants inthe pilot phase of the sabbatical program chose anindividualized set of electives and received oneon-oneattention from managers, executives, andclinician-scientists.The elective leaders are mainlyfrom the CC, but other educational partnersinclude other NIH institutes and centers, the USFood and Drug Administration (FDA), the HHSOffice for Human Research Protections, and theFoundation for the NIH.Dr. Roman Ivanov traveled from Russia to participatein the Sabbatical in Clinical Research Managementfor three months in 2010.As a researcherat both a biotechnology company and an academicmedical center, Ivanov was curious to learn aboutprotocol writing and tracking and patient recruitment,as well as the regulatory aspects of clinicalresearch. Spending a month full-time at theFDA and two months at the NIH developingan ongoing project allowed him to meet hiseducational goals.“The program provided me with a uniqueopportunity to get a better understanding of theinfrastructure required for investigator-associatedclinical trials and regulatory issues associated withthem. I will do my best to share this knowledgewith my colleagues and I hope that this willontribute to development of medical sciencein Russia,” Ivanov said.This is a major goal of the sabbatical program:giving participants hands-on experience in clinicalresearch management so that they may apply whatthey learn at their home institutions. Opening theCC’s doors allows individuals to learn from thescience, the management and operations, and theunique circumstances under which we conductclinical and translational research conducted here.“This program provides management training tohelp ensure that medical research programs are safe,ethical, and efficient,” said CC Director Dr. JohnI. Gallin.“The sabbatical will help demystify thecomplexities of governmental regulatory agencieswhile providing an opportunity to achieveexcellence in clinical research management.”ANNUAL REPORT 2011• 45

TRAINEE FORUM INTRODUCES FUTURE COLLABORATORSA panel of alumni of the researchtraining programs that CISTForum attendees are in sharedtheir journeys and gave advice tothe current trainees.Despite the presence of NIH institute and centerdirectors, distinguished researchers, and even NIHDirector Dr. Francis S. Collins, some of the mostimportant people young clinician-scientists met ata forum in November were those sitting next tothem in the auditorium seats.The Eighth annual Clinical Investigator StudentTrainee (CIST) Forum—developed and hosted bythe Clinical Center Office of Clinical ResearchTraining and Medical Education—convened morethan 260 medical, dental, and veterinary students inyear-long enrichment programs at academic medicalcenters and at the NIH for two days of panels,tours, and networking.“You are what we call, in epidemiology, a cohort,”said NIH Deputy Director for Intramural ResearchDr. Michael Gottesman.“Look to your left andyour right.These are the people who will be yourcollaborators.These are the people who will bereviewing your grant applications.”In addition to the opportunity to talk shop withtheir peers, the CIST Forum presented fellowsand scholars access to possible mentors and leadersin their fields of interest. Leaders of the CC,the National Institute of Biomedical Imaging andBioengineering, the Fogarty International Center,and the National Institute on Drug Abuse spokeon the latest from their groups. Forum attendeescould speak with investigators from their intendedresearch areas at networking luncheons, and a panelon genomics and genetics elicited much interestfrom the students.Another popular panel was the group of alumnifrom the same programs as CIST Forum attendees.Dr. Eric Adler, assistant professor of cardiology andmedicine at Oregon Health Sciences Universityand a former Sarnoff Fellow, kept the crowd laughing,as he referred to content from NIDA DirectorDr. NoraVolkow’s presentation.“I was addicted to science,” he said.“Find somethingyou’re addicted to, but not something destructivelike methamphetamines.”Panelist Dr.Adam M. Zanation, assistant professorin the Department of Otolaryngology at Universityof North Carolina School of Medicine andformer Doris Duke Charitable Foundation fellow,reflected,“Being a successful researcher is aboutcommitment, effort, and having good ideas.”The other two panelists were Dr. Karen E. Hoffman,assistant professor in the Department of RadiationOncology at the University of Texas MDAnderson Cancer Center and former CC ClinicalResearch Training Program (CRTP) fellow, andDr. Jayanta Debnath, assistant professor in theDepartment of Pathology at the University ofCalifornia, San Francisco Medical Center andformer Howard Hughes Medical Institute-NIHresearch scholar. [Read about Hoffman’s journeyfrom CRTP to clinical research at a premieracademic medical institute on page 47]For the second year, CIST Forum organizers usedsocial media to appeal to their millennium generationaudience. Students asked questions and staffprovided helpful links through tweets marked withthe hashtag #CIST8, which were displayed on theMasur Auditorium screen during question-andanswersessions and breaks.Additionally, onlinenetworking linked attendees and organizers beforethe conference—getting them need-to-knowinformation and letting them coordinate travel.Tours of CC units allowed forum attendees tosee first-hand the cutting-edge facilities that allowthe groundbreaking work of the NIH intramuralprogram.Lauren Stossel, a Doris Duke Charitable Foundationfellow from the Mount Sinai School ofMedicine, visited the new Pharmacy Department’sPharmaceutical Development Section and46 • ANNUAL REPORT 2011

Rehabilitation Medicine Department’s ClinicalMovement Analysis Laboratory.“I thought it wasreally interesting,” she said.“They demonstrated thedifferent technologies and showed us the clinicalcorrelates.”The keynote speaker of the forum—NIHDirector Collins—addressed the importance oftranslating basic science discoveries into new andbetter treatments and how the NIH is putting scienceto work for the benefit for health care reform.Collins also discussed what the NIHis doing to encourage innovation and empoweryoung researchers like CIST Forum attendees.“As the director of the NIH, one of the thingsthat I enjoy most is the opportunity to brainstorm,particularly with people that are going to lead ourfield in the future, and that is all of you, about thedirections that science is taking that are going to beparticularly transformative,” he said.Collins closed his speech with a musicalperformance on his double helix-inlayed guitar:a self-penned update about DNA to the tune ofDel Shannon’s 1960’s hit “Runaway.”“Dr. Collins was amazing. He’s like the supermanof scientists,” said CRTP fellow Hari Trivedifrom the Medical College of Georgia.Above all,for many of the forum attendees, though, was thechance to walk away with new contacts.“These are going to be my future colleagues, futurecollaborators, and people who I’ll be seeing overand over again. So getting to know them now,at this early stage, is going to be beneficial forfostering those relationships,” said Shah Ali of theStanford University School of Medicine, a HowardHughes Medical Institute fellow.NIH Director Dr. Francis S.Collins serenaded CIST Forumattendees with a personalizedversion of “Runaway” after hiskeynote speech.Former CRTP fellow reflects on influence of programThe NIH Clinical Research Training Program(CRTP) aims to prepare the next generation ofclinician-scientists through a year of immersionin the NIH intramural program. One alumna ofthe program recently returned to speak on herexperience and to inspire her successors.Karen Hoffman, assistant professaor in the Departmentof Radiation Oncology at The Universityof Texas MD Anderson Cancer Center, spokeon a panel of graduates of the year-long researchprograms represented at the Clinical InvestigatorStudent Trainee Forum, which was held in theClinical Center in November. She was part of theCRTP class of 2001-2002.The CRTP competitivelyselects participants, known as fellows,to spend a year engaged in a mentored clinicalor translational research project in an area thatmatches their clinical research interests and goals.Hoffman did her undergraduate work at theUniversity ofVirginia and earned her medicaldegree from Duke University. She also holds aMaster of Public Health from the Harvard Schoolof Public Health and Master of Health Science inClinical Research from Duke University.Whilein the CRTP, Hoffman researched the late effectsof treatment in long term survivors of pediatricsarcoma with Dr. Patrick Mansky, formerly ofthe National Center for Complementary andAlternative Medicine, and genetic and hormonalregulation of osteosarcoma metastasis with Drs.Lee Helman and Chand Khanna of the NationalCancer Institute Center for Cancer Research.“My experience here in the CRTP helpedlaunch my career,” she said.“It really helped medevelop the thought process to formulate researchquestions and provided the skills to pursue myindependent work.”At MD Anderson, Hoffman conducts prostateand breast cancer clinical research. Her time issplit with 75 percent devoted to clinical practiceand 25 percent to research. She enjoys theinteraction with patients this balance allows her,Hoffman said.Dr. Karen Hoffman,part of the 2001-2002Clinical ResearchTraining Program class,is now assistant professorin the Department ofRadiation Oncology atthe University of TexasMD Anderson CancerCenter.ANNUAL REPORT 2011• 47

Organizational Improvement/Teamwork WEEK CELEBRATES VOLUNTEERS’ TIME AND TALENTSVolunteers contribute about 30,000 hours a yearto the Clinical Center and the CC honoredthem during NationalVolunteer Week in April2010.“Volunteers add a tremendous amount ofsupport to the Clinical Center,” said CourtneyDuncan,Volunteer Services coordinator.“They bring excitement, genuine interest,and willingness to learn.”The CC volunteer squadincludes (back, from left)Janet Logan, Victor Canino,Vickie Campbell, and (front,from left) Kristopher Yoon,Louise Gorman, andJeanette Ferris.Volunteers Mark and MichelleCohen (from left) with progrmcoordinator Courtney Duncan.The 17th annual CC volunteer appreciationevent on April 22 included presentation of specialrecognition awards to nine volunteers based onconsistency, reliability, hours spent, or “generaloverall wonderfulness,” as Duncan said. Honoredwere: Mark and Michelle Cohen, animal-assistedtherapy program; Eileen De Santillana and MonicaSullivan, language interpreters program; JoanneHill, Armen Thomasian, and Cynthia Kim, patientambassador program; Saroja Kanesa-Thasan, RedCross; and Janet Logan, volunteering in OutpatientClinic 12 for 14 years.(upper right)Kerry Bruton sends a box ofsurgical gloves to a patientunit using the tele-car system.Smaller items travel throughthe CC’s tube system.(lower right)Connie Williams, sterilesupply technician, organizesmetal instruments for sterilizationwith heat/steam. Staffalso manage sterilization ofitems using low temperaturemethods such as ethyleneoxide gas and vaporized hydrogenperoxide.Tools of the tradeBandages, needles, sterile equipment, and isolationcarts are necessary items in any hospital, and theClinical Center is no different.The group thatassures such specialized items are provided isCentral Hospital Supply (CHS).“We are the hub of this Clinical Center.The doctorsand nurses couldn’t do their job without supplies,”said medical supply technician Kerry Bruton.To use the system, clinical staff log on to the stationand press a take or return button on the bin of theirselected item.This crucial step links to the CHSinventory to alert staff when they need to replenishthe machine’s supply. Completing this step ratherthan simply taking an item or putting one backwithout registering the action is crucial to help CHSequip the units with what they need.“CHS, in a team effort, achieves excellence incustomer service by providing safe medical-surgicalsupplies in a cost-effective and timely manner forclinical care and protocol support,” said Paula Wrenn,chief of CHS.48 • ANNUAL REPORT 2011

Some volunteers use their contribution as a wayto try out an area of interest.Tiffany Murray (atright, with her supervisor Justine Harris) workedas a pharmacy technician in a retail setting, butwondered if she would prefer work in a hospitalsetting. Murray offered some advice to thoselooking to get the most out of their volunteeropportunity:“Be dependable and committed …Grasp everything.Ask questions.”MORE ABOUTVOLUNTEERSTo learn about volunteeropenings and to apply,visit http://clinicalcenter.nih.gov/volunteers.Post-baccalaureate Intramural Training ResearchAward fellows (post-bac IRTAs to NIH insiders)spend a year or two at NIH between theirundergraduate studies and pursuit of an advanceddegree. For those with plans to apply to medicalschool, the CCVolunteer Program offers patientcareexperience. Volunteering in patient-care areassupplements IRTAs’ laboratory or administrativeassignments to humanize translational researchand develop skills not found in a textbook.“I think one of the most important parts ofbeing a doctor, no matter your specialty, isknowing how to communicate,” said Nizar Dowla(at right with microphone), a fellow with theCC Rehabilitation Medicine Department whoplans to pursue a career in pediatrics. Dowlaspent two hours a week in the department’smain playroom, interacting with kids.SWEET TREATS WIN SMILESThe Seventh Annual Clinical Center Gingerbread House Contest made a sweetappearance again in 2010. Entries were displayed in the Hatfield Building atriumthrough the December holiday season. Patients, staff, and visitors cast ballots for theirfavorite.This year’s competition drew 28 entries and more than 2,500 ballots cast.First place went to the 3NE Disney firehouse, with the 3SE North Toy Story 3 insecond, and 7SE Alice in Wonderland taking third.WJLA featured the Clinical Center’sgingerbread house competition in a “Good Morning,Washington!” segment withDr. Clare Hastings, chief nursing officer, leading the welcoming cheer.ANNUAL REPORT 2011• 49

EMERGENCY PREPAREDNESS PARTNERSHIP PUT TO THE TEST IN DRILLMary Beth Price (right) fromNursing and Patient CareServices welcomed mockpatient Lynne Spivack to theClinical Center as AdamRussell of Hospitality Servicestook her to the triage area.Jacqualine Reid (far right),CC director’s office, managedthe flow of electronic patientdata through the medicalinformation transfer systemat the drill.Clinical Center staff prepared for the worst onOctober 14, 2010, with the sixth-annual multiagencyEmergency Preparedness Exercise.Thedrill is a simulation of how area medical facilitieswould handle a catastrophic event.The CCpracticed managing an overflow of patients fromDC hospitals that were “full” after a fictional eventcaused a large volume of casualties.The Bethesda Hospitals’ Emergency PreparednessPartnership—consisting of the National NavalMedical Center, Suburban Hospital Health CareSystem, the CC, the National Library of Medicine,and the NIH Fire Department and HazardousResponse Units—was formed in 2004 to standready to provide a rapid and sustained medicalresponse to the community during a catastrophicevent in the National Capital Region.For the first time CC employees simulated triagingand admitting stable patients from both theNational Naval Medical Center and SuburbanHospital Health Care System. In prior years, mockpatients were transported only from SuburbanHospital.Command centers communicated clearly andefficiently through a variety of avenues, fromradio communication compliments of the NIHRadio Amateur Club to videophones that allowedcallers to speak “face-to-face” on small screens ineach command center.Members of the NIH community—staff from across institutes andcenters and their families—bandedto form Team NIH at the Susan G.Komen Global Race for the Cure onthe National Mall in Washington, DC,on June 5, 2010.50 • ANNUAL REPORT 2011

HOSPITAL WELCOMES PROJECT SEARCH INTERNSTwelve new interns arrived at the Clinical Centerin September 2010 through a partnership withProject SEARCH, an international organization,for a 30-week unpaid internship.Project SEARCH works with hospitals and businessesin the United States, the United Kingdom,and Australia to provide opportunities for youngadults with disabilities to learn employability skillsand gain work experience.The CC launched this intern program as a pilotunder the management of Denise Ford, chief ofthe Office of Hospitality Services, and as part ofthe CCVolunteer Program.“This will help people see beyond the disabilityand understand the interns as contributing membersof our workforce,” Ford said.“It’s a win all theway around.”The ultimate aim for young people in the ProjectSEARCH program is competitive employment.Chief of the Office of HospitalityServices Denise Ford led atour in July 2010 for some ofthe 12 interns who now workat the Clinical Center througha partnership with ProjectSEARCH. From left are VanBerg, Aamer Khan, Ricky Day,Crystal Battle, Ashton Bell,Amethyst Thornton, andJustin Haynes.NURSES WEEK 2010 CELEBRATES CREATING A CLINICAL RESEARCH SPECIALTYAt the opening ceremony of 2010 Nurses Week,Clinical Center Chief Nurse Officer Dr. ClareHastings referenced the influence the CC hasin the network of Clinical Translational ScienceAwards consortium institutions and NIH-fundedcenters across the country that perform clinicalresearch.“We represent the flagship that peoplelook to for leadership in this whole structure,”she said.Hastings thanked the nurses for their developmentof the domain of practice for the specialty ofclinical research nursing as part of the ClinicalResearch Nursing 2010 initiative. Depending ontheir role—for example, clinical research nurse,research nursing coordinator—nurses balance theirdays among the different dimensions, Hastings said.The five foci of the specialty of clinical researchnursing are clinical practice, study management,human subjects protection, contributing to thescience, and care coordination and continuity.ANNUAL REPORT 2011• 51

PATIENT CARE PERSEVERES THROUGH SNOWPOCALYPSECC staff banded together to provide round-theclockcare for more than 170 patients over thefederal government closure from noon Friday,February 5, through Thursday, February 11.This area has faced storms before that have complicatedoperations, but the twin blizzards of 2010posed a greater challenge.“It was worse for tworeasons,” said Dr. John I. Gallin, CC director.“One, the duration and severity of the storm.And two, we had more patients in the hospitalthan we’ve had in the past.”Patient care and researchcontinued at the ClinicalCenter through the twinblizzards of February 2010.CRTP fellow Zachary Dezmansnapped this as he skied tothe hospital.It may have seemed that the Washington, DC, metropolitanarea shut down for a week in early Februaryas two snowstorms rendered roads impassableand left hundreds of thousands without power.The needs of Clinical Center patients remainedconstant, though, even as the weather patterns ofthe mid-Atlantic did not.Staff stayed overnight and worked double shifts tokeep patients safe and on track with their treatments.TheCC provided beds for 304 employees,and The Children’s Inn lent their few vacancies.More than 54 staff with four-wheel drive vehiclesvolunteered to transport those without betweentheir homes and the hospital.“I was just astounded by the level of energy, thecommitment, and the cooperation. Even with ablizzard outside, there wasn’t anything going oninside that would indicate people were doinganything but focusing on patients,” said MaureenGormley, chief operating officerFantastic voyageThe Clinical Center hosted multipleevents on Take Your Child to WorkDay on April 22, 2010, including aninside look at imaging, veterinaryservices, and anesthesia. Departmentof Laboratory Medicine stafferTor Moore (right) led “Fantastic VoyageThrough the DLM” where visitorsdressed up like medical technologists;performed laboratory tests;used microscopes to view microorganisms,parasites, and blood cells;learned how to collect specimens;and practiced using different laboratoryequipment.52 • ANNUAL REPORT 2011

CLINICAL CENTER RUNNERS SPEED THROUGH THE NIH RELAYSix Clinical Center teams participated in the27th NIH Relay in September 2010. The besttime from a CC team came from Rehab Medicine’sPush(1)ng our Gluteus to the Maximus,one of the department’s three teams in the competition.They came in 10th overall by finishing in15:47. The CC Cheetahs entered for the first yearwith runners from across Clinical Center.(Left) Cells R Us from the Department of TransfusionMedicine Cell Processing Section entered(from left) Luciano Castiello, Angela Pickett, JeanGildner, Hugo Luizaga Diaz, and Thai Truong.The Drug Runners from the Clinical CenterPharmacy Department included (from left)Schaun Norman, Thomas Dorworth, SaraAbshari, Jordan Petit, and Rose Pauline.NEW CORRIDOR STREAMLINESBUILDING TRANSITIONAfter more than a year of detours and construction, a new main corridorfrom the Clinical Center south entrance to the Hatfield Building makesnavigating the hospital easier.Additionally, the updated Phlebotomy andEKG Heart Station units (two of the Clinical Center’s most frequentedpatient-care areas) now enjoy a larger, brighter waiting area.ANNUAL REPORT 2011• 53

NoteworthyMaryland governor visitsGovernor Martin O’Malley (right) met with NIHleaders and toured the Clinical Center before addressingthe Federal Facilities Advisory Board onNovember 18, 2010.The governor appointed theboard last year to develop a comprehensive assessmentof how Maryland can best support andleverage the vast potential of its more than 50federal facilities and help connect Marylandcompanies with federal opportunities to createjobs. Greeting him were (from left) CC DirectorDr. John I. Gallin; Dr. Griffin P. Rodgers, directorof the National Institute of Diabetes and Digestiveand Kidney Diseases; and Dr. Francis S. Collins,NIH director.2010 NIH director’s awardsReceiving 2010 NIH Director’s Awards were:The CC Blizzard Response Team, for extensiveefforts behind the scenes that kept the hospitaloperational during winter 2010 blizzards.Teammembers were Tannia P. Cartledge, Sean D. Dancy,Beverly Farrington, Monique Harrison, RodneyHigginbotham, Ronald Jones, Karen Kaczorowski,Travis Palmer, James Rowe, Michael Sandifer, andYvonne O. Scypion.As part of the Traumatic Brain Injury Teamhonored for effective collaboration in earlyimplementation of the Congressionally establishedresearch initiative in traumatic brain injury, Dr.David A. Bluemke, director of Radiology andImaging Sciences, and Dr. Leighton Chan, chiefof the Rehabilitation Medicine Department,were given director’s awards.A Ruth L. Kirschstein Mentoring Award wentto Dr. Juan Lertora, director of the ClinicalPharmacology Program, for exemplaryperformance while demonstrating significantleadership, skill, and ability as a mentor.Dinora Dominguez and Frinny Rocio Polancowere among those noted for participation intheVolunteer Program for English Proficiencythat creates an opportunity for NIH nonprofessional/non-scientificstaff to improvetheir communication skills.The Long-Term Administrative ServicesContract Team honored for contributions tothe goal of reducing the need for multipleindividual contracts included Lynda Ray.Patricia Coffey, director of the Medical RecordDepartment, was honored for shepherding theCC toward an electronic patient record.5 4 • ANNUAL REPORT 2011

Marincola leads international societyDr. Francesco Marincola,chief of the InfectiousDisease and ImmunogeneticsSection in theDepartment of TransfusionMedicine, is servingas vice president of theInternational Societyfor Biological Therapiesfor Cancer (iSBTc) andwill become presidentDr. Francesco Marincolain 2012. He has been amember of iSBTc since2000 and sat on the board of directors from 2004to 2007. During his tenure, he hopes to supportthe continued advancement of immunotherapiesfor malignancies and to increase participationfrom members outside the United States.“It’s a year where things are really happening inthe field,” Marincola said.“Being president, youhave an ability to influence.”Marincola’s research focuses on at what makessome people respond to immunotherapies, suchas interleuken-2, while others do not. Only about10 percent of patients see an advanced positiveresponse to such treatment, Marincola said.The iSBTc held the Symposium on Immuno-Oncology Biomarkers, 2010 and Beyond: Perspectivesfrom the iSBTc Biomarker Task Force inMasur Auditorium on September 30, 2010.Informatics staff recognizedThe Clinical Center Department of ClinicalResearch Informatics received a 2010 Circle ofExcellence Award from health-care companyAllscripts for achievements in using advancedtechnology to improve patient-care quality.The department responded to the CC goal ofimproving the percentage of doctors who signedtheir orders within 72 hours of entry from 50 to90 percent. In mid-2010, the department deployeda medication logic module within the ClinicalResearch Information System.The new modulepresents the signature manager screen to physicianswith unsigned orders at login. Countersignaturecompliance almost immediately rose to 90 percentand has remained theresince implementation.This capability improvedregulatory complianceand patient safety byensuring that orders arepromptly reviewed bythe appropriate provider.The Circle of ExcellenceAward recognizes healthcareorganizations fordemonstrating significantachievements in the areasof process improvement,clinical adoption, andcollaboration.Additionally, Lincoln Farnum, CCdeveloper and clinical analyst, was recognized forhis participation in the Allscripts ClientConnectprogram and advisory group.“Chefs Move to Schools” campaignThere are two ways to get kids to eat healthy food,says Robert Hedetniemi, certified executive cheffor the Clinical Center’s Nutrition Department—you can trick them or you can teach them.“It’s tough to get kids to eat stuff they aren’t accustomedto.The way I see it, you can either hide it inthings that they like, or you can get them involvedin the cooking process,” he said.Hedetniemi has recently joined the ranks of individualsand organizations supporting First LadyMichelle Obama’s Lets Move! campaign to solvethe childhood obesity epidemic within a generation.He is one of hundreds of chefs from acrossthe country who have signed up to be part of the“Chefs Move to Schools” initiative, a program thatpairs chefs with community schools to help teachyoung people about nutrition.Run through the US Department of Agriculture,“Chefs Move to Schools” asks culinary professionalsto create healthy meals that meet the schools’dietary guidelines and budgets.The chefs andschools—kindergarten through grade 12—willalso work together to teach young people aboutnutrition and making balanced and healthy choices.CC executive chef RobertHedetniemi turns up theheat in a demonstration forNutrition Department staffmembers Janet Hoey (left)and Christina Johnson.ANNUAL REPORT 2011• 55

In her opening remarks at the kickoff rally, FirstLady Michelle Obama explained the severity ofthe problems associated with childhood obesity.“You all know the statistics when it comes to thehealth of our kids—and they’re staggering, everytime we talk about it—how nearly one-third ofchildren in this country are now overweight orobese.That’s one in three. Just think about that.That means that these kids are at greater risk ofobesity-related diseases—you name them, cancer,heart disease, stroke,” she said.Hedetniemi agrees.“If we don’t do somethingabout it now, we are going to have a generationof kids with extreme health problems who aregoing to grow up into adults with extreme healthproblems,” he said.“We have an opportunity nowto intervene, and from my little role I think I canexpose some kids to some really cool products tohelp them get excited about nutrition.”Murray receives microbiology awardDr. Patrick R.Murray, chief of theClinical MicrobiologyService in the ClinicalCenter Department ofLaboratory Medicine, andan American Society ofMicrobiology (ASM)member since 1974, waschosen to receive theDr. Patrick R. Murray ASM Founders Distin-guished Service Award. Murray has been anactive ASM volunteer since 1981 and is honoredfor his years of service to multiple programs.He was editor-in-chief of four consecutiveeditions of the Manual of Clinical Microbiology andserved for 15 years on the editorial board and asan editor of the Journal of Clinical Microbiology.Henderson gives SHEA lectureClinical Center DeputyDirector for ClinicalCare Dr. David Hendersongave the Society forHealthcare Epidemiologyof America (SHEA) Lectureon March 20, 2010,at the Fifth DecennialInternational ConferenceDr. David Hendersonon Healthcare-AssociatedOutcomes.A member ofSHEA for the last twodecades, Henderson was chosen by the society’sboard of trustees.The SHEA Lectureship recognizesthe career contributions of one senior investigatorin infection prevention and control andhealth-care epidemiology each year. Henderson’spresentation “Opportunists and Opportunities”reviewed his 30 years as a hospital epidemiologistat the CC and commented on options for andbarriers to the society’s success.Former recipients of the SHEA Annual Lectureshipinclude such distinguished hospital epidemiologistsas Dr. Robert Weinstein of Rush MedicalLasker Foundation directors tourunique spaceThe Albert and Mary Lasker Foundation—dedicated to the support of biomedical researchtoward conquering disease, improving humanhealth, and extending life—held its board ofdirectors meeting at the NIH on April 20, 2010.Clinical Center Director Dr. John I. Gallin (inlab coat) gave the visitors a tour of the hospital,including its interstitial space between floors.This unique feature of the CC allows for adjustmentsand repairs to be made to settings suchas air flow and water supply without disruptingclinical care and research.56 • ANNUAL REPORT 2011

College; Dr. Dennis Maki of the University ofWisconsin; Dr. Didier Pittet from Geneva, Switzerland;Dr. Richard Wenzel of the Medical College ofVirginia; and Dr. Glen Mayhall from the Universityof Texas.In addition to his lecture, Henderson gave threeplatform presentations at the conference, includingan opening plenary talk titled “Charting theCourse for the Future of Science in HealthcareEpidemiology” and a symposium presentationabout managing providers infected with bloodbornepathogens. He also conducted a workshopon occupational health. Conference co-sponsorswere SHEA; the Centers for Disease Control andPrevention; the Association for Professionals inInfection Control and Epidemiology, Inc.; and theInfectious Diseases Society of America.Ognibene honoredDr. Frederick P. Ognibene (below right), deputydirector for educational affairs and strategic partnerships,received the Society of Critical CareMedicine (SCCM) 2009 Distinguished ServiceAward for exceptional leadership contributions tothe society. Dr. Mitchell Levy, 2009 SCCM president,presented the award. Ognibene was presidentof the SCCM in 2007 and served nine years onits governing council and executive committee.In 2010, Ognibene was one of 59 individualselected to the Association of American Physicians.The goals of the association include the pursuit ofmedical knowledge and the advancement throughexperimentation and discovery of basic and clinicalscience and their application to clinical medicine.Each year, individuals having attained excellence inachieving these goals are recognized by nominationfor membership by the council of the association.Patient Advisory Group memberSusan Lowell Butler rememberedThe Clinical Center lost a longtime friendwhen Susan Lowell Butler died on December18, 2010.Active with the CC since she soughttreatment here for a simultaneous diagnosis ofbreast and ovarian cancer in 1995, Butler wasan original member of the Patient AdvisoryGroup and the consumer representative on theNIH Advisory Board for Clinical Research.She received the 2004 CC Director’s Awardfor commitment to enhancing patient care.Butler was a keynote speaker at the dedicationceremonies for the new Mark O. HatfieldClinical Research Center in 2004 and wasselected to be the patient greeter of PresidentBarack Obama during his 2009 visit. Sheserved as a faculty lecturer for the CC courseIntroduction to the Principles and Practices ofClinical Research and contributed the onlypatient-written chapter to the course’stextbook.“Susan gave her time, her energy, and her loveto the Clinical Center and to all of us,” saidCC Director Dr. John I. Gallin.“Her words atthe dedication of the new Hatfield Buildingincluded the phrase ‘the house of hope’—words repeated many times since. Her courageand strength touched and inspired all whoknew her and we will miss her terribly.”One of the first facesPresident Barack Obamasaw upon entering theClinical Center onSeptember 30, 2009, wasthat of longtime patientadvisory group memberSusan Lowell Butler.ANNUAL REPORT 2011• 57

Organization and GovernanceADVISORY BOARD FOR CLINICAL RESEARCHNATIONAL INSTITUTES OF HEALTH (2010)*GovernanceThe NIH Advisory Boardfor Clinical Research overseesthe Clinical Center’sresources, planning, andoperations.The Board alsoadvises on NIH’s overall intramuralprogram, includingpriority setting, the integrationand implementationof research programs of theindividual institutes andcenters, and overall strategicplanning for the intramuralprogram.Comprised of NIH clinicaland scientific leaders andoutside experts in managementof health care andclinical research, theBoard advises the NIH deputydirector for intramuralresearch and the ClinicalCenter director and reportsto the NIH director.CHAIR: Michael J. Klag, MD, MPHDeanJohns Hopkins BloombergSchool of Public HealthVICE-CHAIR: Martin Blaser, MDChairman, NewYork UniversityMedical Center Department of MedicineFrederick H. King Professor of Internal MedicineJosephine Briggs, MDDirector, National Center for Complementaryand Alternative MedicineElizabeth B. Concordia, BA, MASExecutiveVice PresidentUniversity of Pittsburgh Medical CenterPresidentHospital and Community Services DivisionMichael Rutledge DeBaun, MD, MPHProfessor of PediatricsVice Chair for Clinical AffairsDirector forVanderbilt-Meharry Center ofExcellance in Sickle Cell DiseaseVanderbilt Children’s HospitalJoe G. N.“Skip” Garcia, MDVice Chancellor for ResearchProfessor of MedicineUniversity of Illinois at ChicagoDaniel L. Kastner, MD, PhDScientific DirectorNational Human Genome ResearchInstituteStephen I. Katz, MD, PhDDirectorNational Institute of Arthritis andMusculoskeletal and Skin DiseasesCrystal Mackall, MDChief, Pediatric Oncology BranchHead, Immunology SectionNational Cancer InstitutePeter MarkellVice President of FinancePartners HealthCare System, Inc.Sharon O’Keefe, RN, MSNPresidentLoyola University HospitalMaryland Pao, MDClinical DirectorNational Institute of Mental HealthL. Reuven Pasternak, MD, MPH, MBACEO, Inova Fairfax Hospital CampusExecutiveVice President,Academic AffairsInova Health SystemSteven A. Rosenberg, MD, PhDChief, Surgery BranchNational Cancer InstituteNeal S.Young, MDChief, Clinical Hematology BranchNational Heart, Lung, and Blood InstituteEx Officio MembersJohn I. Gallin, MDDirectorClinical CenterNational Institutes of HealthMichael M. Gottesman, MDDeputy Director for Intramural ResearchNational Institutes of HealthH. Clifford Lane, MDChairMedical Executive CommitteeClinical DirectorNational Institute of Allergy and Infectious DiseasesExecutive SecretaryMaureen E. Gormley, RN, MPHChief Operating OfficerClinical CenterNational Institutes of HealthSenior Staff SupportRichard G.Wyatt, MDExecutive DirectorOffice of Intramural ResearchNational Institutes of Health*As of December 31, 2010There are two pending vacancies58 • ANNUAL REPORT 2011

MEDICAL EXECUTIVE COMMITTEE MEMBERS (2010)*NIH Clinical CenterThe Medical Executive Committee is made up of clinical directors of the NIH intramural clinical research programsand other senior medical and administrative staff.H. Clifford Lane, MD(Chair) National Institute ofAllergy and Infectious DiseasesMaryland Pao, MD(Vice Chair)National Institute of Mental HealthJames E. Balow, MDNational Institute of Diabetes andDigestive and Kidney DiseasesRichard O. Cannon, III, MDNational Heart, Lung, and Blood InstituteCarlo Contoreggi, MDNational Institute on Drug AbuseWilliam L. Dahut, MDNational Cancer InstituteJosephine M. Egan, MDNational Institute on Aging (Acting)Frederick L. Ferris, III, MDNational Eye InstituteMary Kay Floeter, MDNational Institute of NeurologicalDisorders and Stroke (Acting)William A. Gahl, MD, PhDNational Human Genome Research InstituteClare E. Hastings, PhD, RN, FAANNIH Clinical CenterMarkus Heilig, MD, PhDNational Institute on Alcohol Abuseand AlcoholismDavid K. Henderson, MDNIH Clinical CenterHenry Masur, MDNIH Clinical CenterJames E. Melvin, DDS, PhDNational Institute of Dental andCraniofacial ResearchDeborah P. Merke, MD, MSNIH Clinical CenterRobert Nussenblatt, MDNational Center for Complementaryand Alternative Medicine (Acting)Forbes D. Porter, MDNational Institute of Child Healthand Human Development (Acting)Steven A. Rosenberg, MDNational Cancer InstituteLeorey Saligan, PhD, RN, CRNPNational Institute of Nursing ResearchRichard M. Siegel, MD, PhDNational Institute of Arthritis andMusculoskeletal and Skin Diseases (Acting)Elad Sharon, MD, MPHClinical FellowNational Cancer InstituteCarterVan Waes, MD, PhDNational Institute on Deafness andOther Communication DisordersDarryl C. Zeldin, MDNational Institute of EnvironmentalHealth Sciences (Acting)Ex Officio MembersJohn I. Gallin, MDNIH Clinical CenterDaniel L. Kastner, MD, PhDDeputy Director for Intramural Clinical ResearchPatricia A. Kvochak, JDDeputy NIH Legal AdvisorRichard G.Wyatt,MDOffice of Intramural Research, NIHLaura M. Lee, RNNIH Clinical Center*As of December 31, 2010ANNUAL REPORT 2011 • 59

Assistant Director for Ethics andTechnology DevelopmentLisa Marunycz, RN, MBADIRECTORJohn I. Galin, MDChief Operating OfficerMaureen E. Gormley, MPH, RNDeputy Director for Educational Affairsand Strategic PartnershipsFrederick P. Ognibene, MDDiversity Management and Minority OutreachWalter Jones, MSChief OperatingOfficerMaureen E. Gormley,MPH, RNDeputy forAdministration/Office ofAdministrativeManagementLynda RayDeputy forOperations andWorkforceManagement/Office of WorkforceDevelopmentHillary J. Fitilis, JDNutritionDepartmentDavid Folio, MS, RDOffice of Purchasingand ContractsSydney JonesChief Nurse OfficerClare Hastings,PhD, RN, FAANDeputy ChiefAmbulatory CareServicesKaren Kaczorowski,MHSA, RNDeputy ChiefInpatient ServicesTannia Cartledge,MS, RNChief, Research& PracticeDevelopmentServiceGwenyth Wallen,PhD, RNChief FinancialOfficerMaria Joyce, MBAOffice of FinancialResourceManagementDaniel P. RinehulsOffice ofManagementAnalysis & ReportingMelissa B. Moore,MSW, MBAOffice of ProtocolServicesKim Jarema, RHIADepartment ofClinical ResearchInformatics andChief InformationOfficerJon W. McKeeby,DScBioethics DepartmentEzekiel Emanuel,MD, PhDLaboratoryfor InformaticsDevelopmentJames J. Cimino, MDRadiologyand ImagingSciencesDavid A. Bluemke,MD, PhD, MsBDeputy Director forClinical CareDavid K. Henderson,MDDepartment ofPerioperative MedicineActing, Julie Labovsky, MDDepartment of Laboratory MedicineThomas A. Fleisher, MDCritical Care MedicineDepartmentHenry Masur, MDPharmacy DepartmentRobert DeChristoforo,MSRehabilitationMedicineDepartmentLeighton Chan, MDMPHHousekeepingDepartmentRobert Mekelburg,MBADepartment ofTransfusionMedicineHarvey Klein, MDMaterialsManagementDepartmentFrancis LaBosco,MS, PDPositron EmissionTomographyDepartmentPeter Herscovitch,MDSocial WorkDepartmentAdrienne Farrar, PhDMedical RecordDepartmentPatricia Coffey, RHIASpiritual MinistryDepartmentJohn M. Pollack, MDiv,BCCOffice ofCredentialsServiciesJoseph Hendery,RHIAOffice ofCommunications,Patient Recruitment& Public LiaisonSara ByarsOffice of FacilityManagementDebra A. Byram,RN, MSNOffice of HospitalityServicesDenise Ford, MS, RDEdmond J. SafraFamily LodgeLawrence Eldridge,MSHAHospitalEpidemiology ServicesDavid K. Henderson, MDClinical Epidemiology &Biostatistics ServiceRobert Wesley, PhDPain and PalliativeCare ServiceAnn Berger, MSN, MDInternal MedicineConsult ServiceFred Gill, MDPediatric ConsultServiceDeborah Merke, MDVeterinary CareProgramLisa Portnoy, VMD60 • ANNUAL REPORT 2011

NATIONAL INSTITUTES OF HEALTHNational Cancer Institute (NCI)National Eye Institute (NEI)National Heart, Lung, and Blood Institute (NHLBI)National Human Genome Research Institute (NHGRI)National Institute on Aging (NIA)National Institute on Alcohol Abuse and Alcoholism(NIAAA)National Institute of Allergy and Infectious Diseases(NIAID)National Institute of Arthritis and Musculoskeletal andSkin Diseases (NIAMS)National Institute of Biomedical Imagingand Bioengineering (NIBIB)Eunice Kennedy Shriver National Institute ofChild Health and Human Development (NICHD)National Institute on Deafness and OtherCommunication Disorders (NIDCD)National Institute of Dental and CraniofacialResearch (NIDCR)National Institute of Diabetes and Digestive andKidney Diseases (NIDDK)National Institute on Drug Abuse (NIDA)National Institute of Environmental Health Sciences(NIEHS)National Institute of General Medical Sciences(NIGMS)National Institute of Mental Health (NIMH)National Institute of Neurological Disorders andStroke (NINDS)National Institute of Nursing Research (NINR)National Library of Medicine (NLM)Center for Information Technology (CIT)Center for Scientific Review (CSR)John E. Fogarty International Center (FIC)National Center for Complementary andAlternative Medicine (NCCAM)National Center for Minority Health andHealth Disparities (NCMHD)National Center for Research Resources (NCRR)NIH Clinical Center (CC)