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Clinical Center News

Published monthly for CC employees by Clinical Center Communications

past issues

December 2003


Training programs expand through long-distance learning

University of Pittsburgh Training in Clinical Research Program

NIH-Duke Training Program in Clinical Research

Studies

Bioethics course in sixth year

CRIS town hall meetings scheduled

Chief of Nursing elected as American Academy of Nursing fellow

Bishop named distinguished clinical teacher of the year

Folio new Chief of Clinical Center Nutrition Department

NIH scientists show nitrite improves blood flow

Avoiding the trap of holiday debt

December calendar


Governor Ehrlich visits Clinical Center

Governor Ehrlich visits Clinical Center
Left to right: Gov. Ehrlich, Clinical Center Director Dr. John Gallin, Dr. Barbara Alving, acting director, NHLBI, Dr. Betsy Nable, clinical director, NHLBI, and Dr. Raynard Kington, deputy director, NIH

Maryland Governor Robert Ehrlich visited the Clinical Center last month as part of a joint collaboration, focusing on cardiothoracic surgery and cardiology programs, between the National Institutes of Health (NIH), the National Heart, Lung and Blood Institute (NHLBI), and Suburban Hospital.

Governor Ehrlich, pictured here with Clinical Center Director Dr. John Gallin; Dr. Barbara Alving, acting director, NHLBI; Dr. Betsy Nable, clinical director, NHLBI; and Dr. Raynard Kington, deputy director, NIH, visited the cardio-intervention suite, a room currently under construction that will house both the CT scan and the Interventional/Angio. The design will serve as a test site and will allow patients to receive both tests without being transferred from one room to another.

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Training programs expand through long-distance learning

The NIH Clinical Center has extended its clinical research training programs to reach more than 1,000 physicians and other health professionals this year, in locations as far away as Peru and Puerto Rico.

"Proper training of clinical researchers is critical to advancing medical science," said Dr. John I. Gallin, Clinical Center director. "In the past, researchers have relied on mentors to teach them how to conduct clinical trials. We have established a formalized training program to fill this critical gap and we're extending it world wide." Improving clinical research training is a major initiative of the NIH road map, introduced by NIH Director Dr. Elias Zerhouni last month.

This year 1,426 students are enrolled in three core courses, "Introduction to the Principles and Practice of Clinical Research," "Principles of Clinical Pharmacology," and "Ethical and Regulatory Aspects of Clinical Research." They are available not only to NIH researchers, but are transmitted by satellite or web videocast to remote locations.

Established in 1995 at the NIH Clinical Center, the "Introduction to the Principles and Practice of Clinical Research" course is a study curriculum on how to effectively conduct clinical research and design a successful clinical trial. The current session is transmitted to nine offsite centers worldwide and has 653 registrants, more than half of them (360) are offsite. Since the course was established in 1995 with 25 students, it has trained more than 3,000 health professionals, nearly 1,000 of them in offsite locations.

The program has also expanded its diversity outreach. This year the course includes 69 registrants at Meharry Medical College in Nashville, 11 students at Morehouse School of Medicine in Atlanta, and 60 students at the University of Puerto Rico in San Juan.

Other locations participating this year are the Children's National Medical Center, George Washington University Medical Center and Georgetown University Medical Center in Washington, D.C., the State University of New York in Syracuse, the University of Texas Southwestern Medical Center in Dallas, and the U.S. Naval Medical Research Center Detachment in Lima, Peru. The current session began Oct. 20, 2003 and will run through Feb. 24, 2004.

"Clinical research training programs improve the skills of all clinical research teams and bring more patients into clinical trials," said Gallin.

"Principles of Clinical Pharmacology," offers training in the scientific basis of clinical pharmacology. Established in 1998 and led by Dr. Arthur Atkinson, the course is designed to meet the needs of researchers who have an interest in the clinical pharmacologic aspects of contemporary drug development and use. This year the program has 273 registrants (66 in remote locations). To date, it has enrolled 1,574 students, 202 have taken the training at off-site locations.

"Ethical and Regulatory Aspects of Clinical Research," is led by Drs. Ezekiel Emanuel and Christine Grady, of the Clinical Center Department of Bioethics. This seven-week course is currently in its sixth year and has 535 students registered this fall. Small groups of registrants are participating by internet. Additionally, a small number of fellows at the Western IRB in Olympia, Washington are attending the course by satellite and internet. A textbook, "Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary," has been published for the course by Johns Hopkins University Press.

Complementing these programs are two formal Clinical Center partnerships, one with Duke University and the other with the University of Pittsburgh, which lead to master's degrees in clinical research.

Additional information on these courses can be obtained from the Clinical Center Office of Clinical Research Training and Medical Education (Director, Frederick P. Ognibene, M.D. and Deputy Director, DeNedra McPherson) at 301-496-9425.

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NIH-Duke
Training Program in Clinical Research

Applications for the 2004-2005 NIH-Duke Training Program in Clinical Research are available in the NIH Clinical Center, Office of Clinical Research Training and Medical Education, Building 10, Room B1L403.

The NIH-Duke Training Program in Clinical Research, implemented in 1998, is designed primarily for physicians and dentists who desire formal training in the quantitative and methodological principles of clinical research. The program, offered via videoconference at the Clinical Center, offers formal courses in research design, research management and statistical analysis.

Academic credit earned by participating in this program may be applied toward satisfying the degree requirement for a Master of Health Sciences in Clinical Research from Duke University School of Medicine.

E-mail queries regarding the program may be addressed to tpcr@mc.duke.edu. The deadline for applying is March 1, 2004. Applicants who have been accepted into the program will be notified by July 1, 2004.

University of Pittsburgh
Training in Clinical Research Program

Applications for the 2004-2005 University of Pittsburgh Training in Clinical Research Program are available in the NIH Clinical Center, Office of Clinical Research Training and Medical Education, Building 10, Room B1L403.

The program, designed for Ph.D. and allied health professionals (e.g. pharmacists and nurses), consists of an integrated core curriculum taught over three semesters starting with an intensive eight-week summer session. The program has been modified so that NIH trainees are required to spend the first five days of the summer session in residence at the University of Pittsburgh. Physicians and dentists are also eligible to matriculate in this program.

Participants have the option of receiving a Certificate in Clinical Research (15 credits) or a Master of Science in Clinical Research (30 credits) from the University of Pittsburgh School of Medicine.

For more information, send an e-mail to tcrp@pitt.edu. The deadline for applying is March 1, 2004. Successful applicants will be notified by May 29, 2004.

Enrollment in this program is limited. Prospective participants should consult with their NIH institute or center regarding the official training nomination procedure.

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Studies

Depression study
The National Institute of Mental of Health seeks volunteers over the age of 18 to participate in a clinical trial exploring the research effects of medications compared to placebo for the treatment of depression and bipolar disorder. If interested please call 301-496-5645 (TTY 1-866-411-1010).

Wellbutrin study
Individuals being treated with a widely used antidepressant agent called wellbutrin are needed to participate in a study. Participants will be asked to donate four tablespoons of blood for routine screening and evaluation of platelet function. The visit will be no longer than one hour and compensation is provided. If interested or you have questions, please call Donna Jo McCloskey at 301-496-5150.

Apheresis study
The National Institute of Allergy and Infectious Diseases seeks Normal volunteers, ages 20 - 60, for an apheresis research study. Volunteers will receive an FDA approved drug designed to increase the white blood cell count and then participate in apheresis (a blood donation) to collect the excess cells. Compensation provided. Call Mary Huber, RN at 301-496-7935.

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Bioethics course in sixth year

Michael Gottesman
Michael Gottesman

Dr. Michael Gottesman, Deputy Director for Intramural Research, NIH introduces the "Ethical and Regulatory Aspects of Human Subjects Research" course on October 29. The course, now in its sixth year, covers the history and current status of human subject research and has increasingly grown in popularity-going from a first year of 120 registered students to more than 530 in 2003.

This year for the first time a new textbook, "Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary," published by The Johns Hopkins University Press, is being used. The editors are Ezekiel Emanuel, John Arras, Robert Crouch, Jonathan Moreno, and Christine Grady. The course, open to the NIH community-at-large and other interested parties, is offered each fall for seven weeks at the Clinical Center and web cast at www.videocast.nih.gov.

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CRIS town hall meetings scheduled

Bring your questions about CRIS, the NIH Clinical Research Information System project, to monthly town hall meetings that begin 12 -1 p.m. on Thursday, Dec. 4, and continue through August 2004. All sessions will be held in the Lipsett Amphitheater.

Please mark your calendars for upcoming sessions in 2004:

CRIS logo

Wednesday, January 7, (2-p.m.)
Thursday, February 5 (12 -1 p.m.)
Thursday, March 4 (12 -1 p.m.)
Thursday, April 1 (12 -1 p.m.)
Thursday, May 6 (12 -1 p.m.)
Thursday, June 3 (12 -1 p.m.)
Thursday, July 1 (12 -1 p.m.)
Thursday, August 5 (12 -1 p.m.)

For more information about the upcoming CRIS town meetings or to submit a question you would like to have answered during the sessions, send an email to cc-cris@mail.cc.nih.gov. For more information on CRIS visit http://cris.cc.nih.gov.

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Chief of Nursing elected as American Academy of Nursing fellow

Hastings
Clare Hastings

Each year the American Academy of Nursing inducts a limited number of distinguished leaders as Academy Fellows. The 2003 nominees were welcomed as new fellows at the Academy’s mid-November annual meeting in California and Clinical Center Nursing and Patient Care Services Chief Clare Hastings, Ph.D., R.N., FAAN, was among them.

She joins an elite group. According to the National Center for Health Workforce Analysis there are nearly 2.7 million nurses in the United States. Of those just over 1,500 are Fellows. They are the ‘brain trust’ of professional nursing and are recognized nationally and internationally as nursing leaders in education, management, practice, and research.

Distinction as an Academy Fellow is even more remarkable for clinical nursing leaders such as Dr. Hastings as it is most often given to nursing professionals in the academic world. As a clinical nursing executive she is recognized for advancing the role of nurses in ambulatory care at the national level; defining professional and career advancement pathways for nurses that have had a demonstrated effect on retention and job satisfaction; and improving quality of care by applying new strategies for outcomes assessment in the clinical setting.

A peer-nomination process identifies the Academy Fellows. Recognition by one’s peers as having made outstanding contributions to nursing over and above those that are required in one’s position of employment is a major part of the criterion.

Reflecting on her support of Dr. Hastings, Sheila Haas, Ph.D., R.N., FAAN, Professor and Dean, Niehoff School of Nursing of Loyola University Chicago stated, “There is a great need for astute and articulate nurse executives to speak about the real concerns in the U.S. healthcare system. Too often their insights are lost in the day-to-day demands of their roles. Dr. Hastings brings this perspective to the Academy. She has an unusual ability to conceptualize complex issues and use creative ways to make them very clear at a level that clinicians can understand. She continues to be one of only a few nurses who truly understand the issues of nursing intensity in ambulatory care. She also has a solid background in research methods and a real skill at conducting studies in the clinical setting and linking results to practical problems in the workplace.”

As chief nurse officer and a member of the executive team, Dr. Hastings directs patient care services that support the intramural research activities conducted by NIH at the Clinical Center. Prior to assuming these duties in October 2000 she served as the administrative director for medicine, Psychiatry, Women’s Services & Ambulatory Care Nursing at the Washington Hospital Center in Washington, D.C.; director, Quality Planning & Professional Development, Department of Nursing at the University of Maryland Medical System in Baltimore; and in a variety of nursing roles at the NIH Clinical Center. Among other honors and awards she has received the 2002 Chief Nurse Officer Award for Outstanding Contributions to Nursing, U.S. Public Health Service. Dr. Hastings’ research and evaluation activities include a variety of evaluation and outcomes analysis projects and institutional review board-approved research projects. She has more than a hundred publications and presentations to her credit and holds a doctoral degree in nursing from the University of Maryland and a master of science in nursing administration from Georgetown University.

She considers the American Academy of Nursing Fellow election to be especially meaningful because it recognizes achievements that go well beyond the usual sphere of a work role, and that influence the broader world of nursing and health care. “I have always hoped to have some sort of positive influence that would extend beyond the immediate world of work. It is wonderful to have an indication that this is the case. Election to the Academy gives me access to a special group of colleagues who are the national leaders in nursing. I believe we at the Clinical Center have contributions to make to the national agenda for improving health, and this will be a great resource and opportunity,” she said.

Her colleagues agree Dr. Hastings is well deserving of the Academy honor.

Carol Romano, Ph.D., R.N., FAAN, deputy chief of the Clinical Research Informatics Department, Clinical Center was at the 2003 FAAN induction ceremony and has provided support throughout the nomination process. She lauded Dr. Hastings, “Over time she has blazed pathways and directions for nurses to advance their professional contributions. She has demonstrated commitment to bridging the gap between practices, education and research. Her endeavors have greatly contributed to the development of nurse researchers.”

Clinical Center Director Dr. John Gallin concurs, “She has done an outstanding job integrating the Clinical Center’s nursing community with the clinical research objectives of the NIH institutes. Her innovative approaches are special. Dr. Hastings’ election to the Academy of Nursing illustrates the high esteem her peers have for her. It is a wonderful tribute to the Nursing Department at the Clinical Center.”

And the Clinical Center voice will certainly be heard as Dr. Hastings continues to help shape the future of nursing.

The American Academy of Nursing was established in 1973 under the aegis of the American Nurses Association. It provides visionary leadership to the nursing profession and the public in shaping future health policy, advancing scientific knowledge and influencing the development of effective healthcare policies and practices. http://www.nursingworld.org/aan/

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Bishop named distinguished clinical teacher of the year

Dr. Michael Bishop
Clinical Center Director Dr. John Gallin (left) and Distinguished Clinical Teacher Award subcommittee chairperson Dr Melinda Merchant (right) presented Dr. Bishop with the award.

Dr. Michael Bishop has been awarded the 2003 Distinguished Clinical Teacher’s Award for his outstanding guidance as a mentor in the professional development of clinical fellows.

“From a fellow’s point of view, a distinguished clinical teacher is a mentor who models the characteristics of an ethical and compassionate physician; he guides professional growth by helping us identify and develop skills, and assists us in prioritizing and achieving goals while anticipating and overcoming obstacles,” said Dr. Melinda Merchant, Senior Clinical Fellow in the Pediatric Oncology Branch, NCI, and subcommittee chairperson for the award.

Dr. Bishop serves as the clinical head, Experimental Transplantation and Immunology Branch, National Cancer Institute, where his research focuses on using stem cell transplantation on a variety of malignant disorders such as leukemias and lymphomas, as well as a number of other diseases such as breast cancer.

Prior to coming to NIH, Dr. Bishop worked as an Associate Professor of Medicine in oncology/hematology at the University of Nebraska Medical Center. In 1999, Dr. Bishop joined the National Cancer Institute as an investigator, later becoming clinical head of the Experimental Transplantation and Immunology Branch.

“Dr. Bishop's advice and example has helped me tremendously in terms of discussing treatment decisions with patients,” said Dr. Robert Dean, a clinical fellow who submitted a nomination on Dr. Bishop’s behalf. “More than other therapies, stem cell transplantation poses uniquely challenging risk/benefit assessments for both clinicians and patients. Dr. Bishop excels in his ability to grasp the fundamental issues in these situations, and to convey them both to other clinicians and to patients."

Born in Eldorado, Illinois, Dr. Bishop earned his M.D. from the University of Illinois Chicago College of Medicine. Concentrating on the dual disciplines of hematology and oncology, he completed his internship and residency in medicine at Northwestern Memorial Hospital in Chicago and his fellowship in hematology/oncology at Loyola University Medical Center, Maywood, Ill.

Being awarded the Distinguished Clinical Teacher’s Award adds to Dr. Bishop’s list of teaching honors, which includes the Top Teacher in Internal Medicine at the University of Nebraska Medical Center Award, 1996, 1997 and 1998. He was also listed in the national edition of The Best Doctors in America for 2001 and 2002.

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Folio new Chief of Clinical Center Nutrition Department

David Folio
David Folio

David Folio joined the Clinical Center staff last month as the new chief of the Nutrition Department.

“I’m finding this position to be fun and exciting,” said Folio. “I’m excited about getting to know the staff and having a support system that embraces out-of-the-box thinking and change.”

Folio said he hopes to continue the path set by former chief Alberta Bourn by stressing customer service, patient satisfaction and employee satisfaction. But he also plans on bringing new approaches and ideas to the department as it evolves along with the Clinical Research Center.

“I would like to foster team approaches, and with this I hope to be more in concert with other departments within the Clinical Center,” said Folio. “The food and nutrition field is constantly changing, and this department needs to be fluid and flexible in order to meet the needs of this hospital.”

Folio came to the Clinical Center from Wood Dining Services/Sedexho, USA, where he served as general manager of Food and Nutrition Services at Holy Cross Hospital in Silver Spring. Prior to that, he worked as director of Food Service at both Brandywine Hospital and Trauma Center in Brandywine, Penn., and Lancaster General Hospital and Trauma Center in Lancaster, Penn. He spent 3 years at Monmouth Medical Center in New Jersey managing clinical nutrition, management information services and training.

Folio received his Masters Degree in clinical nutrition from the University of Medicine and Dentistry of New Jersey and a Bachelors Degree in nutritional science from Rutgers University.

Folio’s accomplishments include implementing a spoken menu concept, creating financially strong nutrition services, significantly improving patient and employee satisfaction and improving safety while serving as district safety coordinator for Sodexho. He has received numerous awards from Wood Dining Services for leadership and quality, and he was published in the Journal of the American Dietetic Association last year for his original research on the spoken menu concept.

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NIH scientists show nitrite improves blood flow

Scientific Seminar to be held Dec. 12

The Office of Cancer Genomics, National Cancer Institute, is sponsoring a scientific seminar by Stuart L. Schreiber, Ph.D., director of the Initiative for Chemical Genetics, Harvard University, entitled "New Tools in the Fight Against Cancer: Small Molecules, Diversity-oriented Synthesis, and ChemBank." The seminar will be held on Friday, December 12, 2003 from 11:00 a.m. to noon in Masur Auditorium, Building 10.

The lecture will be videocast at http://videocast.nih.gov. For more information, or for reasonable accommodations, contact LaTonya Kittles at 301-451-6055 or the Federal Relay at 1-800-877-8339.

Clinical Center researchers have determined that nitrite, a salt in the blood, can improve blood flow and increase oxygen in the blood. This makes it a potentially new treatment for diseases such as high blood pressure, heart attacks, sickle cell disease, and leg vascular problems.

The study also describes a newly discovered function for the hemoglobin molecule itself; perhaps the most studied protein in human history. The new study demonstrates that when hemoglobin releases its oxygen in regions of the body with low oxygen (such as organs) or high metabolism, it can then convert nitrite to nitric oxide, which is known to dilate blood vessels. The article will be published in the December issue of Nature Medicine and was published online November 2.

"The importance of this work is that no one considered this molecule to have any significant function and it is relatively abundant in the blood stream," said Dr. Mark Gladwin, senior investigator in the CC Critical Care Medicine Department and an author of the article. Nitrite levels have been shown to be low in patients with high blood pressure.

Gladwin and coauthor Dr. Richard Cannon, Cardiovascular Branch, NHLBI, studied eighteen healthy volunteers who were enrolled in a physiological study. They were infused with sodium nitrite to determine whether nitrite affects blood flow. They showed that blood flow increased by 175 percent.

"We saw a huge improvement in blood flow," said Gladwin. "Nitrite helps get more blood to regions of the body with low oxygen, such as kidneys, the heart, the brain and muscles. This has potential as a new therapy that was previously overlooked," said Gladwin. "It's a powder sitting on the shelf and everyone has it." However, he warns that at high concentrations it can be toxic and clinical trials, now in progress at NIH, are required to establish its clinical usefulness in various diseases.

Nitrite is present not only in blood, but in leafy green vegetables and hot dogs. A similar reaction of nitrite and myoglobin in red meat makes nitric oxide bind to myoglobin and explains the red color of meat on grocery store shelves. Further study will be needed to determine if dietary sources of nitrite affect blood flow and blood pressure.

Scientists from NIDDK, the University of Alabama at Birmingham, and Wake Forest University, Winston-Salem, North Carolina also participated in this study.

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Avoiding the trap of holiday debt

Americans charged more than $100 billion between Thanksgiving and Christmas according to a Maryland-based consumer credit card information company. This means that despite the wonderful holiday that was spent with family and friends, many individuals will face financial crises when the bills arrive in the mail. Employee work life can be adversely impacted by financial worries. The coping tips below may help ease this burden:

  • Develop a budget: Realistically assess how much money comes in, and how much is spent. List all expenses and decide which ones can be eliminated.


  • Start a payment schedule: Pay the most on the card with the highest interest rate.


  • Put away your cards: Don't carry them around with you. You will only be tempted to use them.


  • If you are disciplined and can pay more than the minimum amount due, go for introductory rates to take advantage of lower interest rates.


  • Start a savings plan for next year so you won't spend what you don't have.


  • Call creditors: Explain the situation and work to develop a plan. Don't wait until the account has been turned over to a debt collector.


  • Credit counseling: Credit counseling services are available to help people create and stick to a workable budget, or assist in working out a repayment plan with creditors. Creditors may be willing to accept reduced payments from individuals participating in a debt-repayment plan with a reputable organization.


  • Debt consolidation: You may be able to lower the cost of credit by consolidating debt through a second mortgage or a home equity line of credit. These loans can be expensive, but may also provide certain tax advantages.


  • Bankruptcy: Personal bankruptcy is a last-resort option, which is far-reaching and long-lasting. It stays on a person's credit report for 10 years, making it difficult to acquire credit. However, if the rules are followed, a court order may possibly be obtained to release one from repaying certain debts.

Portions of this article were abstracted from the Federal Trade Commission publication, "Knee-Deep in Debt." Copies may be obtained from the FTC website at http://www.ftc.gov/bcp/conline/pubs/credit/kneedeep.htm.

December Calendar

3
Grand Rounds
12-1 p.m.
Ethics Grand Rounds

Who Owns NIH Data?
Stephen Rosenfeld, M.D., M.B.A., Chief, Department of Clinical Research Informatics, CC/DCRI and Clinical Research Information System Project Manager, Case Presenter
Rebecca Eisenberg, J.D., Robert and Barbara Luciano Professor of Law, The University of Michigan Law School, Ann Arbor, Michigan, Discussant

10
Grand Rounds
12 noon - 1 p.m.
Contemporary Clinical Medicine: Great Teachers

A Near Fatal Emission: Notes of a Medical Detective Thomas Duffy, M.D., Professor of Internal Medicine, Section of Hematology, Yale University School of Medicine

17
Grand Rounds
12 noon - 1 p.m.
50th Anniversary Celebration of Clinical Research

Endothelial Progenitor Cells in Cardiovascular Health and Disease
Toren Finkel, M.D., Ph.D., Chief, Cardiovascular Branch, NHLBI

Cytokine Mobilization of Stem and Progenitor Cells as Therapy for Ischemic Heart Disease
Richard Cannon, M.D., Clinical Director, NHLBI; Head, Clinical Cardiology Section, Cardiovascular Branch, NHLBI

Fluoroscopic MRI for Targeted Stem Cell Delivery to Myocardial Infarct Borders
Robert Lederman, M.D., Investigator, Cardiovascular Branch, NHLBI

24
No Grand Rounds
Holiday

31
No Grand Rounds
Holiday

Lectures can be accessed on the NIH Videocast at http://videocast.nih.gov

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Editor: Tanya C. Brown
Contributing writers: Dianne Needham, John Iler, Colleen Henrichsen
 

Clinical Center News, National Institutes of Health, 6100 Executive Blvd., Suite 3C01, Bethesda, MD 20892-7511. Tel: 301-496-2563. Fax: 301-402-2984. Published monthly for CC employees by the Office of Clinical Center Communications, Colleen Henrichsen, chief. News, article ideas, calendar events, letters, and photographs are welcome.

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