The sickle cell anemia pilot is an outgrowth of collaborative research between several Institutes and departments. Shown here are (from left) CCMD's Dr. Mark Gladwin, Jim Nichols, R.N., Nursing; Dr. Alan Schechter, NIDDK; and Dr. Frederick Ognibene, CCMD.

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CC researchers visit the community

It seemed quite fitting that during the season of giving a roomful of people at Howard University were contemplating giving unarguably the most a person can ever give--of themselves to advance science.

The room was dressed with a holiday theme and filled with attendees ranging from babies to the elderly. All had at very least two things in common. For one, as members of the Parents Support Group for Children with Sickle Cell Disease, they all were affected in one way or another by sickle cell anemia, a painful and debilitating disease, which affects one in every 400 African Americans. And secondly, they all listened intently to the promising words of their guests, Dr. Mark Gladwin and Jim Nichols, R.N., with the CC Critical Care Medicine and Nursing Departments, respectively, as they discussed a new project.

The project, co-sponsored by the Critical Care Medicine Department (CCMD) of the CC and the NIDDK, has taken researchers out of their labs and into the local community to study a new treatment for the disease.

"This pilot provides a unique opportunity because there is clearly a need for more and better treatment options for people living with this debilitating disease," said Dr. Frederick Ognibene, senior investigator in the CCMD. "We have been lucky enough to find people in our community who want to see an end to this disease and have been caring enough to participate in our pilot project."

"This research initiative and outreach efforts demonstrate the Clinical Center's commitment to identifying and meeting the health needs of our community," said Dr. John I. Gallin, CC director.

"Clinical research is essential to the discovery of new knowledge that leads to better health for everyone," said Dr. Gallin.

Researchers from the Clinical Center and the NIH have visited local churches, hospitals, and support groups to talk with community members about the promising treatment and elicit participation in the study. In addition to Howard University, the group is also working with Children's National Medical Center, as well as organizations such as the Armstead-Barnhill Foundation, which serves the community by developing new medical research options for sickle cell anemia patients.

That Saturday afternoon presentation at Howard University not only gave the presenters an opportunity to explain the study, but more than an hour-and-a-half after the meeting began, questions on the latest research advances in the area were still being fielded by Dr. Gladwin. "It is very exciting to go out into the community and be accepted as we have been," said Dr. Gladwin. "Many people have been very supportive of our efforts and it is truly gratifying to see the response from community members excited to have an opportunity to participate."

Despite the name of the support group, they provide resources to more than just parents of sickle cell anemia patients, said Pauline Davis, president of the group. Their membership often includes siblings, friends, families, and patients themselves. Their goal is to educate those affected by the disease, and they often find presentations such as the one conducted by the CC representatives very useful to the group. "We try to educate ourselves about the disease and some of the newest treatments that can help our kids lead normal lives," said Davis.

More specifically, the treatment involved in the CC pilot is looking at the effects of nitric oxide on hemoglobin, which is the molecule in red blood cells that carries oxygen from the lungs throughout the body. Not to be confused with nitrous oxide, or laughing gas as it is commonly known, nitric oxide is a colorless, tasteless, and odorless gas that is the focus of this pilot.

"We have seen some pretty impressive early data and strong scientific support that indicate nitric oxide could be effective, " says Dr. Gladwin, the study's principal investigator. "It's an avenue of clinical research and treatment we want to explore."

The pilot, under the CC's leadership, is a collaboration among the NIDDK, NHLBI, and the NCI. "This has been a unique opportunity for our Institutes to work together as a team," said Dr. Ognibene. "It is inspiring to see so many Institutes investing in this project to advance our knowledge of the disease."

The CCMD plans to continue presenting to local community organizations regarding the pilot project. "Our goal is to continue to achieve a strong community presence so that when we are ready to move into a clinical research study of a specific treatment, we will have a strong patient base," said Dr. Ognibene.

-by LaTonya Kittles

About the study The Clinical Center pilot examines the effects of nitric oxide, a colorless, tasteless, and odorless gas, on hemoglobin. Hemoglobin is the molecule in red blood cells that takes oxygen from the lungs and carries it throughout the body. Red blood cells usually have a rounded shape. In sickle cell anemia, the cells become elongated and "sickled." Those irregularly shaped cells tend to clog arteries, which slows the flow of oxygen-rich blood throughout the body. That slowing of the blood flow causes the often-debilitating pain that sickle cell anemia patient's experience. At the heart of the Clinical Center study is this question: Can nitric oxide contribute to better blood flow that will decrease the pain? Time and more research will tell. For specific information concerning the pilot, contact Dr. Gladwin at 6-9320.

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New Year's wishes from the director

At midnight on Jan. 9, one door closes and another opens, signaling a new year of change for the Clinical Center. Closing is the Clinical Center's familiar front door on Center Drive. Beginning on Sunday, Jan. 10--and for the duration of construction for the Mark O. Hatfield Clinical Research Center--the Clinical Center's main entrance will shift to the south.

Consider that a signal, too, for a new year filled completely with challenge and opportunity. The plans and preparations for our new research center will begin to take shape over the next months and years. We'll all more fully see and feel the effects of construction. As we begin a new year, I'd like to outline some of the major accomplishments the Clinical Center has realized over the past 12 months.

 

Clinical Center programs

Creating efficiencies while expanding services and programs is never easy, but that's what the Clinical Center staff did during 1998. As a result, $3.1 million from our FY98 budget will be "carried over" for reinvestment in new programs under the FY2000 budget. The CC Advisory Council will evaluate proposals from the Institutes on how to use the money. Their recommendations will go to Dr. Harold Varmus, NIH director, for a final decision.

We initiated exciting new programs during 1998, including one in organ transplantation. This will be a joint effort with NIDDK, Walter Reed Army Medical Center, the Naval Medical Research Center, and the Diabetes Research Institute of the University of Miami. Trials in the transplantation of pancreatic islet cells and kidneys will test new treatments for patients with type 1 diabetes or kidney failure.

The NIMH clinical brain disorder research program, previously carried out at St. Elizabeth's Hospital in Washington, moved to the Clinical Center's 4 West patient-care unit early in 1998. That transition was a smooth one thanks to the splendid planning and coordination of all involved.

On Aug. 31, the Clinical Center's contract for anesthesia and surgical services with Georgetown University was brought in-house and a new Department of Anesthesia and Surgical Services created. Dr. Karen Williams, who had led the department while it was under contract, was named chief of the new department. Dr. Thomas Fleisher was chosen to lead the Clinical Pathology Department. Dr. Ezekiel Emanuel, an advisor to the CC Department of Clinical Bioethics for two years, joined our full-time staff. Other key appointments in 1998 included Dr. Fred Gill and nurse practitioner Laura Shay. This new team will provide consultation in internal medicine.

As 1998 ended, the Clinical Center held a Forum on Pain Management and Palliative Care to explore the best way to provide these services within our hospital.

 

Education

Educational opportunities in clinical research grew last year thanks to two new programs. The first is collaboration in long-distance learning with the School of Medicine at Duke University leading to a Master of Health Sciences in Clinical Research degree. The first class of 13 medical students and fellows was admitted in September. They join a Duke classroom through teleconferencing. The second new program is the post-doctoral Clinical Pharmacology Research Associate Program (ClinPRAT), which has drawn about 175 students to the program's "Principles of Clinical Pharmacology." A cooperative effort with the NIGMS, ClinPRAT will help prepare scientists to conduct both basic and applied clinical pharmacology research.

The popular "Introduction to the Principles and Practice of Clinical Research" continued in 1998. More than 1,100 students have completed the course since the program began as a pilot in 1995.

 

Governance

In February, Dr. Harold Varmus, NIH director, extended the Board of Governors charter until April 2000. Two new members joined the Board of Governors in 1998, Dr. Michael Johns and Dr. W. Marston Linehan. Dr. Johns is Executive Vice President for Health Affairs at Emory University and Chairman of the Board and CEO of Emory Healthcare. Dr. Linehan is chief of the Urologic Oncology Branch, NCI. Dr. H. Clifford Lane, NIAID clinical director, was named to complete the term of the late Dr. Jeffrey Hoeg. Dr. Hoeg, an extraordinary scientist, physician, and friend, died on July 21, 1998.

The Board continues to tackle major challenges. One initiative is a "school-tax" approach to Clinical Center funding. Developed and recommended by the Board in 1997, it was approved during 1998 by Institute and Center directors and Dr. Varmus. The initiative will provide a more predictable Clinical Center assessment to the Institutes and encourage full use of CC services.

The Board also initiated operational reviews for CC departments, beginning with the Materials Management and the Housekeeping and Fabric Care Departments.

The Clinical Center Advisory Council, established in 1997, continues to provide a strong voice and involvement for the Institutes in Clinical Center issues affecting intramural clinical research programs. A major contribution by the Council during the past 12 months has been planning for use of the new Clinical Research Center.

In 1998, the Clinical Center's Board of Scientific Counselors conducted its first review dedicated exclusively to science. Operational aspects of departmental performance are reviewed separately by the Board of Governors.

The Medical Executive Committee has also been busy in 1998, which began with the election of Dr. Scott Whitcup, NEI clinical director, to a two-year term as committee chair. A major action was revision of the physician-referral policy to allow patient self-referral.

In January, we asked Institute directors to nominate current and former patients for membership in a group to provide advice on design of the new Clinical Research Center. The Patient Advisory Group's role quickly evolved. They now meet quarterly, providing advice on and insight into patient concerns.

 

Alliances

In 1998, we continued our efforts to form alliances with our colleagues in health care and science. In February, we began a stroke and cardiac imaging project with Suburban Hospital, the NINDS, and NHLBI. In April, we joined with the National Rehabilitation Hospital to work with individuals with physical disability caused by illness and injury.

 

Communications and public outreach

We took major strides in identifying how the public views the Clinical Center and structuring new approaches to recruit patients. Working with Macro International, Inc., a professional services firm, and Porter Novelli, a public relations firm, we are developing a patient recruitment plan that includes physician mobilization, community outreach, public and professional awareness, and internal capacity building.

In July, Dr. Harold Varmus, NIH director, acted on a recommendation by the National Academy of Sciences' Institute of Medicine to make sure that the public had a strong voice in the work we do and ultimately improve the setting of research priorities. The Clinical Center joined all of NIH in designating an office for public liaison. The Patient Recruitment and Referral Center, now renamed the Office of Patient Recruitment and Public Liaison, will lead that effort.

The Clinical Center's successes are the successes of all who work here. As we begin 1999, remember that your enthusiasm, dedication, and creativity continue to be our greatest strengths.

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