past issues

Published monthly for CC employees by Clinical Center Communications March 2000 Dangerous liaisons Mock Joint Commission survey in April CC welcomes new rabbi Pharmacy deputy named NIH Moms Club CRC set to take off News briefs Studies

Dr. Stephen Piscitelli (left) and Dr. Aaron Burstein (right) discuss the results of their drug-interaction study involving St. John's wort. Dangerous liaisons CC pharmacists uncover drug interaction with St. John's wort If you're like many people, you take your morning vitamin tablet, and follow it with some sort of herbal remedy. Maybe a little gingko biloba? Some melatonin? How about a St. John's wort tablet? But how much do you really know about the effects and side effects of herbal compounds? Dr. Stephen Piscitelli wanted to know more. In collaboration with NIAID, he conducted a study of St. John's wort, and what he found is sounding a cautionary note for people who take herbal preparations. Dr. Piscitelli, coordinator of the Clinical Pharmacokinetics Research Laboratory of the Clinical Center's Pharmacy Department, and his colleagues found that St. John's wort significantly reduced the blood levels of a drug called indinavir, one of a class of drugs called protease inhibitors taken by many patients with HIV/AIDS. The main ingredient in St. John's wort, hypericin, is thought to speed up indinavir's metabolism. Consequently, not enough indinavir remains in the blood to do the job it's designed to do. "The low blood levels also can lead to drug resistance," said Dr. Piscitelli. The study, conducted among eight healthy volunteers, first measured the amount in the body of the drug indinavir when taken alone. Next, study participants were given only St. John's wort for two weeks. Finally, indinavir and St. John's wort were given together. "The results were dramatically conclusive," Piscitelli noted. "All the participants showed a marked drop in blood levels of indinavir after taking St. John's wort. The drop ranged from 49 percent to 99 percent." Researchers in Switzerland also published data indicating that St. John's wort reduced the blood levels of cyclosporine, a drug used after organ transplantation to prevent rejection. Dr. Piscitelli's findings, published in the Feb. 12 "Lancet," a British medical journal, generated a flurry of media attention last month. He granted interviews to over 15 news organizations, and appeared on "Good Morning America." Dr. Piscitelli's collaborative research between the CC and NIAID has focused on how antiretroviral and cytokine therapies are metabolized by the body, and evaluations of drug interactions. After learning of case reports, anecdotal evidence, and research data that all suggested a drug interaction with St. John's wort, he thought this study seemed a logical choice to pursue. "Depression is a common problem in the HIV-infected population, and St. John's wort has been used and studied for depression." A survey of the OP8 HIV clinic patients identified about 10 percent who had used St. John's wort. "There could be thousands of patients worldwide who are taking St. John's wort and antiretroviral drugs," he said. But users of complementary health practices often do not confide these facts to their physicians, he pointed out. "Patients may assume the doctor will have a negative reaction." There may be a basis for that reaction, however. Herbals are unregulated in this country. As a result, little hard science exists to support claims of either benefit or harm. "These compounds don't go through the rigorous testing that pharmaceuticals do, they don't have to prove safety or efficacy, and they are considered dietary supplements, not drugs, so they can bypass all the standard testing which prescription and over-the-counter drugs have to go through. So it's 'buyer beware,'" said Dr. Piscitelli. "There is a general misconception among the public that these herbal products have no adverse effects and no drug interactions. Our study clearly shows that there can be dangerous interactions between these products and other drugs," he said. Dr. Piscitelli urges health professionals to ask their patients what herbals they may be taking-and be open-minded to the response. Conversely, patients should provide this information even if they are not specifically asked. Dr. Piscitelli and his colleagues are currently looking at other widely used herbal preparations, including garlic, melatonin, gingko biloba, kava kava, and saw palmetto, to see if any similar drug interactions occur. "These are the most widely used of the herbal remedies and may have the greatest impact on public health. Also, there is existing evidence that these compounds may affect drug metabolism," he said. Other collaborators on the study included Dr. Aaron Burstein and Raul Alfaro from the Clinical Center Pharmacy Department, and Dr. Judith Falloon and Doreen Chaitt from NIAID. For more information on Dr. Piscitelli's upcoming studies, or to be considered for participation, contact the Clinical Research Volunteer Program at 1-800-892-3276. --by Sue Kendall But the label says.... The St. John's wort tablets Dr. Stephen Piscitelli used in his study were commercially prepared. The research team had the luxury of having the CC's own Pharmaceutical Development Service test the tablets to ensure that the contents were as stated on the label. And they were. But that is often not the case with herbal remedies. "Several studies have looked at various brands and found them to range in potencies," said Dr. Aaron Burstein, a collaborator on Dr. Piscitelli's study. Dr. Burstein pointed to a study commissioned by the "Los Angeles Times" in 1998, which tested the potency of 10 brands of St. John's wort. The potencies ranged from 20 percent to 140 percent of what was stated on the label. The recommended dosages on the label also differ, resulting in different intake for different products, Dr. Burstein pointed out. "The big problem with these compounds is that they are not regulated. They don't have manufacturing guidelines or quality controls like a pharmaceutical drug would need to have," said Dr. Piscitelli. He likens the herbal industry to Forrest Gump's proverbial box of chocolates: "You never know what you're going to get." --S. K. Back to Top

Mock Joint Commission survey in April

This fall, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will be visiting the Clinical Center to assess our operations. As a sort of dress rehearsal for the accreditation survey, an independent group, Safety Management Services, will come to the CC April 3-5 to conduct a mock survey. In the past, the Clinical Center has received high marks from JCAHO, and there is no reason to think this year will be any different. However, a little advance planning can ensure that things go smoothly. "We welcome the mock-survey team," said Dr. David K. Henderson, deputy director for clinical care. "It will provide us with a scorecard that will show us areas where we can improve. It makes good sense to do this." The survey team, which will consist of a doctor, a nurse, and an administrator, will meet with the Medical Executive Committee, the Department heads, the JCAHO workgroup, and other groups, and will perform checks of most units. Areas of scrutiny will include: performance improvement and measurement medication administration assessment of patients conscious sedation use of restraints confidentiality, informed consent, and patients' rights competencies patient and staff education emergency procedures, infection control, and safety issues According to Dr. Michele Evans, the CC's safety officer, the upcoming fall survey will differ in a major way from past surveys. "JCAHO isn't interested in formal presentations in meeting rooms anymore. They will be on the floors, observing patient care, checking for safe and sanitary conditions for workers and patients, and other activities. The mock survey will be good preparation for this change." Laura Lee, special assistant to the deputy director for clinical care, described a possible scenario: "The team could identify a nurse or a doctor to follow into a patient's room, observe the care being given, and then ask questions about why something was done. They may also ask questions about what patient education was done, and then confirm that with the patient." This extra level of detail means the team will spend more time on the units than in the past. Expect the visits to last at least an hour. "Our goal is for staff to be candid about any problems that may exist. There is plenty of time to correct any deficiencies. In my view, it is better to find out about problems now rather than be surprised in October," said Lee. After the mock survey, the group will issue its findings, pointing out areas where the Clinical Center performed well and areas where we can improve. Also part of the process is education on best practices-things that other institutions are doing that are worth emulating. If you have any questions or concerns about the mock survey, contact your departmental representative, or Dr. Evans at 6-5281, or Laura Lee at 6-8025. -by Sue Kendall   Back to Top

Pharmacy deputy named Capt. Robert De Christoforo

Capt. Robert DeChristoforo has been named deputy chief of the Clinical Center Pharmacy Department. In his 21 years with the Pharmacy Department, Capt. DeChristoforo has held such positions as clinical pharmacist and drug information officer. His deputy-chief duties include continued leadership of the Inpatient Pharmaceutical Care Section. He received his bachelor of science in pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences in Boston, and earned his master of science degree at Northeastern University in Boston. Capt. DeChristoforo completed a hospital pharmacy residency at the USPHS Hospital in San Francisco and received the USPHS Career Achievement Award in Pharmacy as well as the Hospital Pharmacist of the Year Award from the District of Columbia Society of Hospital Pharmacists (DCSHP). He is a contributing editor for the AIDS Facts column of the "American Journal of Health-System Pharmacy" and has been president of the DCSHP and the DC Metro Area branch of the Commissioned Officers Association. In 1998 he received the PHS Outstanding Service Medal for his efforts in HIV education and safe handling of hazardous drugs. Back to Top

Quality of Worklife

NIH Moms Club Did you know that NIH has a Moms Club composed of NIH staff who are mothers? The group was formed almost five years ago to share information, as well as provide support mechanisms. All interested staff are invited to get together on the first Tuesday of every month at noon in the Bethesda Room, which is part of the B1-level cafeteria. There is open membership, so feel free to come whenever you can. Members of the group hope to have regularly scheduled guest speakers to discuss topics of interest, including what to do when your baby has a fever, how to creatively arrange day care, and lactation issues at NIH. One of the major areas of interest for the group was seeing a lactation program at the NIH. There are now onsite lactation rooms in Bldgs. 31 (Room B2B39), 10 (Room 6C426, next to OMS), 45 (Room 6AN16), 49 (Room 1A63), and the Neuroscience Research Center at 6001 Executive Blvd. (Room 111). For more information on the lactation program, visit http://odp.od.nih.gov/whpp/events/lactation.html, or call 5-7850. For more information on the Moms group please visit their web site at http://www.recgov.org/moms/. This information was brought to you by the CC Quality of Worklife Council. Back to Top

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CRC set to take off Rapid progress is occurring on the new Clinical Research Center (CRC), according to Don Sebastian, of the Division of Engineering Services. "The first phase of construction is complete, which includes the building's foundation-the concrete slab, support columns, and walls. Underground utility lines have also been placed. Now people will start to see things happen rapidly," he said. A fourth tower crane has been erected. With all cranes functional, materials can be moved to 90 percent of the construction site. Baker Concrete has been contracted to complete the remaining concrete work. Baker has erected a concrete plant on site (left), which can deliver up to 200 cubic yards of concrete per hour, made to CRC specifications. The plant has a quality-control system to monitor the concrete's strength. Interested in keeping up with CRC construction? Monthly status reports will be posted to this web site: http://www.cc.nih.gov/ccc/crcnews/updates.html Back to Top

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News briefs Classes offered Call the Education and Training Section of OHRM at 6-1618 to register for the following classes: "Really Effective Scientific and Technical Presentations," March 22 and 23, from 9 a.m. to 4 p.m. During this 2-day class, presenter Richard C. Oliver, M.S., will teach techniques for delivering papers at professional meetings or presenting data to small or large groups of scientific peers or nonprofessionals. You will also learn how to design a PowerPoint presentation and use it skillfully and smoothly. You will have the opportunity to make a brief videotaped presentation for immediate feedback from peers and the instructor. "Management Essentials," April 5, from 9 a.m. to 4 p.m. Presenter Rosalind Jeffries, M.A., will help you develop a sample management plan, decide how to put your plan in action, evaluate the needs of your employees, learn how to implement change, and manage conflict constructively. Skills necessary to become effective managers and leaders will be explored. "Macintosh Computer Training," April 17, Excel; April 18 or 21, Microsoft Word; April 19, FileMaker Pro; April 20, PowerPoint. Have your Departmental Contact call to register you for Macintosh training. Space is limited. All classes are held at 6100 Executive Blvd., Room 3E01. The building is shuttle-bus accessible. Visitor parking is $6 per day. Blood shortage The Department of Transfusion Medicine is in critical need of type O blood. Several recent surgical procedures have significantly depleted our inventory of this type of blood. If your blood type is O, please donate by visiting the Blood Bank, Bldg. 10, Room 1C713B, or call 6-1048. We need your help to continue to supply blood to our patients. Management interns The NIH Management Intern Program is accepting applications until March 14. This 12-month career development program will accept up to 5 participants for positions at the GS-5, GS-7, and GS-9 levels. Employees above the GS-9 level must accept a downgrade but may retain their previous salary levels. Interns receive training in a variety of administrative fields. Graduates are eligible for non-competitive promotion to the GS-12 level. Apply on-line at http://internships.info.nih.gov. For details, call the NIH Intern Coordinator at 6-2403 (press 7 to leave a message). Parking renewals NIH general parking permits for campus employees whose last names begin with E, F, or G will expire on the last day of March. To renew yours, visit the NIH Parking Office in Bldg. 31, Room B3B04, weekdays between 7:30 a.m. and 4:30 p.m. Be sure to bring your valid NIH identification card, driver's license, and valid vehicle registration certificate for each vehicle to be registered. Training conference The 2000 National Training Conference on Employment of Federal Employees Who are Deaf or Hard of Hearing will be held on March 7, 8, and 9, at the Natcher Conference Center. All are welcome to attend. Registration is $50 prior to the conference; if registering on-site, the cost will be $75. For details, check the web site, http://www.dhhig.org/ntc/, or contact Lori Ingram at TTY: 2-1562, or Federal Relay Service, 1-800-735-2258 (Voice/TTY), or e-mail: Lori_Ingram@nih.gov. Garage finished The concrete restoration in the CC garage is complete. Cleanup should be finished by March 15, and most of the parking spaces should be back in use, according to project officer Buck Lewis. A renovation effort will soon begin, including fresh paint, parking stripes, brighter lighting, and new signs. But Lewis says that work will be done after hours to minimize disruption. Construction of the new Clinical Research Center will also continue to cause temporary disruptions and loss of parking spaces from time to time. Gallery change The exhibit in Gallery I changes the first of this month. The featured artist is Sean Callahan, a watercolorist and CC patient. The exhibit runs through May 3. Gallery I is located on the first floor of the Clinical Center, near the coffee shop and flower shop.   Back to Top

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Studies Twin study Healthy, adult, identical-twin pairs are needed for a study of the differences in the genotype and phenotype of the T-cell receptor. Study procedures include a thorough medical history, HLA testing, complete blood count, and leukapheresis. Participants should be available for further questioning about their medical histories. Participants will be paid for their blood donations. If you have responded to this inquiry in the past, please resubmit your name and phone number for another phase of the study. Call the HLA Laboratory at 6-8852 for details. Sickle cell study NIDDK researchers are conducting a study to better understand sickle cell anemia. Healthy adult volunteers with sickle cell trait are needed. The study involves blood draws, injections of granuloctye-colony stimulating factor, and a leukapheresis procedure. Volunteers will be financially compensated if they are selected for the study. For details, call 1-800-411-1222 or 2-3087. Healthy mothers NIMH researchers seek right-handed mothers aged 20 to 40 with non-adopted, first-born children aged 5 to 12 to participate in an fMRI study on the visual processing of faces. Volunteers should have no history of medical or psychiatric disorders, and should not be taking prescription medication (including birth control pills). The first-born children of volunteers should have no history of psychiatric illness or chronic medical problems. Volunteers must have normal vision or wear contacts. Participation requires a 2-hour screening interview, a follow-up visit, and a 3-hour visit for the fMRI scan. Participants will be reimbursed. For more information, call Lisa Kalik or Neil Santiago at 6-8381. Endometriosis study NICHD researchers invite women with pelvic pain associated with endometriosis to take part in a new treatment study. Call the Patient Recruitment and Public Liaison Office for more information at 1-800-411-1222. Visual study NIMH researchers seek men aged 56 to 73 and women aged 51 to 59, to participate in an fMRI study on the visual processing of faces. Partici-pants must be right-handed and currently married. Volunteers should have no history of medical or psychiatric disorders, and should not be taking prescription medication (except hormone replacement therapy for women). Volunteers must have normal vision or wear contact lenses. Participation requires a 2-hour screening interview, a follow-up visit, and a 3-hour visit for the fMRI scan. Participants will be reimbursed. For more information, call Lisa Kalik or Neil Santiago at 6-8381. Overweight teen? Parents, consider enrolling your teen in an NICHD study of a promising weight-loss medication. The Food and Drug Administration has approved the study drug, Orlistat, for use with adults. This study takes place at the Clinical Center. NICHD provides all study tests, medication, and weight-control education at no charge. Overweight teens, aged 12 to 17, who can attend weekly weight-control meetings may be eligible. Call the Patient Recruitment and Public Liaison Office for more information at 1-800-411-1222. Uveitis study NEI seeks adults and children with uveitis for research studies to help find ways to improve diagnosis and treatment. Participants receive study-related eye exams, testing, and care at no charge. For more information, call the Patient Recruitment and Public Liaison Office at 1-800-411-1222. Back to Top

Editor: Sue Kendall   Clinical Center News, 6100 Executive Blvd., Suite 3C01, MSC 7511, National Institutes of Health, 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. Deadline for submissions is the second Monday of each month. top | cc home page | nih home page |