4-Day Onsite Briefing Is Chock Full|
HHS Secretary Gets to Know NIH from the Inside
By Carla Garnett
Photos by Bill Branson
On the Front Page...
HHS Secretary Tommy G. Thompson spent 4 fully packed days Aug. 20-23 on campus getting to know NIH from the inside out. From all appearances, he was impressed with everything he saw, greeting and offering encouraging words to each employee he encountered.
The working visit began at 8:45 Monday morning, when Thompson arrived with several staff members for a brief campus orientation by NIH acting director Dr. Ruth Kirschstein, acting deputy director Dr. Yvonne Maddox, deputy director for extramural research Dr. Wendy Baldwin and deputy director for intramural research Dr. Michael Gottesman.
Thompson announced shortly after his confirmation as Secretary that he would be making his rounds to the various HHS agencies for working visits that could last up to a week per agency. His first visit was in April to the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration) in Baltimore. Months ago Kirschstein, other NIH senior staff and IC directors began to plan a recommended itinerary to make the most of the secretary's time here. Office space in the NIH director's office had been cleared for Thompson's use during the 4 days he was on campus.
The timing of the visit coincidentally only 12 days following President Bush's announcement regarding the use of stem cells in federally funded research necessitated several briefings per day here among Thompson, Kirschstein, and NIH associate director for science policy Dr. Lana Skirboll on the stem cell issue. On the Monday after Thompson's visit, NIH announced a plan for implementation of the President's policy.
Alternative Medicine Briefing Has Wisconsin Flavor
By 11:30 on Monday, Aug. 20, Thompson was meeting with Dr. Stephen Straus, director of the National Center for Complementary and Alternative Medicine, and Dr. Richard Nahin, director of NCCAM's Division of Extramural Research and Training, on bringing science to complementary medicine. The Secretary had already that morning completed meetings with Dr. Maria Freire and staff of the technology transfer office, and NCI director Dr. Richard Klausner regarding cancer drug development.
Far from giving a merely ceremonial briefing, NCCAM's Straus used a series of flashcards to illustrate methods the center uses to determine whether complementary and alternative medicine (CAM) approaches are clinically safe and effective. Straus explained that according to national estimates, approximately 42 percent of Americans use some forms of CAM alone or in combination with conventional medicine, and that many so-called mainstream physicians are prescribing such unproven treatments. NCCAM's role, Straus emphasized, is to "use the tools of science to determine what CAM therapies are safe and effective and to arm the public with this information."
Thompson mentioned that he had toured several Indian reservations in Alaska, Michigan and South Dakota during the previous week, and "was amazed at how the clinics were using sweat lodges, herbs and other old Indian traditions. [Do] you think some of these methods work?"
Straus replied, "The question is which of them work and how well."
Thompson asked specifically about such popular CAM substances as St. John's wort, which Straus explained is currently being studied in a 340-patient multicenter trial supported by NCCAM.
What about other herbal drugs? Thompson inquired. "Are you going to be doing research on those?"
Nahin responded that a 6-year placebo-controlled study comparing placebo pills with ginkgo biloba to test whether the herbal product can prevent or delay the onset of dementia in the elderly is currently recruiting patients. The trial is funded jointly by NCCAM, the National Institute on Aging, the National Heart, Lung, and Blood Institute and the National Institute of Neurological Disorders and Stroke. About 1,500 patients have been enrolled to date, Nahin said; a total of 3,000 are sought for the study.
As an example of a popular alternative remedy not yet proven effective but of interest to supporters of conventional as well as unconventional medicines, the NCCAM briefing team had brought a presentation on products used in clinical research such as cranberry juice and other cranberry products. [Wisconsin the state where Thompson was born, reared and elected governor for 14 years before leaving in the middle of his unprecedented fourth term to become HHS secretary is one of the nation's largest producers of cranberries.] NCCAM is putting the final touches on a cranberry initiative, which seeks to assess the effectiveness of cranberry products in the prevention of urinary tract infections.
"Cranberry juice is one example of the kinds of supplements the public is using," Straus told the Wisconsin native.
Other topics covered during the 30-minute session included acupuncture, ephedra, chiropractic, and ginseng ("Ninety percent of ginseng is grown in three counties in Wisconsin," the secretary pointed out).
"I can't tell you how impressed and appreciative I am of your work here," Thompson said. "I have to admit that I hear very mixed opinions about these things. But, you're probably going to save more lives and more money, and improve health options for the public more than we can even imagine."
Distributing the Fruits of NIH Science
After having lunch Monday with NIH senior staff and IC directors, the secretary met with Dr. Bruce Fuchs, director of NIH's Office of Science Education, who discussed the curriculum supplement series that OSE offers to science teachers nationwide. In 18 months, Fuchs reported, 40,000 copies of the series's first installments on cell biology and cancer, emerging and re-emerging infections and human genetics have been shipped across the country.
"We use our scientists here to see what teachers and students need to know about these topics," Fuchs explained. He also pointed out that with each copy of the supplement, OSE estimates it reaches about 100 students, who in turn may discuss the science with their parents. "We're pleased that a lot more teachers are learning about the material and requesting it."
As a former governor involved with education initiatives, Thompson was asked to help OSE find additional ways to reach teachers, students and others involved in national and state school issues.
Next, the secretary was off to tour the Vaccine Research Center in recently occupied Bldg. 40. After a 40-minute briefing on global health research by NIAID director Dr. Anthony Fauci, VRC director Dr. Gary Nabel, Fogarty International Center director Dr. Gerald Keusch and acting Office of AIDS Research director Dr. Jack Whitescarver, Thompson was led to one of the biosafety level 3 vaccine production facilities in the building.
Fascinated to see where cutting-edge vaccine science is conducted, the secretary wanted to know why NIH could not be the ultimate distributor of any effective HIV/AIDS vaccine that the agency produces. Fauci explained:
"It's not in the NIH mandate to manufacture and distribute vaccines," he said. "We do the basic research and generally partner with industry in the early development of the vaccine, while FDA approves the vaccine and CDC is involved in the large scale distribution of the product."
Continuing to point out features of the production facilities, Fauci and Nabel talked with cautious optimism about a few of the most exciting developments in vaccine research.
"The first vaccine will probably not be a home run," Fauci predicted. "More like a single."
"However, you can do a lot of batting down the epidemic with only a partially effective vaccine," Nabel emphasized, sharing a nod of agreement with Kirschstein, whose early career in research involved testing the efficacy of the polio vaccine.
"If we can lower the peak," Nabel continued, "or even the amount of the virus in a person's system, then we can limit the number of people passing it on."
Thompson was then shown one of the HIV cell analysis laboratories that is housed in Bldg. 40. There, he was told, scientists use flow cytometry and high-speed cell analyzers to examine individual cells in the blood, measure which people respond to a drug and quantify which test vaccines are most effective.
A briefing on the Human Genome Project, tours of a microarray facility in Bldg. 49, the National Library of Medicine and the National Center for Biotechnology Information, and demonstrations of Medline and clinicaltrials.gov concluded the secretary's first day.
NIH Intramural Research In Depth
On day two, Gottesman and NIDDK director Dr. Allen Spiegel met with Thompson for more detailed talks on intramural research. Gottesman explained the budgetary allocations whereby more than three quarters of NIH's appropriation goes to extramural research and about 10 percent goes to science conducted within the intramural program.
Recalling all he had learned on his NIH visit to date, Thompson asked Gottesman, "You do such wonderful work. Why do you limit yourselves to 10 percent of the budget?"
Smiling at the compliment, Gottesman replied that a study had been conducted under former NIH director Dr. Harold Varmus to help determine the levels at which intramural, extramural and research support programs should be funded. "Over the years, we [the intramural research program] have grown," Gottesman said, "but not at the same pace as extramural. The numbers of principal investigators have declined as well. And, truthfully, we do not have enough physical space for more researchers. Finding the right balance is key."
Thompson was then introduced to two aspects of structural biology. Dr. David Davies, chief of the molecular structure section in NIDDK's Laboratory of Molecular Biology, discussed x-ray crystallography and how scientists discovered the three dimensional structure of such key HIV proteins as protease and integrase. Dr. Marius Clore, chief of the protein nuclear magnetic resonance spectroscopy section in NIDDK's Laboratory of Chemical Physics, explained NMR and how it helped determine the three-dimensional structure of a key protein HIV uses to infect healthy cells. Davies and Clore emphasized the importance of structural biology in drug and vaccine development.
A hard hat tour of the construction site for the Clinical Research Center, and a visit to the Blood Bank to make a donation capped the secretary's second day here.
On Wednesday, the secretary stopped in briefly at the scientific directors' meeting and spent part of the morning on the computer, learning about electronic research administration and receiving a hands-on demo of NIH's web site. After lunch with HHS agency heads, Thompson visited several patient care units in the Clinical Center and the NIH-supported Stroke Center at Suburban Hospital.
On a shortened schedule Thursday Thompson's last day on campus he had briefings on child health and education, and an update on the spread of the West Nile virus. Lunch was a pizza party and a tour of the Children's Inn, which completed his working visit here.
This marks the secretary's fourth official visit to NIH since assuming the reins of HHS and the third in the month of August. His first official press briefing was held in Wilson Hall in February; he announced the results of a major diabetes prevention trial at a press conference in Lister Hill Auditorium on Aug. 8 and answered questions Aug. 10 about stem cell research and the President's policy announcement on Aug. 9.
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