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February 7, 2012 Advisory Board Meeting Summary Minutes
Department of Health and Human Services
Public Health Service | National Institutes of Health
John E. Fogarty International Center for Advanced Study in the Health Sciences
Seventy-sixth Meeting of the Advisory Board
Minutes of Meeting
February 7, 2012
The John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) convened the seventy-eighth meeting of its Advisory Board on Tuesday, February 7, 2012, at 9:00 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The closed session was held on February 6 , as provided in Sections 552(b)(4) and 552(b)(6), Title 5, U.S. Code, and Section 10(d) of Public Law 92-463, for the review, discussion and evaluation of grant applications and related information. The meeting was open to the public on February 7, 2012 at 9:00 a.m., until adjournment at 3:00 p.m. Dr. Roger I. Glass, Director, FIC, presided. The Board roster is appended as Attachment 1.
Board Members Present
Dr. Roger Glass, Chair
Dr. Robert A. Black
Dr. Gail H. Cassell
Dr. Maria Friere
Dr. Peter Hotez (via telephone)
Dr. Bonita Stanton
Dr. Alan Guttmacher, NICHD/NIH (ex officio)
Board Members Absent
Dr. Roscoe Moore
Dr. Arthur Reingold
Dr. Sten Vermund
Dr. Derek Yach
Dr. Susan Shurin (ex officio)
Members of the Public Present
Dr. Michele Barry, Stanford University
Dr. George Hill, Vanderbilt University
Dr. Patrick Kelley, Institute of Medicine, Washington, DC
Dr. Michael Merson, Duke University
Dr. Funmi Olopade, University of Chicago
O. Pannenborg, World Bank
Dr. Rebecca Richards-Kortum, Rice University
Dr. William Tierney, Indiana University
Federal Employees Present
Nalini Anand, FIC
Danielle Bielenstein, FIC
Dr. Kenneth Bridbord, FIC
Kasima Brown, FIC
Julie Burke, FIC
Ann Cashion, NINR
Dr. Arun Chockalingham, NHLBI
Dr. Lois Cohen, NIDCR
Pamela Collins, NIMH
E. Ann Davis, FIC
C. DiFrancesca, NIH
Robert Eiss, FIC
Patricia Grady, NINR
Dr. James Herrington, FIC
Dr. Flora Katz, FIC
Lydia Kline, FIC
Deborah Langer, ODP
Dr. Enid Light, NIMH/FIC
Susan Maier, ORWH
Damali Martin, NEI
Kristin McNamara, FDA
Dr. Mark Miller, FIC
Elise Morocco, FIC
Wendy Nilsen, OBSSR
Satabdi Raychowdhury. FIC
Dr. Joshua Rosenthal, FIC
Lana Shekim, NIDCU
Larry Slutsker, CDC
Caroline Sennefeld, FIC
Dr. Ted Trimble, NCI
Kall Wester, NIAID
Kristen Weymouth, FIC
Makeda Williams, FIC
Dr. Linda Wright, NICHD
Mr. Sean Jeffrey, FIC/NIH
- Limited Competition: Global Health Program for Fellows and Scholars (Global Health Fellows) of 8 of 9 applications, for a total of $8,000,689.
- International Research Ethics Education and Curriculum Development Award (BIOETHICS) of 12 of 23 applications, for a total of $3,058,128.
- Climate Change and Health: Assessing and Modeling Population Vulnerability to Climate Change of 2 of 2 applications, for a total of $237,900.
Director's Update and Discussion of Current and Planned FIC Activities
Dr. Roger Glass
Dr. Glass welcomed Council members, federal staff and guests present, and briefly reviewed the agenda. He noted that Dr. Ted Trimble, the director of the newly established NCI Global Health Center, would discuss the Center's activities; and that Dr. Roderick Pettigrew, Director of the NIBIB, would review the Institute's research activities.
Dr. Glass congratulated five retiring members of the Advisory Board, expressing his appreciation for their service and assuring them that they would become Board members "emeriti" and be welcome at future Fogarty Board meetings - Drs. Bob Black, Peter Hotez, Roscoe Moore, Art Reingold and Sten Vermund. He reminded the Board that Maria Freire, a Board member who was absent at the last meeting because of her responsibilities in presenting the Lasker Awards, had informed the Board that the awards went to Tu Youyou for her development of artemisinin, and to the NIH Clinical Center for serving as a model of an effective research hospital (the award was accepted by Dr. John Gallin, director of the NIH CC). Finally, he mentioned that immediately after the last Board meeting he, Dr. Harold Varmus, NCI Director and Dr. Francis Collins, NIH Director, had attended a high level UN General Assembly meeting on emerging global interest in non-communicable diseases, an area of research that was included in the Fogarty strategic plan five years earlier.
At the Board's dinner the day before the open meeting, Dr. Nils Daulaire, Director of the DHHS Office of Global Affairs, discussed the new Global Health Strategy, which is now available on the DHHS website. Dr. Glass commented that Fogarty is committed to developing stronger relationships with DHHS, as well as USAID and PEPFAR. An important part of that effort will rely on former Board member Dr. Ariel Pablos-Mendez, who is now ex officio and is the USAID Assistant Administrator for Global Health. Under his leadership USAID will expand its involvement in Grand Challenge awards and in funding innovation in US educational institutions.
Dr. Glass expressed Fogarty's support for the AIDS-Free Generation program, endorsed by Secretary of State Hillary Clinton, and mentioned the 052 trial of treatment as prevention at the University of North Carolina by Dr. Mike Cohen, who has been a strong advocate for Fogarty programs. Finally, Ambassador Eric Goosby delivered the 11th Annual Barmes Lecture, the subject of which was PEPFAR: Moving from Science to Program to Save Lives. Dr. Ariel Pablos-Mendez presence at USAID should improve Fogarty's interaction with the agency. Ambassador Goosby has also lent his support to the fledgling MEPI, which is supporting medical institutions in 13 countries. Finally, he announced that a collaboration between the Peace Corps and the Consortium of Universities for Global Health will begin recruiting experienced physicians and others in public health to volunteer to work at overseas sites, including perhaps MEPI sites.
Dr. Glass explained that the CUGH, supported in its origins by former Fogarty Director Dr. Gerald Keusch and current Board member Dr. Bob Black, has been a Fogarty constituency since its first meeting on the NIH campus in 2009. Its last annual meeting drew over 1,500 attendees.
The BRIC countries were a focus of discussion at the last Board meeting, and Dr. Glass noted that relationships with Brazil, India and China have been improving; Russia, however, has been more challenging. On November 16 through 18, the US-Russia Scientific Forum in Biomedical and Behavioral Research was held in the US. Board member Dr. Gail Cassell and the Foundation for the NIH were important in causing the meeting to happen, which focused on partnerships with Russian scientists in maternal and child health, healthy lifestyles, obesity, drug abuse, tobacco use, cancer and infectious diseases, including HIV infection and TB. Dr. Glass added that the political climate in Russia is a factor, which hopefully will ameliorate later in the year when a second meeting is planned.
Dr. Glass described the trip abroad that Dr. Francis Collins began in November, starting with the Global Alliance for Chronic Disease (GACD) meeting in Canberra, Australia on November 29, followed by the HIRO meeting on November 30. Board member Dr. Susan Shurin was named president of GACD, a consortium of medical councils in certain OECD countries, and the outcome of the meeting was agreement to focus on chronic diseases in general, and hypertension specifically. An RFA with five collaborating countries will be funded collaboratively, each country funding its own researchers.
The next stop on Dr. Collins' trip was Bangalore, India, where he met a number of NIH-funded scientists (NICHD, NIAID, NHLBI and Fogarty) working on a broad range of issues, and signed a stem cell research agreement with the Indian Center for Biological Sciences. Finally, he spoke several times to young scientists in the Indian Institute of Science. Next was New Delhi, where Dr. Collins joined the MedTech meeting and discussed a collaboration with NIBIB on point-of-care diagnostics. He visited the Indian Institute of Technology, a leading engineering center, which has formed a partnership called the All India Institute of Medical Science, which includes in its membership both physicians and engineers. Finally, he visited the Public Health Foundation of India, where four NIH grantees are working on diabetes, infectious diseases, smoking and cancer, and mental health. While there he signed an agreement to collaborate on a diabetes study.
Returning to the U.S., Dr. Collins attended the mHealth Summit (December 5-7) at National Harbor in Washington, DC, a meeting that drew more than 3,500 mainly commercial partners in global health. There was a very broad variety of innovative devices, but little actual evaluation of efficacy in the field. There is a small study group at NIH looking at a strategy for mobile health research.
Dr. Glass commented that in January he returned to India with Secretary Sibelius, her first trip to India, to participate in the first anniversary of the last diagnosed case of polio in India. She spent four days visiting various NIH projects in India, including an intervention study of high school students to encourage behavioral change related to avoidance of smoking, alcohol, violence, and encouragement of a more active lifestyle. The students in this study encouraged 70,000 students to send postcards to legislators to ban smoking on Bollywood property. The Secretary visited BJ Medical College in Pune, a small institution that has been working on AIDS for 20 years, having undertaken the first preventing mother-to-child transmission trial (PMTCT) in India. The college has participated in the Nevirapine study and has successfully lowered the incidence of HIV infection in the area. Dr. Glass added that it all began 20 years ago with an AITRP-funded Fogarty program led by Dr. Bob Bollinger.
The next stop was a small medical school in Belgaum which has had about a dozen NIH grants during the last ten years, including a misoprostol study to prevent maternal hemorrhage and another study to assess the effects of asphyxia in neonates. The final visit was to Tata Memorial Hospital in Mumbai, where she learned that the main tobacco problem is an increased risk of oral, head and neck cancers from chewing tobacco and betel. One surgeon organized a number of his cancer survivor patients into an advocacy group to promote prevention or cessation of tobacco use.
Dr. Glass invited Dr. Jim Herrington to comment on his visit to Bamako, Mali, to encourage cooperation between the governments. Dr. Herrington explained that there were several stakeholder meetings with NIH and USAID to identify mutual interests with the Malians. The first of several science-for-development meetings took place in late January with Mali, and there have been indications of interest from several other countries for similar conferences - Ghana, Ethiopia and Indonesia. Over a hundred Malian government representatives and scientists from a dozen agencies, plus staff from USAID, the Peace Corps, CDC, DoD, FIC, NIAID and NCI attended the Mali meeting. Dr. Herrington noted that Mali is a GHI country. The GHI platform encourages a comprehensive whole-government approach to health care, country ownership of research, long-term sustainability of programs through scale-up of innovations. Ambassador Jimmy Kolker was the keynote speaker, focusing on the need for evidence-based development of policies and practices.
Dr. Herrington summarized the results of the Mali meeting, noting that several breakout groups arrived at the following "next steps:" increased reliance on evidence-based practices for medical care; expansion of misoprostol to non-hospital settings (e.g., community health care workers) to prevent postpartum hemorrhage; include point-of-care CD4 testing and HIV rapid testing at the community level; improved lab diagnostics quality and capacity; expanded cervical cancer testing and HPV vaccine programs; and support for the Program for Enhanced Engagement in Research (PEER), which funds local researchers vetted by the NIH.
Dr. Glass briefly reported on MEPI, which will have its annual meeting in Ethiopia in August. The new Global Health Program for Fellows and Scholars continues to expand, and some will be involved in MEPI sites. The program offers a one-year training opportunity. The first surgeon to complete the program is now in Rwanda, having begun a survey of emergency and essential surgical capacity there. The first pediatric cardiologist to complete the program is in Malawi. Both graduates have extended their tours to include a second year. Under the Fulbright-Fogarty Fellowship Program for medical school students, established in 2010, four students are now in Africa, and 17 more were recently selected from over 77 applications to be reviewed for placement. The Fulbright-Fogarty Postdoctoral Program has recently been approved and ten sites in eight countries will be included in the 2013-2014 awards.
Dr. Glass introduced Dr. Ellis McKenzie, chief scientist for FIC's Division of International Epidemiology and Populations Studies, who directs Research and Policy for Infectious Diseases Dynamics (RAPIDD) in that Division. Dr. McKenzie explained that Fogarty has been a leader during the past decade in infectious disease modeling and its intelligent use in policy and decision support. Fogarty hosted a meeting that included policy makers and stakeholders that resulted in working groups under the aegis of former Secretary of DHHS Thompson, which looked at modeling smallpox and anthrax. The value of modeling became clearer and DHHS provided some funding to establish RAPIDD, which has grown to about 70 individuals working on a broad range of infectious disease modeling. RAPIDD has recently produced four tenured postdocs and is working with eight more candidates. Members of RAPIDD have produced more than 200 peer-reviewed papers in Science and Nature.
Finally, Dr. Glass mentioned that Fogarty is working with the World Bank, which has made significant investments in IT and communications, mobile health, and educational institutions. With the current interest in non-communicable diseases, the importance of mHealth and eLearning, Fogarty is in a good position to support the World Bank's efforts.
Dr. Glass invited discussion. Dr. Hotez observed that, since former Board member Dr. Ariel Pablos-Mendez is leading USAID into a more active role in global health, that Fogarty could become involved in such programs as the recently announced $100 million RFA to help universities develop initiatives in the international arena, a program that could have been administered by Fogarty. Dr. Cassell noted that, if review of applications is internal at USAID, Fogarty would be a good partner to encourage peer review. Dr. Merson stated that outside peer review was part of the RFA, and Dr. Glass added that a recent Grand Challenge award through USAID was, in fact, reviewed by NICHD, although that institute was not part of the RFA. He noted that Dr. Jim Herrington's earlier remarks about the Mali meeting reflected the first effort to bring federal agencies together in the field, which is where most USAID grants are made. He said that Dr. Pablos-Mendez had remarked that Fogarty should inform FIC alumni about those opportunities and encourage them to make embassies in their areas aware of their presence.
Asked about the NIMH centers of excellence in Latin America and Africa, and whether the focus is broad or narrow, Dr. Glass explained that the centers were NIMH's first steps, basing them on the NHLBI model. Fogarty will continue to cooperate with NIMH, and is now trying to locate psychiatrists and epidemiologist who might be willing to participate in the centers' activities. Ms. Anand added that there is an implementation research focus in the design of the centers, since NIMH felt there is a gap in that area. The centers will look at integration of mental health services into existing health care delivery platforms.
FIC Strategic Plan
Dr. Glass explained that when he arrived at Fogarty, he began working on a strategic plan that ultimately had five goals: to help the scientific community to address the shifting global burden of disease; to bridge the training gap in implementation research; to develop human capital to meet global health challenges; to foster a sustainable research environment in low and middle income countries (LMICs), and to build strategic alliances and partnerships in global health training and research.
In response to those goals, Dr. Glass pointed to a number of responses within NIH, including new and expanded FIC programs - Lifespan, a program focused on chronic, non-communicable diseases and disorders that provides funding for collaborative research with U.S. and lower middle income countries (LMIC) research institutions; tobacco control and prevention research; work with neuroscience researchers in brain science; and the new Fellows and Scholars Program. Fogarty has worked with NHLBI in their centers of excellence in chronic diseases, with NIMH in their Grand Challenge programs in mental health, and with NCI's newly established Global Health Center.
On a more global scale, Dr. Glass mentioned Fogarty's connection with the Global Alliance for Clean Cookstoves and the effort to reduce indoor pollution, and participation at the UN meeting on non-communicable diseases in November 2011. He noted there had been challenges in mobilizing efforts to promote long-distance learning and, although the MEPI program has 36 participating medical schools, there is a serious shortage of professors.
Dr. Glass commented that, with significant funding for research in the field, there is an important need for effective research management and administration of that funding. Fogarty has joined NICHD's established program to train research administrators, and PEPFAR recently provided additional funding for that program.
Dr. Glass mentioned other existing program areas that merit funding and focus - biomedical ethics, informatics, building partnerships with the BRIC countries, and building alliances and partnerships within the federal government (USAID, PEPFAR, Peace Corps, Fulbright, CDC, and other NIH institutes and centers). Of Fogarty's budget, 88% of grants are made in partnership with other institutes and centers. Dr. Glass conceded that Fogarty does not have significant expertise in the various specific research fields, but it does have significant expertise in the international arena, including understanding the research landscape, building relationships, facilitating documentation (letters of intent and memoranda of understanding). Finally, two works in progress are MEPI and the Building 16A Think Tank. He invited Dr. Rachel Sturke to comment. With Ms. Nalini Anand, she will be coordinating the process to arrive at the next strategic plan.
Dr. Sturke briefly outlined the three steps up to the development of the strategic plan draft. Within NIH, comments will be solicited from the Advisory Board, FIC staff and representatives of other ICs. Second, external input will come from outside stakeholders like CUGH and HIRO, and by having a stakeholders meeting at the Global Forum for Health Research meeting. Third, web input will be sought and perhaps interactive conversation on the web will be supported by Building 16A technology.
Dr. Cassell recalled an earlier retreat that included private sector participants. She felt it might be useful to consider a similar brainstorming meeting with carefully selected participants, perhaps some from the previous mHealth Summit. Dr. Stanton commented that two other stakeholders might be considered - representatives of countries that have not been able to benefit from Fogarty's programs, and greater contact with recipient countries, such as the BRIC countries.
Dr. Black commented that, although implementation science is prominent in the current strategic plan, success has been spotty. He suggested a critical review of what has and has not worked in implementation science with an eye toward developing a more specific strategy. It was observed that scale-up is a challenge to innovation, and looking at partnerships with the private sector may help reduce the "valley of death" effect that is often caused by an inability to accomplish scale-up.
Dr. Merson commented that the global science environment is rapidly changing because of economic pressures, the increasing prominence of China and India in the research arena, the changing demographics of college students, and universities becoming more global. He suggested that a priority strategy should be working to stay ahead of those changes. There was a comment that bioethics should be considered in developing strategies, not only training researchers in the U.S., but including training for those in the recipient countries.
Closing the discussion of the strategic plan, Dr. Glass introduced Dr. Greg Germino, Deputy Director of NIDDK. Dr. Germino announced that NIDDK was working on a joint venture with the Indian government to address the problem of diabetes in India, where it is estimated that 61 million are affected. There are over 35 million diabetics in the U.S., so it is an appropriate joint issue for the two countries. Currently NIDDK has a limited presence in India, including a program at one medical college, some participation in the NHLBI center of excellence, and a few grantees at Emory University.
Dr. Germino stated that part of his December mission to India was to identify opportunities for collaboration and to discern why, since there are exceptional scientific and clinical opportunities there, NIDDK investigators have not taken advantage of them. He suggested that one problem might be an unfamiliarity of the Indian scientific environment, a lack of experience in developing partnerships, limited reciprocal training that would increase the contacts that NIDDK scientists would otherwise have, and a sense that logistical barriers are significant.
Dr. Germino said that the agreement is being written and it is hoped that, after review by the Indian government, the agreement will be final by May. Then a joint committee could be established to plan a preliminary meeting in late 2012, which would be attended by the leading experts from NIDDK and the U.S, and the Indian science community to develop a research agenda. The goal is to jointly fund projects in 2014 and working with Fogarty, work out some joint training experiences for scientists in both countries.
Integrating Cancer Control into Global Health: Establishment of the NCI Global Health Center
Dr. Ted Trimble, Director, NCI Center for Global Health
Dr. Olufunmilayo Olopade, Director, Center for Clinical Cancer Genetics and Global Health, University of Chicago
Dr. Glass commented that NCI had recently appointed Dr. Ted Trimble to lead the NCI Center for Global Health. He invited Dr. Trimble to discuss the Center and how Fogarty might support its new direction.
Dr. Trimble stated that his medical background was in ob-gyn, with additional focus on obstetrical oncology, specifically cervical cancer. He commented that improving access to care is a primary consideration of any program, but that in the experience of NCI and other institutes, international collaborations are hampered by red tape. An informal working group, now formalized with Fogarty's help, was established to look at administrative and regulatory barriers to international collaboration.
Dr. Trimble reviewed cancer risks as they affect NCI research collaborations. With improved infant survival, individuals live longer, which increases cancer risk in later years. Additional risks that are present in the global community include tobacco use, infection, poor diet, lack of physical activity, and others. Statistics taken from the GLOBOCAN database of the International Agency for Research on Cancer show that cancer in middle income populations has increased from 55% to 66%, and it is estimated that 70% of cancer deaths will be in lower middle income countries by 2030. Some of the cancers are treatable or preventable. One of the best candidates for prevention is tobacco use, which influences the risks for cardiovascular disease, cancer and COPD. In China, 67% of men smoke, but only 2% of women smoke. In the U.S. smoking in men has leveled off at 24%, in women at 19%. Infection causes a number of cancers. Helicobacter pylori can cause stomach cancer, human papillomavirus can cause a variety of cancers, including cervical cancer.
Obesity is a well-known cause of diseases, including cancer. Unlike China, where the obesity rate in men is 27% and in women 22%, the rates in the U.S. are much higher, 72% in men and 70% in women. Obesity has been linked to increased risk of uterine cancer, and cancer of the kidney, cervix, pancreas and esophagus.
Dr. Trimble commented that NCI has been involved with a number of vaccines, including development of the HPV vaccine, which for too long was priced out of the reach of the global markets. Finally, the early $120 per dose for three doses was lowered to $5 per dose, still costly for some developing countries. An NCI-sponsored trial in Puerto Rico completed epidemiology that indicated that two doses were as effective as three, lowering the total cost even more, but still not low enough for some countries. Another example of ongoing NCI research is the development of platinum-based chemo radiation for locally advanced disease, a treatment that has become the standard of care - but many don't have access to facilities that offer either the chemo radiation or surgery.
Dr. Trimble pointed out that NCI has four established international offices - a liaison office in Brussels, the Office of International Affairs, Office of Latin American Cancer Program Development, and Office of China Cancer Program Development, all located in Bethesda. Dr. Varmus, NCI Director, arrived committed to strengthen NCI's global commitment, and the new Center for Global Health is in place to support that goal. The Center incorporates the four older offices mentioned.
Oversight of the Center rests with the National Cancer Advisory Board's Subcommittee on Global Health, on which Dr. Funmi Olopade sits. Priorities for the Center that are under consideration include cancer control planning and implementation; cancer research related to chronic infections; research on high incidence cancers in specific ecological niches (e.g., the exceptionally high rate of gall bladder cancer in Chile); and strengthening the infrastructure for cancer research. With regard to the latter, the agenda includes improving pathologic diagnosis, training nurses in clinical research, establishing bio banks, training grants administrators, and helping investigators work in the lower middle income countries as well as in their university settings. Finally, Dr. Trimble stated that there is interest in supporting NCI-designated cancer centers that might develop ties with sites in the developing countries.
Dr. Trimble expressed the opinion that the Center could learn from existing global health research activities, including how to support translational research into the clinical setting as well as a way to influence public health policy. He noted that there were a wide array of partnerships, from collaborations with other U.S. federal agencies concerned with global health, to associations and professional societies, to partnerships with the fifty NCI-designated cancer centers, medical and nursing school, and the increasingly important need to foster partnerships with pharmaceutical and biotechnology companies in the private sector. Finally, there should be significant effort to ally with international groups, such as WHO and the International Atomic Energy Commission, which has dedicated $12 million to improve access to radiation-related treatment globally. Ending his discussion, Dr. Trimble introduced Dr. Olopade, who made comments from the real-world perspective.
Dr. Olopade commented that NCI Director Dr. Harold Varmus put global health prominently on the NCI agenda, and appointed Dr. Olopade to chair the National Cancer Advisory Board's Subcommittee on Global Health. The Subcommittee is composed of academicians, clinical researchers, representatives of private industry and patient advocates. A first step was to map the global research community and try to identify high resource, high capacity areas, such as China, which is able to direct significant resources into global health research. Another possibility is the BRIC countries. But there should also be attention directed at low resource, low capacity groups that might be candidates for investment.
Dr. Olopade described the African Organization for Research and Training in Cancer (AORTIC). Formed in the eighties, AORTIC's first contribution was to train oncologists in the U.S., who would return to Africa and develop their own clinical trials. An early success was development of a treatment protocol for Hodgkin's disease that did not rely on elaborate radiation therapy, which was then the standard of care. Now treatment of Hodgkin's disease is based on that early research in Africa. AORTIC's first formal meeting was held in Ghana in 2002 with about 80 U.S. and Africa-trained researchers. At the last meeting in Cairo there was agreement to align initiatives with what NCI was doing in Africa. There was also agreement that a partnership with the MEPI program would be helpful in promoting oncology training in the African MEPI institutions, with less reliance on training in the U.S. One innovation, shepherded by NCI's Dr. Joe Harford, is a program called BIG CAT, Beginning Investigator Grants for Catalytic Research, which supports young researchers who may not be eligible for direct NIH funding. It is managed by AORTIC.
Private organizations are funding projects in Africa, and Dr. Olopade stated that there should be an effort to coordinate and integrate these programs to increase the potential for success and to reduce duplicated efforts. She noted that the International AIDS Conference, cooperating with Fogarty and NIH, is promoting the development of cancer registries that will more clearly define the disease burden.
Dr. Glass expressed appreciation for the two presentations and, before inviting discussion, introduced Dr. Flora Katz, Deputy Director of the Division of Extramural Research at FIC, who discussed the Fogarty resources that might complement the NCI initiatives. Dr. Katz briefly described four Fogarty divisions that could support NCI's Center for Global Affairs. First, the Division of International Training and Research, which is well known to the Board, handles Fogarty's extramural program portfolio. Second, the Division of International Relations has expertise in brokering agreements between NIH ICs and foreign institutions and governments. Third, the Division of International Science Policy, Planning and Evaluation which provides planning and evaluation services to Fogarty staff, as well as advice on international science policy, legislation and partnerships. Fourth, the Division of International Epidemiology and Populations Studies covers epidemiologic studies and modeling, especially infectious disease modeling.
Dr. Katz described NCI co-funding to Fogarty, which peaked in 2008 at more than $4 million, but was still a significant $2.5 million in 2011. Programs receiving the most funding were the Tobacco/India AIDS program and the Fogarty Scholars Program. Fogarty co-funding to NCI has dramatically increased in the past two years, from less than $50,000 from 2006 to 2009, to over $300,000 in 2010 and 2011.
Dr. Katz pointed out that there are several points of intersection between Fogarty and NCI - a common interest in Global Health in the 21st Century, agreement that more stakeholders should be included in the mix, and a broader invitation to participate in grants. She noted that programs should build on capacity already in place, and build on the existing infectious disease infrastructure to include non-communicable diseases. Fogarty and NCI can co-localize where either has strength, and of course, encourage collaboration on programs.
Dr. Katz mentioned several examples. The Global Health Program for Fellows and Scholars should increase the number of fellows funded in cancer research. NCI's T32 grantees would be helpful in that regard. The Framework Programs for Global Health Innovation is a unique program, experimenting with new interdisciplinary approaches. The first applications have just been received. NCI's interdisciplinary centers should be expanded, such as the nano-biology centers that include collaborations between engineers and biomedical scientists. The NCD-Lifespan program provides opportunities, such as expansion of the inflammatory breast disease program in Egypt that is now expanding to Morocco and Tunisia.
Fogarty has recently announced a planning grant solicitation to develop regional centers around the world to look broadly at environment and workplace health risks, and cancer is a significant factor that offers the possibility of collaboration with NCI. Finally, there is the longstanding program in bioethics that trains individuals in a number of countries to deal with issues such as IRBs, registries, repositories, guidelines and so on.
Dr. Glass invited discussion of the three presentations. Dr. Merson offered three comments. First, he stated that drug prices were coming down in certain cancer drugs and that demand for treatment should begin to increase, something that Fogarty should consider in developing future research and treatment programs. Second, he felt that cancer treatment should not be owned by university cancer centers, but that there should be a much more diverse investment by other stakeholders in cancer treatment. Third, there are many players in the cancer field in the U.S. as well as globally, and programs should be aware of the skills available in other countries. He noted that some of the best HIV prevention and AIDS treatment in the developing countries came from Fogarty investments. He encouraged research by in-country investigators, supported by Fogarty in programs driven by NCI. Dr, Merson suggested looking at the early NIAID AIDS research model, as well as the more recent NHLBI cardiovascular diseases program, both of which relied on PIs from the developing countries, a stand that was controversial when the programs were begun.
Dr. Hotez encouraged support of research in neglected causes of cancer in lower middle income countries, especially cancers caused by infections. He commented that etiologies can be unique to certain diseases and as more etiologies are identified, the percentage of infection-based cancers may rise from the current 20%. He gave the example of 400 million in Africa with schistosomiasis, a leading cause of bladder cancer, and liver fluke that may be responsible for 20 million cancer cases in Laos, Thailand, Cambodia and parts of China. He suggested that NIH had not funded research in either.
Dr. Cassel suggested that Fogarty consider adding an industrial relations division to address the interaction between the private sector and Fogarty research interests. She felt that was particularly appropriate in chronic diseases and the emerging onclytic science, and the global need to reduce drug costs. Proactively interacting with industry would be a positive step.
Dr. Kelley stated that the Institute of Medicine published a report in 2011 about palliative care, summarized in the New England Journal of Medicine in January 2012. He asked if palliative care should be a part of the global NCI agenda. Dr. Trimble commented that such care is prominent in the NCI agenda, with a grant at the University of California, San Diego to train care providers. NCI is also partnering with the American Society of Clinical Oncology, the International Union Against Cancer, and other organizations to improve access to morphine and to educate providers in palliative care. In another area, Dr. Trimble added that access to chemotherapy drugs, particularly generic drugs, is an issue because NCI does not have the capability of delivering quality, non-counterfeit drugs in the clinical setting overseas. Conducting clinical trials of chemotherapeutic regimens in those countries is also challenging because of the lack of infrastructure.
Dr. Olopade added that the frustration that such a limitation causes is part of the reason for the brain drain - physicians just leave when they feel helpless to provide such care. When some do return to try to build local capacity, it is important that they rely on proven methods, and avoid mistakes made elsewhere. She described an innovative Ativan-based treatment for breast cancer, which is a model that shows that the large infrastructure built in the U.S. to treat breast cancer is not necessary. As well, some of the chemotherapies that are the subject of research are too expensive. Dr. Olopade suggested that one element of Fogarty-supported research might be to identify what works and what doesn't work.
Dr. Freire encouraged Fogarty to embrace the notion that there are different realities for different areas, and that basic research into those unique realities is an appropriate role. Training has also been a Fogarty forte and it should continue to be a high priority. Second, she agreed that cancer registries were essential to developing the epidemiology needed to effectively conduct cancer research. Finally, she noted that, concerning the cost and quality of drugs, there are lessons from infectious disease that could apply to the focus on chronic diseases. Dr. Trimble added that the registries, as part of a holistic surveillance approach, would provide the capability of giving countries advice on monitoring health and planning for the future. He suggested that IARC could be a collaborator in developing a plan to construct registries.
Dr. Stanton noted that, although pediatric cancer may not have the visibility of other types of cancers, there are opportunities to support global efforts, such as the COG model which includes efforts by St. Jude's' Children's Hospital and other COG partners to support partnerships overseas. Secondly, Dr. Stanton encouraged the focus on tobacco cessation to continue. The 17% tobacco-related cancer rate is rising, and although smoking in China is low among women, for example, those who visit China regularly have seen an increase.
Dr. Tierney observed that the early HIV programs in Africa resulted in a large increase in infrastructure to support HIV research, some that are detrimental to other aspects of the healthcare system, which was dealing with diseases that were more prevalent than HIV/AIDS. The recent response has been to build a global infrastructure that supports a wider range of diseases. He suggested that the new focus on cancer not be so narrow that it results in a cancer center type of structure that might drain resources from other non-cancer programs.
Secondly, he noted that the current aversion to bricks and mortar may not be appropriate to the needs in cancer treatment for physical facilities that must be built - surgical suites, radiation oncology facilities, probably on a regional basis. In many developing countries transportation to obtain treatment is a significant issue, such that housing may have to be provided for patients, and sometimes their families, because they simply cannot commute to a treatment center. There are various social structures that may have to be supported to provide effective treatment.
Finally, because the diagnosis and treatment of cancer is complex, there must be local needs assessments to determine what is required and whether it is accessible locally or whether access relies on regional capacity. Dr. Richards-Kartum agreed, pointing to the example of the physical facilities required in the U.S. for surgical pathology that might not be required if new technology was available.
Dr. Guttmacher made the final comment of the discussion, that the NCI Global Health Center was important because it raises the level of commitment of NCI to global health issues and research. It also offers NCI an opportunity to be more strategic in addressing those issues. He added that ICs tend to be more strategic in their domestic programs than in their international programs, an issue that merits consideration by each IC.
Dr. Glass expressed appreciation for the valuable comments made during the discussion. He expressed his confidence that Fogarty's experience would be an asset to NCI collaborations. He noted that NCI has a large number of postdocs from the developing world who would be good candidates for NCI training opportunities. Dr. Glass mentioned visiting the Tata Institute in India, a potential model, that is an organization funded by a wealthy Indian family, which functions on a hub and spoke framework, with 11 sites around India linked to Tata for developing standards of care and pursuing research and treatment.
Priorities in Global Health Technologies
Dr. Glass introduced the final session of the meeting, which would be in three parts - a presentation by Dr. Roderick Pettigrew, Director, National Institute of Biomedical Imaging and Bioengineering; a presentation by Dr. Rebecca Richards-Kortum from Rice University, and a review of Fogarty-NIBIB collaborations.
Dr. Rod Pettigrew, Director, National Institute of Biomedical Imaging and Bioengineering
Dr. Pettigrew began by articulating an overarching goal of improving functionality and reducing costs. He stated that early detection of disease can be enhanced by technological innovation and improved international access to those innovations. The technological systems that will do this must be platform-based, portable, and allow healthcare to be delivered at the point of contact, where the patient meets the health care professional.
Dr. Pettigrew recalled that the first agreement NIBIB signed with India in 2007 was for the development of low cost diagnostic and therapeutic technologies. That agreement led to a bilateral workshop to assess the process, which in turn led to an initiative on which NICHD and NIAID collaborated. A Program Announcement (PAR) was published to bring together research teams composed of scientists from both countries. The charge was to look at specific conditions and develop technology for diagnosis and treatment. The first PAR selected diabetes and the development of a glucose measurement device that would not require a needle stick.
After the initial activities, Dr. Pettigrew explained that regular meetings were held with leaders of the Indian Department of Science and Technology, and in the summer of 2011 there was a proposal to partner on a grand challenge, to identify a disease with high incidence in both countries that could be addressed by technological innovation and, equally important, had to be low cost. In December a summit meeting was held in India, at which Dr. Collins delivered the keynote speech. It was attended by academic and industry scientists and clinicians from both countries. After two days of discussions and brainstorming sessions focused on improving the management of hypertension, diabetes and cancer from the standpoint of early diagnosis. The final decision was made after the summit when there was time to consider the three diseases. Diabetes was finally selected because it is a worldwide problem, a serious mortality risk, easily treated but just as easily missed because it has no discernable symptoms. It was also the one condition of the three into which little research funding is directed.
Diagnosis is problematic because it requires regular testing with a monitor, which is inconvenient and somewhat cumbersome to use. So the technology goal of this program is to develop a passive blood pressure monitor that takes the measurement, records it and transmits it to the physician, includes a way for the physician to interpret the cumulative data, and provides some feedback to the patient on the efficacy of any medication that might be taken to manage blood pressure. That challenge will be developed as a funding opportunity this year. The Indians are on board and have agreed to provide funding equal to that provided by the NIH.
In another area, Dr. Pettigrew described an MOU with the Korean Institute of Science and Technology, to develop an area of science called "theranostics," a combination of therapy and diagnostics, which would be a technology that would, at the same time, diagnose and treat a condition.
Dr. Pettigrew provided several examples of technologies that fit the overarching goal mentioned at the beginning of the discussion. First, current ultrasound technology is a portable machine that rolls on wheels and costs about $160,000. He showed a device developed by General Electric, under a NIBIB grant, a held-held ultrasound that costs $8,000.
Another grantee developed a similar, small ultrasound device that generates high intensity ultrasound capable of dissolving or breaking up blood clots, such as those that impose such a high threat in deep vein thrombosis. Another device was developed, also hand-held, that functions as a nuclear magnetic resonance spectroscope that can take a small sample of fluid and electronically analyze it to identify cells and proteins that are markers for disease. It is powered by a cell phone, and contains software to make the analysis of the fluid. It can identify a variety of biomarkers of bacteria, viruses, drugs - anything for which a ligand can be identified. Results are available in about 30 minutes versus the two days required for conventional biopsies.
Dr. Pettigrew described another hand-held microwave accelerated metal-enhanced fluorescence device (MAMEF) that can probe for sexually-transmitted infections. A tissue sample is inserted, exposed to a microwave that analyses the cell releasing DNA, which is analyzed by a fluorescence process. If Chlamydia, for example, is present in the DNA, it is detected by the device, providing a positive diagnosis.
Finally, Dr. Pettigrew described one for the children, being developed at Georgia Tech, a patch with a number of vaccine-impregnated micro-needles so small that the child does not feel the injection. The patch stays in place and the tiny needles biodegrade within ten minutes and the patch is removed like a band-aid.
During discussion, asked how the hand-held ultrasound device could be further reduced in price so it would be affordable in developing countries, Dr. Pettigrew responded that such challenges will be part of the funding opportunities developed by the U.S-India collaboration. He added that such innovations would involve tradeoffs and it would be important to insure that the diagnostic and treatment goals are preserved in the new device.
Dr. Rebecca Richards-Kortum, Institute for Global Technology, Rice University
Dr. Richards-Kortum posed a challenge for bioengineering in global health - to make sure that innovation is made available to everyone. She suggested one unlikely approach is to take advantage of undergraduates, some of whom have shown exceptional creativity. She explained that Rice University has developed a minor in global health technologies, a project-centered curriculum that allows students to collaborate to find solutions to challenges submitted by healthcare professionals.
Dr. Richards-Kortum described an innovation that reduced the cost of a Bubble CPAP device from $6,000 to $150. In the U.S. the device has reduced respiratory distress disorder mortality in infants from 75% to 20%. The innovation developed by two students involved substituting two aquarium pumps for the pumping mechanisms in the original device.
Another innovation involved development of low cost phototherapy lights to treat neonatal jaundice, which lowered the cost of the conventional device by two orders of magnitude. Another student developed a bright field and fluorescent microscope that allows image capture on an iPhone. The cost was about $250. Finally, students responded to a concern that children being given liquid antiretroviral therapy receive correct doses of the drugs. They developed a small "dosing clip" that could be inserted into the barrel of a syringe that would stop the plunger when it withdrew the correct dose from a drug vial. In the final product the clips are color-coded for different dose amounts.
Dr. Richards-Kortum commented that these low-cost innovations reach the market fairly quickly. A group in Swaziland ordered 200,000 clips for use in the scale-up of a national PMTCT program. A hospital in Malawi is using the clips in a late-stage cervical cancer program to insure accurate dosing of liquid morphine. In many African countries the limited availability of cyto-technologists and pathologists hampers early detection of cervical cancer. Botswana, with a population of 2 million, has two pathologists. In response, the Rice program developed a battery-powered microscope that can look at a tissue specimen without having to extract it, and complete the histological analysis. The fiber optic probe is small enough to fit into the biopsy channel of an endoscope. It provides real-time analysis. The technology can compete with conventional equipment, such as the Pentax confocal endoscope, that costs half a million dollars. Using the Rice device an iPhone can capture the same images.
Dr. Richards-Kortum commented that the Gates Foundation had funded a Grand Challenge Program for point-of-care diagnostics and a number of interested groups are looking at micro-fabrication and microelectronics to reduce the size and cost of currently available devices. She mentioned several challenges that should be addressed - making opportunities in the field visible to students as an incentive to consider careers in bioengineering; encouraging long-term research partnerships and helping researchers implement innovations; enable scale-up in low resource settings; and helping innovators move through the valley of death and into commercialization of effective products.
Dr. Glass invited Dr. Katz to briefly review Fogarty's partnerships with NIBIB. Dr. Katz described NIBIB's co-funding to FIC, which has been slightly less than $150,000 for the last two years. FIC funding to NIBIB was $5,000 in 2011 (FIRCA). She added that six medical student scholars and two fellows in the last Fellows and Scholars program were bioengineers.
Dr. Katz described several programs that provide opportunities in bioengineering. Fogarty intends to increase the number of bioengineers in the Fellows and Scholars program. The Framework Programs provide opportunities for pilot studies in both bioengineering and biomedical imaging. The GeoHealth program, focused on environmental and occupational health issues, involves personal health monitors and diagnostic and medical devices for pulmonary disease. The Lifespan program in Fogarty's non-communicable disease program includes the Madras Diabetes Research Foundation with which NIBIB is associated. There are medical devices in the Trauma program, and linked awards in MEPI. Fogarty is collaborating on mHealth initiatives and there are bioengineering opportunities there.
Dr. Glass invited comment. Dr. Black commented that, although the point-of-care diagnostics is important, there should also be consideration of population-based diagnostics for nutritional deficiencies, infectious diseases, and vaccine coverage. Dr. Merson noted that engineering schools tend to focus on patents and publications by faculty, and there is little emphasis on public health. He felt it would be appropriate to encourage a constituency in that area at engineering schools. Dr. Glass responded that the Framework program brings universities together to get multiple faculties involved with global health and, although bioengineers may participate, there could be a stronger effort to involve them. Dr. Pettigrew expressed concern that the engineering school faculty, and even the students, may not appreciate the NIH perspective that global health should be a part of the school's agenda in producing bioengineers. Regarding an earlier comment, Dr. Pettigrew stated that engineers are trained to meet design goals, and when the parameters are set for those goals they need to reflect the real world. Designing a three-dollar glucose test may be appropriate for the U.S., but totally out of the reach of the diabetic population in India. Dr. Richards-Kortum observed that engineering students are concerned about their careers, and what will get them tenure, grants and published papers. The medical research community must respond to those concerns.
Dr. Olopade observed that there was emphasis on bringing costs down - and there has to be a relationship between cost and quality - versus the demand in the U.S. for higher quality, faster service, which has driven costs up. There has to be a profit incentive for private industry to participate. Dr. Pettigrew responded that that was the reason that industry was invited to the table during the U.S.-India summit meeting. Industry must see the potential for profit to participate.
Dr. Barry commented that innovation is worthless unless those who should use the innovation accept it. Behavior change is key to integrating the innovation into public health use. She suggested that behavioral science might be an appropriate part of the grant process. She added that IP and regulatory affect was also an issue that might be included in training grants.
Dr. Richards-Kortum suggested that two gaps might be considered. First, limited resources might pay big dividends in developing opportunities for junior faculty in bioengineering if it could be designed to help their careers. Second, is to provide training for entrepreneurs who might take innovations into the marketplace and commercialize them in a way that would benefit low-resource settings.
Asked about mobile health initiatives, Dr. Pettigrew commented that the tremendous proliferation of mobile devices offers opportunities to reach out to communities and garner feedback on population-based issues. Enrolling large populations in studies would be possible with that kind of technology. Dr. Tierney described a program called home-based counseling and testing, using hand-held technology that allowed the screening of 700,000 and developed a database of information about their health status. However, it does take a systematic approach to manage the data.
Noting the time, Dr. Glass called the discussion to a close. He announced that the next meeting would be held on May 15th. He expressed appreciation to the Board members and to others who attended and participated in the meeting.
The meeting was adjourned at 3:00 p.m.