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No. 3, 2011

Dear Colleague:

We note with sadness the passing of four persons who made contributions to TB control. Tina Schein, who served as a TB public health nurse for many years, including 33 years in DTBE, died on July 2, and Dan Reyna, who served as the Director of the Border Health Commission, on July 29. Dr. John Sbarbaro, a world-renowned expert in TB control, passed away August 30. Marilyn Hansen, who contributed to TB control through her important work with the American Thoracic Society, passed away earlier this year; she was responsible for the original development of the Core Curriculum on Tuberculosis: What the Clinician Should Know (Core Curriculum). Please see the items on their lives and contributions in this issue of TB Notes.

This provides a segue to the next news: staff of the Communications, Education, and Behavioral Studies Branch (CEBSB) have been working for some time on the latest revision of the Core Curriculum. As this important document was last released in 2000, an update was in order. It will be available soon in print format, in limited quantities, and is available now online. An accompanying slide set is also available. This issue of TB Notes includes an article about the development of the Core Curriculum.

The first meeting of 2011 of the Advisory Council for the Elimination of Tuberculosis (ACET) was held June 7-8 here in Atlanta. Hazel Dean, ScD, MPH, Deputy Director, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), served as the ACET designated federal official. The first presenter was Rima Khabbaz, MD, Director, Office of Infectious Diseases, CDC. Dr. Khabbaz reported that CDC’s FY2011 budget reflects a reduction of 11% below the FY2010 budget. A summary of CDC’s budget is available at http://www.cdc.gov/fmo/. Despite these extensive budget cuts, CDC is committed to maximizing public health impact, maintaining the focus on national priorities, and sustaining critical programs.

After Dr. Dean gave the NCHHSTP Deputy Director’s report, I provided the DTBE Director’s report. For the benefit of the new members, I explained that these reports typically provide brief updates on recent activities conducted by DTBE and its branches.  However, this report would focus on DTBE’s challenge to ACET, “How should the national tuberculosis program (NTP) be configured to accomplish its elimination goal?”

To provide background, I outlined DTBE’s past strategies for TB elimination, including the 1989 strategic plan to eliminate TB from the United States, the 2000 Institute of Medicine report Ending Neglect, and the 2010 TB Elimination Plan from Stop TB USA. The 1989 strategic plan had established a TB elimination goal of ≤1 TB case per million population by 2010, but this goal was not met. In 2010, Stop TB USA estimated that eliminating TB by 2035 would result in 253,000 fewer TB cases, 15,200 fewer TB-related deaths, and a $1.3 billion reduction in TB treatment costs (in 2006 dollars). After explaining the challenges and opportunities for the national TB program, I charged ACET with revising and updating the TB elimination targets and measures of success for FY2011 and FY2012.

José Becerra, MD, MPH, Chief, Data Management and Statistics Branch, DTBE, used DTBE recent modeling data to report on U.S. TB trends. The U.S. annual percentage rate change of TB incidence decreased from 7.3% in 2000 to 3.8% in 2008. Given a continued 3.8% percentage change, it would take 100 years to achieve the TB elimination goal of 1 case per 1 million persons.  To eliminate TB by 2050, we would need a percentage change of 8.8% plus new diagnostic tools, new and shorter treatment, and a new TB vaccine. Dr. Becerra concluded by asking ACET to provide advice on three key questions: Is a TB elimination target date of 2050 feasible and realistic?  Should we consider incidence targets other than 1 case per million for different subgroups (e.g., U.S.-born versus foreign-born persons)?  Finally, should we set interim goals, now that we are able to detect TB clusters and recent transmission?

Next, Terence Chorba, MD, MPH, DSc, Chief, Field Services and Evaluation Branch, DTBE, reported on CDC’s cooperative agreements (CoAgs) and the National TB Indicators Project (NTIP). DTBE uses CoAgs to allocate categorical funding to 68 U.S. TB programs and four Regional Training and Medical Consultation Centers (RTMCCs). He noted the most significant challenges in national TB program capacity: the erosion of federal and state TB budgets, losses in human resources and proficiency, a smaller workforce of private providers and public health staff, and fiscal constraints. He then discussed the National TB Indicators Project (NTIP), a web-based performance monitoring system based on existing data sources. Indicator reports reflect progress toward national objectives in 15 high-priority categories; focus program evaluation efforts; and provide performance targets as benchmarks for assessment. 

Wanda Walton, PhD, Chief, Communications, Education, and Behavioral Studies Branch, DTBE, reported on the four CDC-funded RTMCCs: the New Jersey Medical School Global TB Institute, the Southeastern National TB Center, the Heartland National TB Center, and the Curry International TB Center. Since 2005, RTMCCs have provided >4,400 hours of training to 44,484 participants with in-person or web-based formats, 152 mini-fellowships, and 12,619 medical consultations.  They also develop educational products for both regional and national audiences.  The products are accessible in various formats and are available free of charge whenever possible.  The RTMCC Products Page provides access to 164 TB products and archived webinars. Dr. Walton asked ACET to help CDC clearly define the future role of RTMCCs in light of funding constraints.

Thomas Navin, MD, Chief, Surveillance, Epidemiology, and Outbreak Investigations Branch, DTBE, reported on recent scientific advances that will support early outbreak detection.  The first advance is genotyping, which allows for the identification of genetically related organisms, which in turn allows the identification of genotype clusters of TB cases. The second development is the linkage between genotyping data and surveillance data; as of March 2011, the TB Genotyping Information Management System (TB GIMS) contained >55,000 patient records with genotype and surveillance results.  The third advance is the use of genotype and surveillance data to predict, detect, and analyze TB outbreaks. DTBE tested a future outbreak detection algorithm by using TB GIMS data from an actual outbreak in a homeless shelter; the local TB program noted the problem in 2009 after case 7, but TB GIMS would have signaled an alert in 2008 after case 3. Several principles will guide DTBE’s updated TB outbreak response plan:  Actions will be in line with CDC’s core values of accountability, respect, and integrity; DTBE will acknowledge its role as a guest of host jurisdictions; collaborations will be fostered and expertise will be built within and outside of CDC; and surge capacity will be provided when requested.

Bonnie Plikaytis, MS, Deputy Chief, Laboratory Branch, DTBE, reported on her branch’s activities. DTBE has identified several laboratory mandates for NTP: accurate, reliable, and prompt TB services must be provided; laboratory services must be coordinated with private providers and public health staff caring for TB patients; policy guidance must be available to help TB control staff make prompt, informed case management decisions and eliminate transmission of TB disease; and new tools must be developed. Current challenges include existing regulations that add complexity in terms of providing services in certain areas.  Also, laboratory infrastructure and logistics can be expensive, particularly the requirement to maintain a BSL-3 facility in each TB laboratory and the need to transport specimens to public health laboratories; the laboratory network depends on rapid referral of specimens and timely requests from local laboratories and providers. Ms. Plikaytis noted that elimination of funding for lab services would in some cases result in a disruption of services, and stated that data-driven guidance is needed in regard to funding and organization of public health laboratories.

I presented an update on behalf of Dr. Eugene McCray, Chief of the DTBE International Research and Programs Branch. CDC follows the “2011-2015 Global Plan to Stop TB” that was developed and published by the Global Stop TB Partnership. In addition, I represent CDC on the Federal TB Task Force’s U.S. Government Workgroup to Address Global TB, the Global Stop TB Partnership Coordinating Board, and the WHO TB Technical Advisory Group. I noted that Dr. Frieden is interested in CDC developing a unified policy to address global TB and has designated a TB Coordinator to make recommendations on investing resources in CDC’s global TB agenda; Dr. Harold Jaffe has been appointed the Acting CDC Global TB Coordinator. At the division level, DTBE collaborates with partners to reduce the importation of TB from other countries and also to address HIV-associated TB in sub-Saharan Africa.  DTBE also provide operational research training, and with resources from its global partners, deploys CDC staff to China, India, Kenya, and Thailand.  DTBE also provides technical support to implement infection control precautions and improve capacity in this area at the global level. Overall, CDC is interested in aligning its domestic and global TB activities for mutual benefit and welcomes guidance from ACET in achieving this goal.

Elsa Villarino, MD, MPH, Tuberculosis Trials Consortium Project Officer, DTBE, presented an update on CDC’s TB research conducted by the Tuberculosis Trials Consortium (TBTC). TBTC was initially funded in 1993 to conduct one trial and was formally reorganized in 1997; funding was renewed in 2009 for a 10-year period and will decrease by 22% in 2011. TBTC has made several notable accomplishments to date.  Its 9 major clinical trials and 15 sub-studies have enrolled >12,000 patients and volunteers.  Its studies have resulted in 25 publications in peer-reviewed journals and >100 presentations, posters, and abstracts at national and international conferences.  Nature Medicine cited TBTC Study 27 as one of the 20 most important TB papers published in the past 3 years. Dr. Villarino concluded that investments in TB research should be continued and strengthened so that these research advances can continue.

Thomas Navin, MD, Chief, Surveillance, Epidemiology and Outbreak Investigations Branch, DTBE, presented an update on CDC’s other TB research initiatives.  One research area is the Tuberculosis Epidemiologic Studies Consortium (TBESC).  The first 10-year cycle of TBESC was recently completed; of the 32 studies conducted, 2 were cancelled and 30 completed data collection by September 2011. TBESC will focus on LTBI in its next 10-year cycle, with its major study being a prospective comparison of tuberculin skin tests (TSTs) and interferon gamma release assays (IGRAs) in detecting LTBI and predicting progression from LTBI to TB disease. The second research area is NHANES.  DTBE and CDC’s National Center for Health Statistics signed an agreement in August 2010 to utilize NHANES data for TB research for the period January 2011 to December 2012.  DTBE incorporated 10 TB questions into NHANES and added TST and IGRA questions to the laboratory portion of the survey. The third research area is laboratory research. Studies seeking more accurate and rapid ways to detect TB drug resistance account for 50% of lab research. DTBE is also conducting research to improve genotyping. As the field of DNA sequencing continues to evolve and provide alternative approaches to genotyping, there will continue to be a critical need for operational research and for data analysis and interpretation.

Philip LoBue, MD, FACP, FCCP, Associate Director for Science, DTBE, discussed the development of evidence-based TB guidelines. He noted that ACET’s role in TB guidelines has ranged across a spectrum including no involvement, endorsing a product solely developed by CDC, actively participating in and endorsing a product developed by CDC, and developing and endorsing a product via a joint CDC/ACET workgroup. In addition, no criteria have been clearly defined as to which entities should develop TB guidelines.  Historically, professional societies have led the development of clinically based guidelines; the development of other guidelines appears to be based on legacy. DTBE’s methodology for evaluating evidence and grading recommendations is also variable and does not use a standardized system. Dr. LoBue asked ACET to provide advice to DTBE during a future meeting on important issues that should be addressed in the development of evidence-based TB recommendations and guidelines.

Stuart Berman, MD, ScM, presented an update on NCHHSTP’s recent activities related to prevention through healthcare. TB, HIV, STDs, and viral hepatitis account for substantial healthcare spending. Thus, anticipated U.S. health reform may allow advancement of NCHHSTP priorities. Dr. Berman noted an NCHHSTP consultation set for June 20-21, 2011, in Atlanta. The impact of changes in the healthcare system on service delivery were to be discussed.  We will share the implications of these changes for state and local health departments related to TB prevention as they become available.

Ann Cronin, Associate Director for Policy and Issues Management, DTBE, noted that many TB programs do not take advantage of the Omnibus Budget Reconciliation Act of 1993 that expands eligibility of services to TB patients. Congress enacted the legislation during the TB resurgence to eliminate all barriers to TB treatment. In states where the TB option is implemented, TB programs can bill Medicaid for prescribed drugs; case management and other services to encourage completion of therapy, including DOT services; and physician, x-ray, laboratory, and clinical services. The law excludes room and board of TB patients. Only nine states are implementing the TB option. CDC hopes to collect solid data and demonstrate the cost benefits of implementing the TB option.

At the business session, ACET discussed and made formal actions on a number of issues. The next ACET meeting will be held in early December 2011.

As I reported in the last TB Notes Dear Colleague letter, DTBE and colleagues in TB control gathered in Atlanta in June for the 2011 National TB Conference. In this issue we have the winners of the National TB Controllers Association (NTCA) poster competition, as well as winners of the second annual special awards for Exemplary Performance and Service in TB Prevention and Control. These awards provide an opportunity for us to recognize some of the amazing and dedicated individuals working among us in TB prevention and control. I hope you will take a look and read about their impressive accomplishments.

Kenneth G. Castro, MD

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