Statement of Christine F. Sizemore, Ph.D., Barbara
E. Laughon, Ph.D., and Anthony S. Fauci, M.D., National Institute
of Allergy and Infectious Diseases, National Institutes of Health
on World TB Day, March 24, 2008
As we commemorate World TB Day, we recognize the important strides
made in combating tuberculosis (TB) over the past several years,
and, simultaneously, are reminded of the substantial challenges
that lie ahead.
Nearly one-third of the world's population is infected with Mycobacterium
tuberculosis (Mtb), the bacterium that causes TB, and more
than 14 million people are afflicted with TB disease, with high-burden
countries showing a continued increase in the number of patients
diagnosed. In 2006, an estimated 9.2 million new cases of TB
emerged, of which approximately 700,000 occurred among individuals
also infected with HIV. The same year, an estimated 1.7 million
people died of TB, including 200,000 patients co-infected with
HIV.
Recently, the World Health Organization (WHO) reported that the
incidence of multidrug-resistant TB cases is on the rise. Among
new cases of TB, an estimated 5 percent, or 500,000 annually, are
multidrug resistant (MDR), with resistance to at least the first-line
TB drugs isoniazid and rifampin. An estimated 10 percent of all
MDR TB cases are extensively drug resistant (XDR); they do not
respond to therapy with the most effective anti-TB drugs. The spread
of drug-resistant Mtb strains to HIV-infected people poses
significant challenges in countries with high rates of TB and HIV
infection and threatens to reverse gains made in the control of
these diseases.
Controlling the spread of TB and slowing the development of drug-resistant Mtb strains
requires an integrative approach. NIAID works with domestic and
international partners to support basic, translational and clinical
research that helps us better understand TB and develop new diagnostics,
treatments and prevention tools. In 2007, the Institute released
the NIAID Research Agenda: Multidrug-Resistant and Extensively
Drug-Resistant Tuberculosis, which identifies research priorities
in TB-related areas. The agenda also highlights the importance
of fostering partnerships with public and private organizations
to fuel the pipeline of available drugs, diagnostics, and preventive
measures for TB.
Domestically, NIAID coordinates its work on TB with other NIH
Institutes and Centers, the U.S. Centers for Disease Control and
Prevention (CDC), the U.S. Agency for International Development
(USAID) and other federal agencies. These interactions are facilitated
through the Federal TB Task Force and the NIAID-CDC Joint Partnership
Implementing TB Elimination Research. In addition, NIAID coordinates
efforts with for-profit and not-for-profit agencies, as well as
public-private partnerships. Internationally, through the Stop
TB Partnership, NIAID collaborates closely with organizations that
conduct and monitor disease and drug resistance surveillance, provide
clinical care for TB patients (with and without concomitant HIV
infection), and support research training and TB control programs
throughout the world. Such partnerships must be strengthened — and
new opportunities pursued — as we work to bolster efforts
to control TB and halt the spread of drug-resistant Mtb.
Because of the profound effect of HIV co-infection on the course
of TB and vice versa, we must better integrate the diagnosis, care
and treatment of people who have HIV/AIDS, TB and other diseases.
We are working to develop improved diagnostics that would allow
HIV-infected people to be rapidly tested for Mtb — and
for TB patients to be tested for HIV infection — so that
appropriate treatment can be initiated as soon as possible. We
also are working to better understand which TB drugs work most
safely and effectively in HIV-infected individuals, particularly
those receiving antiretroviral therapy. In addition, we are developing
new, faster-acting anti-TB therapies.
Ultimately, controlling TB depends on effective prevention strategies,
especially vaccines, and TB vaccine development is a critical goal
of the NIAID research agenda. An ideal vaccine would be safe and
efficacious for everyone, including those infected with HIV.
As partnerships for creating new drugs, vaccines and diagnostics
are established, we continue to work with our partners to better
understand the needs of TB-endemic countries and to assure that
diagnostic, therapeutic and preventative tools that have been developed
in wealthy countries are affordable and practical in resource-limited
settings. We are working to improve communication among basic research
scientists, manufacturers and clinical care providers so that the
development of efficacious and appropriate intervention tools and
strategies is guaranteed from the earliest stages of research.
Many important TB research programs are bearing fruit. For example,
researchers from the United States and South Africa recently determined
that little variation exists between the genomes of MDR- and XDR-TB
strains. This study and others like it contribute to an understanding
of factors contributing to drug resistance and provide new leads
for diagnosing and treating drug-resistant forms of TB. SQ109,
an anti-TB drug candidate developed through a partnership between
NIAID and Sequella, Inc. was recently granted orphan drug status
by the U.S. Food and Drug Administration and the European Medicines
Agency for potential use against drug-susceptible and drug-resistant
TB. NIAID has assisted in the preclinical development of another
candidate drug, PA-824, currently in Phase II clinical trials sponsored
by the nonprofit Global Alliance for TB Drug Development. In addition,
NIAID recently formed a partnership with the Eli Lilly Foundation,
the Infectious Disease Research Institute of Seattle, and others
to further stimulate TB drug discovery. This effort is called the
Lilly Not-for-Profit Partnership for TB Early Phase Drug Discovery
[http://www3.niaid.nih.gov/topics/tuberculosis/Research/lilly.htm.].
Although significant progress has been made, much remains to be
done. NIAID is working to better integrate individual resources
to create efficient pathways that will rapidly lead to candidate
drugs, diagnostics and vaccines. The most promising of these will
be assessed in clinical trials of the highest quality.
Combating TB requires cooperation by scientists, manufacturers,
funders, policy-makers, advocates, and, ultimately, health care
providers and patients to work together on new approaches to this
devastating disease. As we commemorate World TB Day this year,
we commend the efforts of scientists, clinicians and volunteers
who work tirelessly to contain the spread of TB and to improve
the health of TB patients throughout the world, and hope that more
individuals will join this most important global health endeavor.
For more information about TB, visit http://www3.niaid.nih.gov/topics/tuberculosis/default.htm and http://www.hhs.gov/tb/.
Anthony S. Fauci, M.D., is director of the National Institute
of Allergy and Infectious Diseases (NIAID) at the National
Institutes of Health. Christine F. Sizemore, Ph.D., is chief
of the Tuberculosis and other Mycobacterial Diseases Section
in the NIAID Division of Microbiology and Infectious Diseases. Barbara
E. Laughon, Ph.D., is the senior scientist for TB drug development
partnerships in the NIAID Division of Microbiology and Infectious
Diseases.
Media inquiries can be directed to the NIAID Office of
Communications at 301-402-1663, niaidnews@niaid.nih.gov.
NIAID is a component of the National Institutes of Health. NIAID
supports basic and applied research to prevent, diagnose and treat
infectious diseases such as HIV/AIDS and other sexually transmitted
infections, influenza, tuberculosis, malaria and illness from potential
agents of bioterrorism. NIAID also supports research on basic immunology,
transplantation and immune-related disorders, including autoimmune
diseases, asthma and allergies.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.
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