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Mitochondrial replacement techniques (MRTs) are designed to prevent
the transmission of mitochondrial DNA (mtDNA) diseases from mother
to child. While MRTs, if effective, could satisfy a desire of women
seeking to have a genetically related child without the risk of
passing on mtDNA disease, the technique raises significant ethical
and social issues. It would create offspring who have genetic
material from two women, something never sanctioned in humans, and
would create mitochondrial changes that could be heritable (in
female offspring), and therefore passed on in perpetuity. The
manipulation would be performed on eggs or embryos, would affect
every cell of the resulting individual, and once carried out this
genetic manipulation is not reversible. Mitochondrial Replacement
Techniques considers the implications of manipulating mitochondrial
content both in children born to women as a result of participating
in these studies and in descendants of any female offspring. This
study examines the ethical and social issues related to MRTs,
outlines principles that would provide a framework and foundation
for oversight of MRTs, and develops recommendations to inform the
Food and Drug Administration's consideration of investigational new
drug applications. Table of Contents Front Matter Summary 1
Introduction 2 Science and Policy Context 3 Do Ethical, Social, and
Policy Considerations Preclude MRT? 4 Regulation and Oversight of
MRT in Humans Appendix A: Study Approach Appendix B: Summary of MRT
Research Appendix C: Biosketches of Committee Members
Tuberculosis (TB) kills approximately 4,500 people worldwide every
day. While most cases of TB can be treated with antibiotics, some
strains have developed drug resistance that makes their treatment
more expensive, more toxic and less effective for the patient. The
IOM Forum on Drug Discovery, Development, and Translation and the
Academy of Science of South Africa held a workshop to discuss ways
to fight the growing threat of drug-resistant TB. Table of Contents
Front Matter 1 Introduction 2 The Incidence of Drug-Resistant TB in
Southern Africa 3 Surveillance and Tracking of Drug-Resistant TB 4
Transmission and Infection Control 5 Diagnosis of Drug-Resistant TB
6 Treatment of Drug-Resistant TB 7 Drug-Resistant TB in Children 8
Convergence of Science and Policy to Create a Blueprint for Action
References Appendix A: Agenda Appendix B: Report from the National
Institute of Allergy and Infectious Diseases (NIAID) Workshop
Appendix C: Participant Biographies
The Food and Drug Administration (FDA) is tasked with ensuring the
safety and effectiveness of medicine. FDA's science base must be
strong enough to make certain that regulatory decisions are based
on the best scientific evidence. The IOM held a public workshop on
February 26, 2010, to examine the state of regulatory science and
to consider approaches for enhancing it.
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