Children, people with HIV, pregnant women and others underserved by TB drug development present ethical imperative, opportunities for global disease approaches, authors say

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Populations with needs that can and do affect the impacts of tuberculosis treatments are among the most vulnerable to the disease, make up significant proportions of the total of people sick with the disease worldwide, but are also the most neglected in TB drug development efforts. An article in a recently released Journal of Infectious Diseases supplement on tuberculosis drug development explores the challenges that developing products of appropriate doses and formulations for children, people with HIV, people with diabetes and pregnant women as well as the opportunities that meeting those challenges present.

Consider infants, who face the highest risks, particularly if coinfected with HIV, of tuberculosis infection progressing to disease that poses threats of permanent damage, transmission and death. And yet fifty years after the development of the first drugs to cure tuberculosis, those drugs fail the majority of children, authors of the article note. Ethical dilemmas surrounding the inclusion of children in clinical trials are among the reasons for that neglect, but lately the recognition has arisen that administering drugs to children that have not been proven effective or appropriate for children is unethical too. The results of drugs not tailored to children have included guesswork and improvisation that lead to unpalatable, inadequate, and toxic doses that in turn lead to incomplete treatment. Existing data from studies on medicines for adults can factor into knowledge that pediatric specialists can offer, the authors say, noting that the multi-disciplinary collaboration could offer a model to other approaches to global disease.

And while clinical trial data on the safety and effectiveness of tuberculosis drugs for pregnant women is similarly limited, the authors note that existing data provides information on the safety and effectiveness of some drugs with pregnancy, and high-incidence settings have offered the opportunity to collect data on outcomes when pregnant women have already received drugs. While people living with HIV, who make up an estimated 12 to 13 percent of people getting sick with TB annually, and more than half of those diagnosed with tuberculosis in southern Africa, also face greater threats from tuberculosis infection, disease and drug interactions, the need for medicines safe for people with the virus, with compromised immune systems and compatible with antiretroviral treatment remains critical. Improved support for clinical monitoring in areas with high burdens of both diseases would yield valuable data, though, the authors say. People with diabetes also face greatly increased risks of getting sick with tuberculosis, as well as of health impacts from tuberculosis treatment. With the number of people diagnosed with diabetes having more than doubled in the first decade and a half of this century, and projected to continue to increase in developing countries, the authors point out, the need to meet their needs only grows more pressing.

Recognition of all of those needs is the first step, the authors note, emphasizing that to meet them, sustainable research systems in countries most heavily hit by tuberculosis will be essential.

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