Towards ending tuberculosis: what gets measured gets done
In 2008, WHO and UNAIDS introduced the “3 I’s” strategy for addressing the management of HIV/TB co-infection. Intensified case finding was the first prong of the strategy. Even in an era with widespread access to antiretroviral therapy, too many people living with HIV died because of undiagnosed TB co-infection. WHO recommended that all people living with HIV should be screened for their TB status with a clinical algorithm at each clinical encounter.
In the second prong of the strategy, WHO recommended that people infected with HIV, but proven to not have TB, should be given isoniazid preventive therapy for at least six months as part of a comprehensive package of HIV care. That recommendation was strengthened by evidence that the effects of isoniazid preventive therapy augmented the effects of antiretroviral therapy in reducing the incidence of TB. As people with HIV are exceptionally vulnerable to the risk of nosocomial TB transmission, the third prong set out measures for infection control that should be strictly implemented in all facilities providing HIV care.
In July 2011, WHO issued its first-ever negative policy recommendation to tackle diagnostic practices that were both dangerous for TB control and wasting resources in the millions of dollars. WHO urged countries to ban the use of inaccurate and unapproved commercial blood tests to diagnose active tuberculosis. Before making that recommendation, WHO meticulously gathered and verified compelling evidence that these serological tests were inconsistent, imprecise, and put patients’ lives at risk. The many false-positive results delivered by these tests meant that patients took toxic medicines for months, for no reason. False-negative results meant that people received no treatment and took no precautions to prevent infecting others, a particularly dangerous failure for an airborne disease that readily spreads via a cough or a sneeze.
"In July 2011, WHO issued its first-ever negative policy recommendation to tackle diagnostic practices that were both dangerous for TB control and wasting resources in the millions of dollars."
Dr Chan, WHO Director-General
WHO estimated that more than a million of these inaccurate blood tests were carried out each year, often at great costs to patients, who paid up to $30 per test. At that time, the marketing of blood tests for TB was targeted at countries with weak regulatory control of diagnostics, where perverse market incentives were allowed to override the welfare of patients. In short, a multimillion dollar business was selling substandard tests with unreliable results.
That negative policy recommendation had a rapid and welcome impact. In June 2012, India’s Ministry of Health and Family Welfare banned the manufacture, sale, distribution and use of the tests throughout the country. The government decree directly attributed that decision to a “negative policy statement issued by WHO that commercial serodiagnostic tests provide inconsistent and imprecise findings.”