TB partners, patients ask: How does a bacterium responsible for nearly a third of drug-resistance deaths not make list of R&D priority pathogens?
Exclusion of tuberculosis from WHO “catalogue of 12 bacteria that pose the greatest threat to human health,” threatens development of medicines to treat world’s leading infectious disease killer, health advocates and leaders say
While the unveiling of a list highlighting the need to fund drug development against specific pathogens represented just a beginning for some antimicrobial resistance fighting efforts, the list represented a setback for TB drug development, advocates say
The day after the World Health Organization released its “first ever” list of drug-resistant bacteria for which new medicines are the most urgently needed, the agency released a second announcement on the topic Tuesday, emphasizing its recognition of drug-resistant tuberculosis, which had been left off the list, as “a top priority for WHO and for the world.”
At Johns Hopkins Center for Tuberculosis Research, Dr. Richard Chaisson called the clarification “very welcome.”
The last came from the International Union Against Tuberculosis and Lung Disease which issued the demand on Tuesday, and reiterated it today in a letter to WHO Director General Margaret Chan saying that “WHO must revise the list to include TB with immediate effect.” The omission of tuberculosis from a list that WHO released with the stated purpose of influencing the direction of funding for pharmaceutical research to areas demanding the most urgent attention, “could have tangible, harmful effects on TB research,” the letter asserts.
In responses to the exclusion of the bacteria that causes tuberculosis disease from the WHO list of “priority pathogens” requiring precedence in new new drug development, the Union, TB Alliance and the Stop TB Partnership all highlighted impacts of the disease that in 2015 included an estimated 1.8 million deaths, among them the deaths of more than 200,000 children, and more than half a million people stricken with drug-resistant TB, with only 11 percent cured. The TB advocacy organizations’ responses also noted declines in the funding that have led to a $2.4 billion dollar gap between what is needed, and what is available to develop new TB treatments. In addition, the responses cited findings of the UK Review on Antimicrobial Resistance, released in May 2016, which predicted that drug-resistance could take 10 million lives a year by 2050, with a quarter of those lives lost to tuberculosis, and which called tuberculosis “a cornerstone of the AMR [antimicrobial resistance] challenge.” WHO officials had cited the review as having guided development of the list during their press conference Monday without noting those points.
The Monday WHO announcement of the list had explained that tuberculosis was not included on the list “because it is targeted by other, dedicated and well-funded programmes.”
The Stop TB Partnership, which responded Monday to WHO’s announcement of the list with a statement that tuberculosis program leaders, researchers, donors, advocates, and affected people were dismayed as well as “surprised and appalled” by the exclusion of tuberculosis, called the first explanation inaccurate with “significant implications for the manner in which we will fight TB and drug resistant TB” and noting “widely acknowledged” gaps in research for tuberculosis treatment. Similarly, a statement from TB Alliance urging WHO to add tuberculosis to the list calls research to develop new TB treatments “chronically underfunded despite the disease’s impact.”
WHO Assistant Director-General Dr. Marie-Paule Kieny had offered a subsequent explanation for the omission during a press conference, that the pathogen was left off the list because “there is already consensus that tuberculosis is the most important priority for research and development of new antibiotics.” In its letter to Dr. Chan today, the Union calls this explanation, which WHO repeated in its statement Tuesday, “outrageous,” adding that it “defies reason.”
“The WHO has previously identified M. tuberculosis as a very high priority organism for drug development due to widespread drug resistance,” Dr. Chaisson of Johns Hopkins said. “Yet it is unfortunate that it was left off the list of priority organisms for drug development, as the orphan status of TB has been more of a hindrance than benefit for many years, and antimicrobial development programs need to incorporate the full spectrum of drug resistance that threatens human health.”