At a conference focused on “Accelerating toward elimination” attention turns again to stalled rollouts of the most promising medicines and regimens
GUADALAJARA, Mexico – A tuberculosis survivor from India whose treatment spanned six years asked “Now that there is an alternative, why are we refusing to use these drugs?”
A South Africa TB survivor explained how if the newest drugs had been made available in time to reach her, she would not have lost her hearing — a side-effect of the older more toxic drug that doctors used to save her life.
A physician-researcher in Mexico described how ill-equipped labs have stalled implementation of the World Health Organization-recommended short course treatment for TB, while high drug prices block access to the new medicines in a middle income country.
A physician from India described how bureaucratic hurdles and requirements for drug resistance testing left 65 courses of bedaquiline treatment unused at a Mumbai hospital while a modeling study showed that using the medicine would have boosted cure rates for patients from 44 percent to 62 percent. The hospital is one of the most experienced at treating TB patients in the world, the physician noted, but still needs to obtain individual approval for each patient treated with bedaquiline.
And presenters from the EndTB project, a UNITAID-funded, Partners in Health, Medecins Sans Frontieres, Interactive Research and Development collaboration to lay the groundwork for the use of optimal treatments in challenged settings showed again and again that the newest drugs could be safely and effectively provided and tracked across diverse communities where they are needed most. Their stories, however, remain the exception, rather than the rule, in the absence of broad-based strategies and agreements to make the newest drugs routinely accessible to patients who would benefit from them, speakers at sessions across the four days in Guadalajara said.
In the meantime, while the drugs are new to national tuberculosis programs, and offer new hope to the scattered patients receiving them, they’ve been around for years, Erica Lessem of Treatment Action Group noted, “five years for bedaquiline.”
That drug, from Janssen pharmaceuticals, became the first new anti-tuberculosis drug to receive regulatory approval in nearly half a century when the U.S. Food and Drug Administration okayed its use for patients with drug-resistant TB in 2012.
Lessem wore a T-shirt asking: “WHERE ON EARTH IS DELAMANID?”
That drug, from the Japanese Otsuka pharmaceutical company had advanced further in clinical trials than bedaquiline in 2012, but did not receive regulatory approval until 2014. Both drugs remain out of reach for the vast majority of patients for whom they represent a last resort.
Companies not making the drugs sufficiently affordable or accessible, and governments not making the funding to qualify for and purchase the medicines are two of the problems, Lessem said.
And she noted, after the Mumbai physician’s account, practices must be geared toward access rather than restriction.
“Throwing away expired stock is really a crime,” she observed.