Breath of Hope: TB in Africa - Pharmaceutical Executive


Breath of Hope: TB in Africa
For the first time in decades, pharma has tuberculosis drugs in the pipeline. But it will take more than new pills to solve the problem. Executive Editor Joanna Breitstein reports from East Africa.

Pharmaceutical Executive

"Trials that change one drug for another take four to six years for the first trial to be approved," says Freire. "Then you drop the second drug, which takes another six years. By the time you replace the four drugs, you're into 24, 30 years. We can't do that, but the question remains: How do you conduct very solid, ethical, and well-controlled trials that have different arms in which you substitute more than one drug at a time?"

As industry begins to iron out these issues, another challenge looms: the gap between registration and adoption of policy, says Tom Kanyok, PharmD, manager of product development for WHO's tropical diseases program. For example, most patients in Tanzania take the eight-month DOTS regimen, but studies show the shorter, six-month regimen (with the continuation therapy of rifampicin and isoniazid) was more effective. However, many countries are still "using up the drugs they have" before moving to the six-month regimen, according to one government source.

These issues seem like a lot for industry to sort out, but companies do gain in return. "If you deal proactively with issues, you have lower reputational, legal, and financial risks," says Leisinger. "I want 85,000 ambassadors working for Novartis going out and saying 'Hey, we are doing great things, I'm so proud of it!' We will have less fluctuations, and more motivated people."

Novartis' Matter says other lessons will be more direct. "Neglected-disease research allows us to experiment with new models of discovery. We learn how to do things with less money. If we find ways to decrease the attrition, we will have learned something that's valuable for the whole industry."

Meanwhile, Nurse Ochogo is learning her own lessons. One of her patients, a young man waiting his turn at Temeke Hospital, is back. He completed a few months of DOTS a while ago. But when he started to feel better, he stopped coming. Soon he grew sick, lost weight. Next, the incessant cough started, accompanied by the bloody sputum. Now he's back in treatment, but his old drugs don't work anymore.

Nurse Ochogo has seen it before. She needs time for these returning patients and is speeding up her morning DOTS reveille. She used to see patients individually. Today, she calls them three at a time.


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