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A promising new drug currently on trial offers the last hope for some patients with pre-extensively drug resistant (XDR) or XDR tuberculosis, and the life or death decision on whether to make it available rests with the Medicines Control Council (MCC).
In a letter sent last week to the MCC and health minister Dr Aaron Motsoaledi, Medecins Sans Frontieres (Doctors without Borders) and almost 50 doctors and scientists have urged the regulatory body to urgently consider the compassionate use of TMC207, a novel drug currently in Phase III trials.
Compassionate use allows for the dispensing of investigational drugs before they are registered and enter the market.
MSF and other organisations around the world have attempted to use TMC207 for a select few patients with pre-XDR and XDR TB. For many of these patients there is no other hope and TMC207 offers a last chance of survival.
Serious XDR-TB in SA
According to MSF it did receive approval from the MCC in August last year to use the drug on compassionate grounds, but Janssen Infectious Diseases (formerly Tibotec) was verbally informed by the MCC to not give MSF TMC207.
MSF and others are now asking the MCC to explain.
South Africa has a serious epidemic of drug resistant (DR) TB. Every year about 10 000 people are diagnosed with multi-drug resistant (MDR) TB, with a substantial proportion suffering XDR TB.
Under the best circumstances, treatment with current, mostly very old drugs is only successful for around 60% of MDR TB and 44% of XDR TB patients.
MSF’s Dr Gilles van Cutsem said it was important to debunk the misguided belief that these patients developed DR TB through delinquency or non-compliance with treatment.
Patients infected directly
“Many of these patients were infected directly, through transmission of an already DR TB strain, and have been highly compliant with treatment,” said Van Cutsem.
TMC207 is a drug that represents the first new class of TB drugs to be developed in 60 years.
The letter urges the MCC to reverse the apparent decision to deny access to the drug and to confirm the compassionate use of TMC207.
“If the MCC has indeed withdrawn its approval for compassionate use and refuses to reconsider its decision, we then call on them to provide written justification for its actions which have denied potentially life-saving treatment to these patients,” the letter stated.
The MCC has been given until next Wednesday to approve the drug for compassionate use.
Neither the MCC nor the minister’s spokesperson could be reached for comment.
(Anso Thom, Health-e news, April 2012)
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