SUNDAY, JUNE 24, 2018

South African medical board continues to deny access to TB treatment

The South African Medicines Control Council intends to continue denying compassionate use or pre-approval access to a treatment for drug-resistant tuberculosis.

The MCC recently met to discuss whether or not bedaquiline should be made available on a conditional basis to patients with extensively drug-resistant TB before it is approved by regulatory authorities. The medicine is considered a final hope for many South African TB patients with limited options, according to

MCC spokesman Popo Maja would not reveal details about the meeting, but acknowledged the issue had been discussed.

"It is not normal practice for the MCC to divulge our client's information. The matter was on the agenda of MCC and the outcome has already been communicated to the applicant. We are awaiting for the client's response," Maja said, reports.

A South African medical activist group recently acknowledged that the MCC should not routinely make medicines available without proper testing, but, in this case believe bedaquiline should be accessible.

"Nevertheless, we believe the arguments for making bedaquiline available are compelling and outweigh the concerns," the activist's said, reports. "The MCC should be more open to considering compassionate access for people facing high morbidity or mortality due to failure of current best approved treatments. This is not a frequent situation. It no longer applies to diseases like HIV or diabetes for example. But it does apply to drug-resistant TB.

Bedaquiline is currently not licensed for use anywhere in the world, but it is being fast-tracked by regulatory bodies in the United States and Europe. The World Health Organization is supportive of compassionate access measures to the treatment.

Last year the MCC reversed its initial decision to grant compassionate access use to bedaquiline.