Life-saving drug on hold

A drug with the potential to save the lives of drug-resistant TB suffers has been withheld until all clinical trials are completed.

Despite a request by non-government organisations for the drug to be made available for compassionate use, the Medicines Control Council has refused.

Bedaquiline, manufactured by international pharmaceuticals company Janssen Pharmaceutica, has the potential to save the lives of those suffering from the most drug-resistant form of TB, commonly known as XDR-TB.

The refusal, which has yet to be communicated to the non-government organisations requesting controlled access to the drug for limited numbers of extremely drug-resistant TB patients, was made earlier this month.

The requests were made by Médicins Sans Frontières and the Treatment Action Group, which want to use Bedaquiline on patients who have no other hope.

They want the drug made available for "compassionate use", which would allow countries to use drugs that are still being tested on critically ill patients.

But the council says it wants further clinical trials to be completed first.

"Though the motivation for the use of Bedaquiline is compelling, current available data are limited and premature," it said.

The Treatment Action Group has argued that "patients have died, and are dying and will continue to die, because current drugs are failing to cure [most] XDR-TB patients.

"Bedaquiline is the first TB drug in a new class to have been developed in 60 years."

Médicins Sans Frontières' advocacy officer, Mara Kardas-Nelson, said: "We're not trying to use Bedaquiline across the board but we want to use it for patients who have no other option."

The Treatment Action Group argued that the first phases of clinical trials showed that the drug was safe.

"The available scientific data and success of existing Bedaquiline compassionate-use programmes are more than sufficient to justify compassionate use in South Africa. Denying these patients access to Bedaquiline is, in many cases, a death sentence."

The council said it decided it could not allow Bedaquiline to be used before clinical trials had been completed because of concerns about its long-term effects and questions about how its use would be monitored.

It said it would be better to provide patients access to a drug through a "formal clinical trial".

Explaining how it would go about the clinical trials, the council said it would ask the Department of Health to submit a clinical trial protocol for review.

"The application will be attended to as a matter of urgency."

Kardas-Nelson said the council had at first told Médicins Sans Frontières it could use the drug on a compassionate basis - but told Janssen Pharmaceutica not to supply it.

Janssen medical director Abeda Williams said the company "had to abide by the council's ruling".