Washington, DC — Phase 2 Trials Showed Alarmingly Increased Risk of Death
U.S. Food and Drug Administration (FDA) officials should not approve the anti-tuberculosis drug bedaquiline, because clinical trials showed the drug could be highly dangerous, Public Citizen said today in a letter to the agency.
In the letter, Public Citizen said it strongly opposes the accelerated approval of bedaquiline because patients taking the drug in addition to standard TB treatment during a phase 2 clinical trial were five times likelier to die than those who took a placebo.
“In the face of clinical evidence of increased deaths, including deaths from TB or TB-related causes in patients getting bedaquiline, compared to those getting a placebo, it is not possible to give accelerated approval to the drug,” the letter stated.
In light of the increased possibility for death and the need to deny accelerated approval, Public Citizen said the FDA should consider if future phase 3 trials would be ethical and urged the FDA to confirm the following:
- All institutional review boards (IRBs) that are reviewing the phase 3 trial plans have been provided with the mortality data from the phase 2 trial and have assessed if the risks of the research outweigh the potential benefits;
- All subjects already enrolled in the phase 3 trial have been informed of the mortality data from the phase 2 trial; and
- The IRB-approved informed consent documents for the phase 3 trial clearly describe the mortality data from the phase 2 trial.
The letter also criticized the FDA for even considering the drug for approval at this stage of testing. The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval. But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug, a common question in new drug classes, even though it has admitted that the drug could be the culprit.