For the first time in more than 40 years, the Food and Drug Administration has approved a tuberculosis medicine that attacks the disease differently from drugs currently on the market. While this isn’t necessarily a big deal for most Americans, in poorer countries, this development can mean the difference between life and death. But at what cost?
The drug hasn’t been approved without some warnings from the FDA. Sirturo, which is the future brand name of the generic drug bedaquiline, must carry the black box warning because it can adversely affect the heart’s rhythm. It seems as if some tuberculosis patients and the doctors treating them are going to be put in a catch-22 situation. They will have to decide if treating the TB is worth risking damage to the heart that could prove to be fatal.
During the limited clinical trials for Sirturo, nine patients who were taking the drug died. Only two who were taking the placebo died. For this reason, the FDA is advising doctors to only use this new TB drug when other treatments haven’t worked for drug-resistant strains.
It is important to note that bedaquiline was approved under an accelerated program and is considered conditional. Johnson & Johnson, makers of Sirturo, will perform more clinical trials to determine how patients fare long-term after taking this drug. It is understandable that the FDA would want to help find new treatments for a disease that has been treated in the same way for a very long time, but it does seem like that is giving Johnson & Johnson the ability to use people who take the drug now as guinea pigs.
What do you think about this development in the war against TB? Should the FDA have approved this tuberculosis medicine despite the much higher death rate for those taking the drug as opposed to those taking the placebo?
Casey Holley is a freelance writer covering a plethora of topics. She enjoys writing articles about Christianity, medical developments, the American Bully world and crafts. You can follow her on Facebook, circle her on Google+ and read more of her work at Content by Casey.