AZT (azidothymidine) holds the record for the fastest approval of a drug by the FDA (Food and Drug Administration) in a period of just 19 months. This was due to the fact that the AIDS epidemic was reaching a critical stage in the 80’s and the first clinical trial showed that patients who were taking the placebo were dying faster.
The need to treat patients simply outweighed the need for further testing and the political climate at the time put huge pressure on the FDA to fast track testing and accelerate approval. Protests from HIV/AIDS sufferers, their families and friends was part of the reason that the FDA needed to approve the drug for mass production very quickly.
AZT is a reverse transcriptase inhibitor which simply means that it prevents the production of DNA to lower the viral load in patients. It is not a cure but rather an effective treatment, allowing patients to live longer with the disease.
Since approval on March 19, 1987, there has been much controversy regarding the lack of testing. Side effects, contraindications and interactions that weren’t noticeable after the first trial started becoming evident.
This became an issue when the drug started being used to prevent mother to child transmissions of HIV/AIDS. Although the drug was very effective, it was also related to fetal abnormalities and birth defects.
Other prominent side effects that came under debate is that AZT killed healthy cells in the body and increased the symptoms of the disease. This was fatal in some patients, especially children.
Today, drug resistant strains of HIV have meant that new and improved treatments are available. The exorbitant cost of AZT treatment has also led to it going of patent in record time which means generics are now available at a more affordable cost.