FDA approves untested drug for sale
January 1, 2013 in Health
The Food and Drug Administration circumvented its own standard practices to approve a new tuberculosis drug on Dec. 28.
Bedaquiline, produced by Johnson & Johnson under the trademarked name, Sirturo, is to be used in the treatment of multi-drug resistant pulmonary tuberculosis (MDR-TB).
MDR-TB is an extremely rare form of tuberculosis, affecting about 100 people in the United States and only about 600,000 world-wide according to J & J.
“Situro is being approved under the FDA’s accelerated approval program,” according to a press release by the FDA.
Under normal circumstances, new drugs are approved after a four-phase trial.
Phase 1 is normally conducted on 20-80 healthy people to determine the most frequent effects of the drug.
If phase 1 studies to not show an unacceptable level of toxic effects, phase 2 studies begin.
Phase 2 studies the effectiveness of the drug on anywhere from 12-300 patients. This phase studies the effectiveness of the drug versus the effectiveness of a placebo.
Phase 3 studies effectiveness on different population demographics and effectiveness of different dosage and use in combination with other drugs. This phase normally involves several hundred to several thousand people.
Phase 4 is the application process through the FDA. In this phase, the drug manufacturer submits all of its data from the studies to the FDA for approval or disapproval. It is the FDA’s responsibility to review the application for completeness within 60 days, then to determine approval or disapproval within 10 months.
The accelerated approval program allows drug manufacturers to skip this established practice and begin marketing the product before formal approval from the FDA.
The accelerated program allows the drug to be advertised as effective against a disease.
There are already four drugs on the market that treat TB. Those drugs are ineffective only in very rare cases.
To complete the normal course of study for the drug, many more human trials must be completed. Since so few people with TB are not able to be treated with the established course of treatment, most patients who could benefit from Situro, could easily be treated during the normal course of study.
Yet Situro has been approved to be advertised and sold after completing only 2 phase 2 trials. During the trials, 440 people were either given the drug or a placebo. Nine of those who received the drug died. One of the effects of the drug is changing the heart’s electrical activity which can lead to a potentially fatal heart rhythm.
Despite not following the scientific method established by itself, the FDA has approved Johnson & Johnson to market an unproven chemical as a treatment for a disease.
Can we expect to see commercials during the 2013 Superbowl with a cute computer generated cartoon character telling us to take Situro as a cough suppressant?