The US drug approval system has 2 important goals: getting safe and effective drugs rapidly to patients and rewarding innovation in the pharmaceutical industry by offering market exclusivity for new drugs. Unfortunately, there are weaknesses in our current system, as illustrated by this article concerning colchicine. Offering market exclusivity in the 21st century for a drug that has been used for the treatment of gout since the 18th century, with randomized control trials confirming this benefit from the 1980s, is not in the public service. A system that allows a drug that has been used for gout for centuries to be classified as a new discovery, with a price increase of 500% and generics forced off the market, is not in our patients' interest. Patients have little recourse unless regulations are changed to avoid allowing centuries-old drugs to become a profit-making vehicle for industry at the expense of access to patients.
Redberg RF. ColchicineComment on “The Colchicine Debacle”. JAMA Intern Med. 2013;173(3):185. doi:10.1001/jamainternmed.2013.3093