A recent study published in the Journal of the American Medical Association has identified that one-third of FDA-approved drugs carry a safety risk that is found after the medications have already gone to market. It’s a rate that’s both alarming and unexpected from an agency that is supposedly charged with protecting the public’s health.
Joseph Ross, an associate professor of medicine and public health at Yale University and the study’s lead author, stated the importance of having “a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively.”
The FDA’s drug approval process brings into question whether it values such a course of action. All medications approved by the agency are supposed to be shown as safe and effective. But the studies used to demonstrate those requirements often involve less than 1,000 patients, and have a follow-up time that is frequently limited to six months or less. In addition, Eric Topol, the founder and director of Scripps Translational Science Institute, details that “clinical trials often cherry-pick patients likely to produce the best results,” according to the Washington Post.
The JAMA study reviewed 222 products that gained FDA approval between 2001 and 2010. It found that the agency had to take additional action on an astounding 71 of them. Three had to be completely removed from the market in order to protect consumers. Another 61 required a new black box warning, which is the most serious warning possible; and 59 needed further safety communications to doctors and patients about their potential dangers.
As if the need to audit its work so consistently wasn’t troubling enough, the FDA took more than four years on average to take additional safety action for each of the previously-approved drugs.
The well-known revolving door at FDA certainly doesn’t help its cause and may even contribute to its shortcomings. Numerous executives of big pharmaceutical companies often find themselves lending “their experience to the service of their government” only to quickly move on to industry lobbying positions. They go from roles designed to guard the public from profit-first corporations to roles whose sole purpose is focused on creating the relaxed policies that enable them. Meanwhile, thousands of unknowing consumers are left to use medications that could endanger their lives.
