The American Spectator

One study by economists from the University of Chicago, MIT, Biogen Idec Inc., and Westfield Capital looked at all 662 drugs approved from 1979 to 2002 and concluded that, even if every withdrawn drug provided no benefits at all, the faster pace of approvals beginning in the 1990s benefited patients with an extra 180,000 to 310,000 years of life — roughly three to five times greater than the worst case estimate of harms.

FDA is once again under enormous pressure to slow down reviews. But, since there is no way to rule out the possibility of even very serious side effects by testing a drug in a few thousand patients, the only way to ensure no withdrawals is to approve no new medicines.

That would be the real patient tragedy. Congress and the FDA need to skip the grandstanding and get serious about bringing safe and effective new treatments to market. For millions of Americans like Senator Kennedy, it truly is a matter of life or death.