The current climate vilifies drug companies for adverse advents, with Vioxx being the prime example.
Not publicized however, is the number of potentially life saving drugs shelved because of this zero tolerance for risk.
Would medications like cholesterol-lowering statins be approved today? What about aspirin, which is known to cause GI toxicity and even death in rare cases?
Also unclear is whether now the FDA would approve a statin based on its LDL cholesterol-lowering ability alone, without definitive cardiovascular event data. Had the FDA taken that approach in the 1980s, many patients would not have had their lives saved by statins during the seven years required to obtain such information.
