“The FDA did nothing to assure that the proper trials were conducted, but at the same time allowed mass-marketing campaigns with hundred of millions of dollars supporting direct-to-consumer advertising.”
“The [drug-approval] system was tested in ways it was never tested before. In an era of mass marketing, where data may show uncertainty and where the FDA has no real authority to take action, this class of drugs was set up to fail.”
“They actually were harmed. This was a trial to determine the boundaries of benefit, and it did. You don't use this drug for patients without coronary artery disease.”
