My view is that we're not ready for that. |
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. |
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. |
There has been a series of blatant problems, ... This is the worst situation we've faced in decades at the FDA. |
There has been a series of blatant problems. This is the worst situation we've faced in decades at the FDA. |
These new data from the Mayo Clinic certainly help support the case for using aspirin before surgery. |
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. |
This is such a big and important medical technology, and there's not a systematic attempt in getting these devices interrogated if a patient dies. |