October 8, 2012 by MassDevice staff
Speaking alongside Boston Scientific (NYSE:BSX) co-founder John Abele at this week's AdvaMed 2012 conference in Boston, Fogarty said even doctors sometimes have difficulty figuring out whether a patient will benefit from a certain therapy.
"The fact is that we as physicians have a hard time, in some situations, determining what a risk is and what a benefit is, and when it will work for 1 patient but it won't work for another patient," Fogarty said. "And to think that an outside agency is prepared to do that is just wrong. They can't do that. ... The changes to technology outpace the ability of FDA and [the Centers for Medicare & Medicaid Services] to keep track of it."
Asked if the FDA isn't, in fact, a surrogate for protecting patients, Fogarty's initial answer was succinct.
"Bullshit," he said. "Patients should have a choice about their therapy. They aren't considered very often in that. Many times patients will accept different risks, and efficacy can be different with different patients. These patients are not stupid. They may make mistakes, but we as physicians make mistakes