"I can't imagine anything more heart-wrenching than believing that you or a family member could be helped by something out there but you can't get it," says Weinstock. The FDA is in a difficult situation, he adds, because "they want to be as aggressive as possible in allowing people to have access to as many drugs as possible."
There's a misconception that the FDA is a bunch of bureaucrats, making arbitrary decisions based on politics — but Weinstock says it's actually "people like me, academics and scientists and clinicians, who get asked to serve on committees... and the overwhelming majority of the time, the FDA goes along with [our] decisions." Image via Nephron.
There are plenty of drugs that do a great job of shrinking tumors in mice, but turn out not to be suitable for humans, adds White. "Obviously you're excited [when a drug works on mice]. But the problem is that 95 percent of those new drug applications fail. They don't get FDA approval. 70 percent of them fail in that Phase One, which is the toxicity study. That leaves with you with 30 percent. And then 60 percent of those fail, and [most] of the time, it's because they don't work. That's nobody's fault. It isn't surprising that progress is slow."
"It's a tragedy when the drug is toxic and hurts people, and it's almost as tragic when the drug doesn't work," says Weinstock. "We've seen that recently with Avastin," which had its approval for breast cancer revoked.
"Very good people and very smart people spend their life trying to beat this disease," says White. "So every time you see a glimmer of hope, you hope that this is the great breakthrough... and obviously that gets hyped." Part of this is because you constantly have to seek more funding for your research, and everyone from members of Congress to your peers want to fund research that looks exciting. And then, of course, there's the media — and we certainly tend to get over-excited as well.
No comments:
Post a Comment