Kianna's Law

Instead of a wave of Terri's Laws that will introduce government intrusion into private family decisions, The Wall Street Journal suggests Kianna's Law, for Kianna Karnes, who died at the age of 44 from kidney cancer. She was denied any chance at clinical trials because our beloved FDA has a public to protect.

After her write-up in the Journal, the drug manufacturers and the FDA called to help. But...

But isn't it a national scandal that cancer sufferers should have to be written about in The Wall Street Journal to be offered legal access to emerging therapies once they've run out of other options?

The FDA's oncology division has proven to be essentially incorrigible on this point in recent years, so it's time for Congressional action mandating that the agency use 21st-century science and statistical methods to get these therapies to patients sooner. More specifically, drug approvals could be based on large trials open to all comers and analyzed with so-called Bayesian statistics, as already happens in the FDA's medical device division. (Yes, the agency at least recognizes that studies involving, say, "placebo" defibrillators would be beyond the pale.)

Mrs. Karnes's father John Rowe -- himself a leukemia survivor -- plans intense Congressional lobbying in the coming weeks, and he's had some interest from Congressman Dan Burton's (R., Indiana) office in the possibility of sponsoring a "Kianna's Law." No doubt there will be others willing to sign on.

Terri Schiavo was well served by the law. She got multiple chances for redress, and in the end got what her husband said she wanted. Kianna Karnes received no chances at what she clearly wanted -- to purchase drugs that might save her life.

Pharmaceuticals Posted by jk at March 29, 2005 5:24 PM