Tuesday, May 24, 2011

FDA vs. Freedom

Mark McCarty of Medical Device Daily discusses the shenanigans and power-lust behind some of the FDA advisors.

Here's an excerpt from his 5/23/2011 post, "FDA advisory committees: Self-indulgence and the case for dismissal":
In a more recent advisory hearing, however, two panelists did a nice job of making themselves candidates for the Advisory Committee Hall of Shame. This hearing dealt with a treatment for a terminal cancer that would be approved only for patients whose disease twice failed to respond to other therapies, so it was not a light-hearted discussion. These patients are almost guaranteed to die within six months.

One panelist asked whether the treatment had been tested on healthy subjects, an absurd proposition on the face of it. As an example, it's not easy to get a healthy patient to climb into an MRI machine given how tight the spaces are, and one also suspects that it's just about impossible to get healthy subjects to volunteer for a CT scan for the sake of science, thanks to the recent flap over radiation dosing. The therapy under consideration is as yet utterly unfamiliar to the general public, so what are the chances? The balance of the panel declined to remark on the remark, and fortunately for all, this panelist let it drop.

But the development at this panel that really stuck with me was the vote by one panelist that the treatment in question -- we're still talking about a treatment for a twice-refractory, incredibly lethal cancer, mind you -- passed the test for safety and for efficacy, but this member of the panel nonetheless had the nerve to decree that the risk-benefit ratio was not up to par.
(Read the full text of his post, "FDA advisory committees: Self-indulgence and the case for dismissal".)

Remember, these are the people deciding whether you'll be permitted to benefit from potentially life-saving drugs and medical technology.

(Link via Vicki G.)