Tuesday, April 17, 2012

"Our life spans are much shorter than the FDA approval process."

Stunning story in today's WSJ about ALS patients who are making an experimental drug for ALS at home, on their own, and testing it on themselves. No FDA, no GLP, no IRBs, no control group - just patients in need doing what they can.

ALS (Lou Gehrig's disease) strikes fast, while the drug development, clinical testing, and regulatory approval processes moves slow. I understand the need of scientists and regulators for process, structure, and control, but I do not often enough see a reciprocal amount of flexibility or practicality in drug development. I've often wondered, for example, why we need placebo control arms in clinical trials targeting terminal diseases. Don't we already have a deep enough understanding of the life expectancy of a stage III lung cancer patient (for example)?

The one positive in the ALS article is the spirit of those with ALS who have taken up their own experimental effort. I admire their resourcefulness and fighting spirit.

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