Saturday, April 21, 2007

An American duality

Let’s say you want to invent a killing machine. You have anything and everything at your disposal: toxins, germs, drugs, explosives, radiation, lasers, sharps, gears, and gadgets. If brought forth and marketed in the U.S., you can expect your invention to be highly scrutinized, its use heavily controlled and limited to a military or police setting. Unless, of course, it involves firing a projectile through a cylinder (one projectile per pull of the finger), in which case instead it will receive near immunity from regulation and instant approval for distribution to American homes.

Now let’s say you want to invent a new medicine, one that will cure a human disease. On average, you can expect laboratory and animal studies to take 3.5 years, your phase 1 clinical trial to establish basic safety one year, your phase 2 clinical trial to establish dosing and efficacy 2 years, your phase 3 clinical trial for further assessment of safety and efficacy 3 years, and your FDA review another 2.5 years. You will be lucky if your medicine can be sold on the market in less than 12 years.

It's the difference, I suppose, between protecting life and destroying it.