We Smell a Rat
Which group should the U.S. Food and Drug Administration care about more: humans or rats? That’s not a trick question. The FDA’s recent decision to reject the drug Horizant suggests that, at least in this case, it cares more about rats. And because of the FDA’s decision, some people (not rats) with restless legs syndrome (RLS) will suffer more.
This is from my latest, co-authored with Charley Hooper, “We Smell a Rat.”
Here’s how we end:
Seventeen years of human data in millions of patients showing that gabapentin doesn’t cause pancreatic cancer in humans were trumped by a two-year study in 200 rats given extremely high doses. The real danger to our health comes from such myopic views of safety and a hyperconservative, opaque, and capricious FDA keeping useful medicines out of the hands of American doctors and patients. The FDA needs to be reminded that it is reviewing drugs for humans, not for rodents.
The FDA is getting worse and worse.