I need help.......

[Michael Gochfeld]

Paul's response to Pat Foley's posting is very reminiscent of what we 
hear and have heard from the biotech community.  The biotech industry 
did not take for granted that it had to prove safety and still argues 
that regulatory agencies have to prove harm. If it weren't for a very 
cynical public, suspicious of the motives of large industry, I would 
guess that the balance would not sway in favor of the regulatory 
agencies.  Like any statistical problem it is much easier to demonstrate 
harm (even when it is rare) than to provide convincing evidence of 
safety (even when it is common).  However, that alone should not shift 
the responsibility. 

M. Gochfeld