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Unsafe Medicine: Shouldn't our government protect us from unsafe medicine?

Dr. David Graham's Testimony (November 18, 2004)

"Simply put, FDA and its Center for Drug Evaluation and Research [CDER] are broken."

To illustrate the "unreasonableness of CDER's standard of evidence," Dr. Graham uses the following analogies:

Analogy 1: The Weather-Man

"If the weather-man says there is an 80% chance of rain, most people would bring an umbrella. Using CDER’s standard, you wouldn’t bring an umbrella until there was a 95% or greater chance of rain."

Analogy 2: Russian Roulette

"The second analogy is more graphic, but I think it brings home the point more clearly. Imagine for a moment that you have a pistol with a barrel having 100 chambers. Now, randomly place 95 bullets into those chambers. The gun represents a drug and the bullets represent a serious safety problem. Using CDER’s standard, only when you have 95 bullets or more in the gun will you agree that the gun is loaded and a safety problem exists. Let’s remove 5 bullets at random. We now have 90 bullets distributed across 100 chambers. Because there is only a 90% chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe."