Friday, January 06, 2006

F the FDA

A good number of bloggers are rightly unhappy with the Food and Drug Administration for their decision to take Cylert off the market. It's a drug that helps those suffering from narcolepsy, but because it has been implicated in liver problems in some people, the FDA has pulled the plug on it completely. The inherent problems in the whole FDA approval process is exposed very well by Eric Raymond, who notes that if we choose to live by government regulation, than we also choose to die by government regulation:

The Cylert ban isn’t an accidental failure of the system, it’s an essential one. It wasn’t perpetrated by villains, but by well-intentioned people working the levers of a system designed to elevate “public safety” above individual choice. That system functioned as designed; it’s the design that’s broken.

Julian at Reason also points out that we as individual consumers are better able to make a personal risk assessment than the government:

The FDA's reason is that it has determined "the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug." Except, of course, that Teresa Nielsen Hayden obviously thought the benefits outweighed the risk. And, of course, there isn't really such thing as the "benefit" or "risk" of a drug in itself, but only the benefit and risk to a particular patient—not just because of physiological variation between people, but because of how we differently value the same sets of positive and negative effects. A sane FDA would give us the information and let us decide for ourselves which way the balance came out.

As they say, Asprin would never get through the current FDA approval process.

2 Comments:

At 9:25 AM, Blogger The Offensive Coordinator said...

Christine, what's your opinion as a pharmacist that patients should be given as much information as possible and then make their own decisions about risks associated with various drugs?

 
At 3:35 PM, Blogger The Offensive Coordinator said...

Thanks for your views, I was very curious as to what you thought about this subject.

 

Post a Comment

<< Home