I don't agree with your petition at all!
First, the letter only applies to medicines that treat type-2 diabetes, so it will not slow down a cure for type-1 at all.
Second, there have been a couple of drugs which actually got approved for type-2 diabetics which had bad side effects in terms of raising the chance of heart attacks. The FDA reacted to these problems by fixing their process: by requiring the drug companies to do testing focused specifically at heart risks. That is the right thing to do!
Prior to these new regulations, type-2 diabetic drugs could be approved after clinical trials lasting only 3-6 months. That's nuts! Those drugs are typically taken for years (maybe even decades). Requiring them to be tested for a year is long over due. The extra time is required to get a statistically valid sample of heart risk.
If we want a safe drug supply in this country, the FDA should go farther, and require post-approval (called "postmarket") safety testing lasting as long a the expected use of the drug. That is basic common sense. That would shake out a lot of safety issues before people got hurt, without slowing down drug approvals. But in the mean time, the FDA's rule change is a good step in the right direction. In my opinion.
Joshua Levy
From: Bernard Farrell <bernard.farrell@...>
To: nathanfaustmantrials@yahoogroups.com
Sent: Monday, January 5, 2009 8:15:01 PM
Subject: [nathanfaustmantrials] Ask FDA to better serve the needs of diabetes patients
A large group of us has started an online petition to the FDA.
We're asking them to remove new requirements they recently placed on
diabetes drugs.
Please sign. The petition is at: http://HealTheFDA. com/
If you want more details, I've posted them on my blog at
http://is.gd/ eEMB.